DORA: A Study to Evaluate the Pharmacokinetics, Safety, and Efficacy of Glecaprevir/Pibrentasvir in Pediatric Subjects With Genotypes 1-6 Chronic Hepatitis C Virus (HCV) Infection
Sponsor
AbbVie (Industry)
Overall Status
Active, not recruiting
CT.gov ID
NCT03067129
Collaborator
(none)
127
38
4
68.1
3.3
0
Study Details
Study Description
Brief Summary
This is a Phase 2/3, open-label, multicenter study to evaluate the pharmacokinetics, efficacy,and safety of glecaprevir (GLE)/pibrentasvir (PIB) for 8, 12, or 16 weeks in Hepatitis C virus (HCV) genotype 1-6 (GT1 - GT6)-infected pediatric participants ≥ 3 to < 18 years of age, with or without compensated cirrhosis, with or without human immunodeficiency virus (HIV) coinfection, who were either treatment-naïve (TN), treatment-experienced (TE) with pegylated interferon (pegIFN) with or without ribavirin (RBV), or TE with sofosbuvir (SOF) + RBV with or without pegIFN. The study was divided into 2 parts, according to the formulation of GLE/PIB administered. Part 1 of the study enrolled HCV GT1 - GT6 infected adolescent participants into the ≥ 12 to < 18 years old age group who were willing to swallow the adult formulation of GLE/PIB (Cohort 1). Part 2 of the study enrolled HCV GT1 - GT6 infected pediatric participants divided into the ≥ 9 to < 12 (Cohort 2), ≥ 6 to < 9 (Cohort 3), and ≥ 3 to < 6 (Cohort 4) years old age groups, who received the pediatric formulation of GLE + PIB.
Interim data are presented for all participants in Parts 1 and 2 who completed post-treatment Week 12 or prematurely discontinued from the study.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 2/Phase 3 |
Study Design
Study Type:
Interventional
Actual Enrollment
:
127 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
An Open-Label, Multicenter Study to Evaluate the Pharmacokinetics, Safety, and Efficacy of Glecaprevir/Pibrentasvir in Pediatric Subjects With Genotypes 1-6 Chronic Hepatitis C Virus (HCV) Infection
Actual Study Start Date
:
Mar 20, 2017
Actual Primary Completion Date
:
May 21, 2020
Anticipated Study Completion Date
:
Nov 21, 2022
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Cohort 1: Adult formulation GLE/PIB, participants 12 to < 18 yrs Adult formulation of glecaprevir (GLE)/pibrentasvir (PIB) 300 mg/120 mg co-formulated film-coated tablets once daily (QD) by mouth for 8, 12, or 16 weeks depending on hepatitis C virus (HCV) genotype, cirrhosis status, and prior treatment experience in participants 12 to < 18 years of age |
Drug: Glecaprevir/pibrentasvir adult formulation
Film-coated tablet (100 mg/40 mg)
Other Names:
|
| Experimental: Cohort 2: Pediatric formulation GLE/PIB, participants 9 to < 12 yrs Pediatric formulation of separate glecaprevir (GLE)/pibrentasvir (PIB)15.67% and 8.25% film-coated pellets/granules dosed based on body weight/age once daily (QD) by mouth for 8, 12, or 16 weeks depending on HCV genotype, cirrhosis status, and prior treatment experience in participants 9 to < 12 years of age |
Drug: Glecaprevir/pibrentasvir pediatric formulation
Film-coated pellets/granules (15.67%/8.25%)
Other Names:
|
| Experimental: Cohort 3: Pediatric formulation GLE/PIB, participants 6 to < 9 yrs Pediatric formulation of separate glecaprevir (GLE)/pibrentasvir (PIB)15.67% and 8.25% film-coated pellets/granules dosed based on body weight/age once daily (QD) by mouth for 8, 12, or 16 weeks depending on HCV genotype, cirrhosis status, and prior treatment experience in participants 6 to < 9 years of age |
Drug: Glecaprevir/pibrentasvir pediatric formulation
Film-coated pellets/granules (15.67%/8.25%)
Other Names:
|
| Experimental: Cohort 4: Pediatric formulation GLE/PIB, participants 3 to < 6 yrs Pediatric formulation of separate glecaprevir (GLE)/pibrentasvir (PIB)15.67% and 8.25% film-coated pellets/granules dosed based on body weight/age once daily (QD) by mouth for 8, 12, or 16 weeks depending on HCV genotype, cirrhosis status, and prior treatment experience in participants 3 to < 6 years of age |
Drug: Glecaprevir/pibrentasvir pediatric formulation
Film-coated pellets/granules (15.67%/8.25%)
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Steady-state Area Under the Plasma Concentration-time Curve (AUC) of Glecaprevir (GLE) at Week 2 [At Week 2]
AUC is a measure of how long and how much drug is present in the body after dosing. The amount of glecaprevir present was measured up to 24 hours after dosing and estimated using non-compartmental analysis.
- Steady-state Area Under the Plasma Concentration-time Curve (AUC) of Pibrentasvir (PIB) at Week 2 [At Week 2]
AUC is a measure of how long and how much drug is present in the body after dosing. The amount of pibrentasvir present was measured up to 24 hours after dosing and estimated using non-compartmental analysis.
- Percentage of Participants With Sustained Virologic Response 12 Weeks Post Treatment (SVR12) [12 weeks after last dose of study drug (Week 20, 24, or 28 depending on treatment duration)]
SVR12 is defined as hepatitis C virus ribonucleic acid (HCV RNA) < lower limit of quantification (LLOQ) 12 weeks after the last actual dose of study drug.
Secondary Outcome Measures
- Maximum Plasma Concentration (Cmax) of Glecaprevir (GLE) at Week 2 [At Week 2]
Cmax is the peak concentration that a drug or drug metabolite achieves in a specified compartment after the drug has been administered and before administration of a second dose. It was estimated by non-compartmental pharmacokinetic analysis.
- Clearance (CL) of Glecaprevir (GLE) From Plasma at Week 2 [At Week 2]
CL is a quantitative measure of the rate at which a drug substance is removed from the body. It was estimated by non-compartmental pharmacokinetic analysis.
- Maximum Plasma Concentration (Cmax) of Pibrentasvir (PIB) at Week 2 [At Week 2]
Cmax is the peak concentration that a drug or drug metabolite achieves in a specified compartment after the drug has been administered and before administration of a second dose. It was estimated by non-compartmental pharmacokinetic analysis.
- Clearance (CL) of Pibrentasvir (PIB) From Plasma at Week 2 [At Week 2]
CL is a quantitative measure of the rate at which a drug substance is removed from the body. It was estimated by non-compartmental pharmacokinetic analysis.
- Percentage of Participants Who Experienced On-treatment Virologic Failure [Up to Week 8, 12, or 16 (depending on treatment duration)]
On-treatment virologic failure is defined as hepatitis C virus ribonucleic acid (HCV RNA) confirmed increase of > 1 (subscript)10(subscript) IU/mL above nadir during treatment, confirmed HCV RNA ≥ 100 IU/mL after HCV RNA < lower limit of quantification (LLOQ) during treatment, or HCV RNA ≥ LLOQ at the end of treatment with at least 6 weeks of treatment.
- Percentage of Participants With Post-treatment Relapse [Up to 12 weeks after the last dose of study drug (Week 20, 24, or 28 depending on treatment duration)]
Post-treatment relapse is defined as confirmed hepatitis C virus ribonucleic acid (HCV RNA) ≥ the lower limit of quantification (LLOQ) between the end of treatment and 12 weeks after the last dose of study drug among participants who completed treatment as planned with HCV RNA < LLOQ at the end of treatment; excluding participants who had been shown to be re-infected.
- Percentage of Participants With New Hepatitis C Virus (HCV) Infection (i.e., Reinfection) [Up to 12 weeks after last dose of study drug (Week 20, 24, or 28 depending on treatment duration)]
Reinfection is defined as confirmed hepatitis C virus ribonucleic acid (HCV RNA) ≥ the lower limit of quantification (LLOQ) in the post-treatment period along with post-treatment detection of a different HCV genotype, subtype, or clade compared with baseline.
- Palatability Questionnaire Question 1: How Convenient or Inconvenient Was it to Prepare the Dose? [At the End of Treatment visit or at the premature discontinuation visit (up to 8, 12, or 16 weeks, depending on treatment duration)]
For each participant who received the pediatric formulation (Cohorts 2 - 4), the parent(s)/guardian(s) completed a Palatability Questionnaire to provide feedback on the perception of the dosage form. The Palatability Questionnaire included 6 questions related to the administration and ingestion of the pediatric GLE/PIB formulation.
- Palatability Questionnaire Question 2: How Long Did it Typically Take for the Child to Take the Dose? [At the End of Treatment visit or at the premature discontinuation visit (up to 8, 12, or 16 weeks, depending on treatment duration)]
For each participant who received the pediatric formulation (Cohorts 2 - 4), the parent(s)/guardian(s) completed a Palatability Questionnaire to provide feedback on the perception of the dosage form. The Palatability Questionnaire included 6 questions related to the administration and ingestion of the pediatric GLE/PIB formulation.
- Palatability Questionnaire Question 3: Were You Able to Successfully Administer the Whole Dose to the Child With 1 to 2 Teaspoons (5 to 10 mL) of Soft Food? [At the End of Treatment visit or at the premature discontinuation visit (up to 8, 12, or 16 weeks, depending on treatment duration)]
For each participant who received the pediatric formulation (Cohorts 2 - 4), the parent(s)/guardian(s) completed a Palatability Questionnaire to provide feedback on the perception of the dosage form. The Palatability Questionnaire included 6 questions related to the administration and ingestion of the pediatric GLE/PIB formulation.
- Palatability Questionnaire Question 4: Did You Experience Any Resistance When Feeding the Child the Medicine? [At the End of Treatment visit or at the premature discontinuation visit (up to 8, 12, or 16 weeks, depending on treatment duration)]
For each participant who received the pediatric formulation (Cohorts 2 - 4), the parent(s)/guardian(s) completed a Palatability Questionnaire to provide feedback on the perception of the dosage form. The Palatability Questionnaire included 6 questions related to the administration and ingestion of the pediatric GLE/PIB formulation.
- Palatability Questionnaire Question 4a: Type of Feeding Resistance [At the End of Treatment visit or at the premature discontinuation visit (up to 8, 12, or 16 weeks, depending on treatment duration)]
For each participant who received the pediatric formulation (Cohorts 2 - 4), the parent(s)/guardian(s) completed a Palatability Questionnaire to provide feedback on the perception of the dosage form. The Palatability Questionnaire included 6 questions related to the administration and ingestion of the pediatric GLE/PIB formulation.
- Palatability Questionnaire Question 5: How Easy or Difficult Was it for the Child to Swallow the Medicine? [At the End of Treatment visit or at the premature discontinuation visit (up to 8, 12, or 16 weeks, depending on treatment duration)]
For each participant who received the pediatric formulation (Cohorts 2 - 4), the parent(s)/guardian(s) completed a Palatability Questionnaire to provide feedback on the perception of the dosage form. The Palatability Questionnaire included 6 questions related to the administration and ingestion of the pediatric GLE/PIB formulation.
Eligibility Criteria
Criteria
Ages Eligible for Study:
3 Years
to 17 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
- Hepatitis C virus (HCV) infection demonstrated by positive anti-HCV antibody (Ab) and HCV Ribonucleic acid (RNA) greater than or equal to 1000 IU/ mL
Exclusion Criteria:
-
Females who are pregnant or breastfeeding
-
Positive test result for Hepatitis B surface antigen (HbsAg) or positive test result for HBV DNA
-
Participants with other known liver diseases
-
Decompensated cirrhosis defined as: presence of ascites, history of variceal bleeding, lab values consistent with Child-Pugh class B or C cirrhosis
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Univ of California San Francis /ID# 158002 | San Francisco | California | United States | 94158 |
| 2 | Childrens Hospital Colorado /ID# 157996 | Aurora | Colorado | United States | 80045 |
| 3 | CT Childrens Medical Ctr, US /ID# 158639 | Hartford | Connecticut | United States | 06106 |
| 4 | UF Hepatology Research at CTRB /ID# 158008 | Gainesville | Florida | United States | 32610-0272 |
| 5 | Advent Health /ID# 166022 | Orlando | Florida | United States | 32803 |
| 6 | Indiana University /ID# 158001 | Indianapolis | Indiana | United States | 46202 |
| 7 | Boston Childrens Hospital /ID# 157988 | Boston | Massachusetts | United States | 02115 |
| 8 | Boston Medical Center /ID# 157997 | Boston | Massachusetts | United States | 02118 |
| 9 | Columbia Univ Medical Center /ID# 158000 | New York | New York | United States | 10032-3725 |
| 10 | UNC Health Care /ID# 157991 | Chapel Hill | North Carolina | United States | 27514 |
| 11 | Cincinnati Childrens Hosp Med /ID# 158007 | Cincinnati | Ohio | United States | 45229 |
| 12 | Children's Hospital of Philadelphia /ID# 158003 | Philadelphia | Pennsylvania | United States | 19104 |
| 13 | Child Hosp of Pittsburgh,PA /ID# 158004 | Pittsburgh | Pennsylvania | United States | 15213-2583 |
| 14 | Monroe-Carell Jr. Children's H /ID# 169037 | Nashville | Tennessee | United States | 37232 |
| 15 | Baylor College of Medicine /ID# 157989 | Houston | Texas | United States | 77030-3411 |
| 16 | Cliniques Universitaires Saint Luc /ID# 162173 | Woluwe-Saint-Lambert | Bruxelles-Capitale | Belgium | 1200 |
| 17 | UZ Leuven /ID# 162174 | Leuven | Belgium | 3000 | |
| 18 | Alberta Children's Hospital /ID# 163449 | Calgary | Alberta | Canada | T3B 6A9 |
| 19 | Stollery Children's Hospital /ID# 163450 | Edmonton | Alberta | Canada | T6G 2X8 |
| 20 | Hospital for Sick Children /ID# 163448 | Toronto | Ontario | Canada | M5G 1X8 |
| 21 | Universitatsklinikum Freiburg /ID# 165187 | Freiburg im Breisgau | Baden-Wuerttemberg | Germany | 79106 |
| 22 | Charite Universitaetsmedizin Berlin /ID# 165186 | Berlin | Germany | 10117 | |
| 23 | Helios Klinikum Wuppertal /ID# 165185 | Wuppertal | Germany | 42283 | |
| 24 | Kurume University Hospital /ID# 165718 | Kurume-shi | Fukuoka | Japan | 830-0011 |
| 25 | Osaka General Medical Center /ID# 212745 | Osaka-shi | Osaka | Japan | 558-8558 |
| 26 | Osaka University Hospital /ID# 165709 | Suita-shi | Osaka | Japan | 565-0871 |
| 27 | Juntendo University Hospital /ID# 212912 | Bunkyo-ku | Tokyo | Japan | 113-8431 |
| 28 | San Jorge Children Hospital /ID# 160850 | San Juan | Puerto Rico | 00912-3310 | |
| 29 | Federal State Budgetary Institution - Institute of Nutrition /ID# 163345 | Moscow | Moskva | Russian Federation | 109240 |
| 30 | National Medical Scientific Centre of children health /ID# 163344 | Moscow | Moskva | Russian Federation | 119296 |
| 31 | Scientific and Research Institute of pediatric infections /ID# 163343 | Saint-petersburg | Russian Federation | 197022 | |
| 32 | Hospital Sant Joan de Deu /ID# 163282 | Esplugues de Llobregat | Barcelona | Spain | 08950 |
| 33 | Hospital Universitario Vall d'Hebron /ID# 163323 | Barcelona | Spain | 08035 | |
| 34 | Hospital Universitario La Paz /ID# 163283 | Madrid | Spain | 28046 | |
| 35 | Hospital Universitario y Politecnico La Fe /ID# 163325 | Valencia | Spain | 46026 | |
| 36 | Birmingham Childrens Hospital /ID# 162718 | Birmingham | United Kingdom | B4 6NH | |
| 37 | Queen Elizabeth University Hos /ID# 162719 | Glasgow | United Kingdom | G514TF | |
| 38 | King's College Hospital NHS /ID# 162717 | London | United Kingdom | SE5 9RS |
Sponsors and Collaborators
- AbbVie
Investigators
- Study Director: AbbVie Inc., AbbVie
Study Documents (Full-Text)
More Information
Publications
None provided.Responsible Party:
AbbVie
ClinicalTrials.gov Identifier:
NCT03067129
Other Study ID Numbers:
- M16-123
- 2016-004102-34
First Posted:
Mar 1, 2017
Last Update Posted:
Jun 23, 2022
Last Verified:
Jun 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No
Product Manufactured in and Exported from the U.S.:
No
Keywords provided by AbbVie
Additional relevant MeSH terms:
Study Results
Participant Flow
| Recruitment Details | |
|---|---|
| Pre-assignment Detail | Safety population: all participants who received at least 1 dose of study drug |
| Arm/Group Title | Cohort 1: Adult Formulation GLE/PIB, Participants 12 to < 18 Yrs | Cohort 2: Pediatric Formulation GLE/PIB, Participants 9 to < 12 Yrs | Cohort 3: Pediatric Formulation GLE/PIB, Participants 6 to < 9 Yrs | Cohort 4: Pediatric Formulation GLE/PIB, Participants 3 to < 6 Yrs |
|---|---|---|---|---|
| Arm/Group Description | Adult formulation of glecaprevir (GLE)/pibrentasvir (PIB) 300 mg/120 mg co-formulated film-coated tablets once daily (QD) by mouth for 8, 12, or 16 weeks depending on hepatitis C virus (HCV) genotype, cirrhosis status, and prior treatment experience in participants 12 to < 18 years of age | Pediatric formulation of separate glecaprevir (GLE)/pibrentasvir (PIB)15.67% and 8.25% film-coated pellets/granules dosed based on body weight/age once daily (QD) by mouth for 8, 12, or 16 weeks depending on HCV genotype, cirrhosis status, and prior treatment experience in participants 9 to < 12 years of age | Pediatric formulation of separate glecaprevir (GLE)/pibrentasvir (PIB)15.67% and 8.25% film-coated pellets/granules dosed based on body weight/age once daily (QD) by mouth for 8, 12, or 16 weeks depending on HCV genotype, cirrhosis status, and prior treatment experience in participants 6 to < 9 years of age | Pediatric formulation of separate glecaprevir (GLE)/pibrentasvir (PIB)15.67% and 8.25% film-coated pellets/granules dosed based on body weight/age once daily (QD) by mouth for 8, 12, or 16 weeks depending on HCV genotype, cirrhosis status, and prior treatment experience in participants 3 to < 6 years of age |
| Period Title: Overall Study | ||||
| STARTED | 47 | 29 | 27 | 24 |
| COMPLETED | 2 | 1 | 0 | 0 |
| NOT COMPLETED | 45 | 28 | 27 | 24 |
Baseline Characteristics
| Arm/Group Title | Cohort 1: Adult Formulation GLE/PIB, Participants 12 to < 18 Yrs | Cohort 2: Pediatric Formulation GLE/PIB, Participants 9 to < 12 Yrs | Cohort 3: Pediatric Formulation GLE/PIB, Participants 6 to < 9 Yrs | Cohort 4: Pediatric Formulation GLE/PIB, Participants 3 to < 6 Yrs | Total |
|---|---|---|---|---|---|
| Arm/Group Description | Adult formulation of glecaprevir (GLE)/pibrentasvir (PIB) 300 mg/120 mg co-formulated film-coated tablets once daily (QD) by mouth for 8, 12, or 16 weeks depending on hepatitis C virus (HCV) genotype, cirrhosis status, and prior treatment experience in participants 12 to < 18 years of age | Pediatric formulation of separate glecaprevir (GLE)/pibrentasvir (PIB)15.67% and 8.25% film-coated pellets/granules dosed based on body weight/age once daily (QD) by mouth for 8, 12, or 16 weeks depending on HCV genotype, cirrhosis status, and prior treatment experience in participants 9 to < 12 years of age | Pediatric formulation of separate glecaprevir (GLE)/pibrentasvir (PIB)15.67% and 8.25% film-coated pellets/granules dosed based on body weight/age once daily (QD) by mouth for 8, 12, or 16 weeks depending on HCV genotype, cirrhosis status, and prior treatment experience in participants 6 to < 9 years of age | Pediatric formulation of separate glecaprevir (GLE)/pibrentasvir (PIB)15.67% and 8.25% film-coated pellets/granules dosed based on body weight/age once daily (QD) by mouth for 8, 12, or 16 weeks depending on HCV genotype, cirrhosis status, and prior treatment experience in participants 3 to < 6 years of age | Total of all reporting groups |
| Overall Participants | 47 | 29 | 27 | 24 | 127 |
| Age (years) [Mean (Standard Deviation) ] | |||||
| Mean (Standard Deviation) [years] |
14.26
(1.51)
|
10.00
(0.85)
|
7.11
(0.89)
|
3.79
(0.78)
|
9.79
(4.14)
|
| Sex: Female, Male (Count of Participants) | |||||
| Female |
26
55.3%
|
15
51.7%
|
17
63%
|
12
50%
|
70
55.1%
|
| Male |
21
44.7%
|
14
48.3%
|
10
37%
|
12
50%
|
57
44.9%
|
| Race/Ethnicity, Customized (Count of Participants) | |||||
| White |
35
74.5%
|
21
72.4%
|
18
66.7%
|
16
66.7%
|
90
70.9%
|
| Black or African American |
4
8.5%
|
1
3.4%
|
1
3.7%
|
1
4.2%
|
7
5.5%
|
| Asian |
6
12.8%
|
5
17.2%
|
5
18.5%
|
4
16.7%
|
20
15.7%
|
| American Indian or Alaska Native |
0
0%
|
1
3.4%
|
0
0%
|
1
4.2%
|
2
1.6%
|
| Native Hawaiian or other Pacific Islander |
0
0%
|
0
0%
|
0
0%
|
1
4.2%
|
1
0.8%
|
| Multiple |
2
4.3%
|
1
3.4%
|
3
11.1%
|
1
4.2%
|
7
5.5%
|
| Baseline Fibrosis Stage (Count of Participants) | |||||
| F0-F1 |
45
95.7%
|
28
96.6%
|
26
96.3%
|
24
100%
|
123
96.9%
|
| F2 |
1
2.1%
|
1
3.4%
|
1
3.7%
|
0
0%
|
3
2.4%
|
| F3 |
1
2.1%
|
0
0%
|
0
0%
|
0
0%
|
1
0.8%
|
| F4 |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Co-infection with Human Immunodeficiency Virus (HIV) (Count of Participants) | |||||
| Yes |
2
4.3%
|
0
0%
|
1
3.7%
|
0
0%
|
3
2.4%
|
| No |
45
95.7%
|
29
100%
|
26
96.3%
|
24
100%
|
124
97.6%
|
Outcome Measures
| Title | Steady-state Area Under the Plasma Concentration-time Curve (AUC) of Glecaprevir (GLE) at Week 2 |
|---|---|
| Description | AUC is a measure of how long and how much drug is present in the body after dosing. The amount of glecaprevir present was measured up to 24 hours after dosing and estimated using non-compartmental analysis. |
| Time Frame | At Week 2 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Part 1 participants with intensive pharmacokinetic (IPK) sampling in Part 1 (3 participants were excluded due to abnormally low values at the Week 2 visit) and Part 2 participants with IPK sampling in Part 2 following the final proposed dosing regimen (1 participant in Cohort 4 received 200/80 mg dose [weight > 20kg] and was summarized in Cohort 3 based on actual dose received) |
| Arm/Group Title | Cohort 1: Adult Formulation GLE/PIB, Participants 12 to < 18 Yrs | Cohort 2: Pediatric Formulation GLE/PIB, Participants 9 to < 12 Yrs | Cohort 3: Pediatric Formulation GLE/PIB, Participants 6 to < 9 Yrs | Cohort 4: Pediatric Formulation GLE/PIB, Participants 3 to < 6 Yrs |
|---|---|---|---|---|
| Arm/Group Description | Adult formulation of glecaprevir (GLE)/pibrentasvir (PIB) 300 mg/120 mg co-formulated film-coated tablets once daily (QD) by mouth for 8, 12, or 16 weeks depending on hepatitis C virus (HCV) genotype, cirrhosis status, and prior treatment experience in participants 12 to < 18 years of age | Pediatric formulation of separate glecaprevir (GLE)/pibrentasvir (PIB)15.67% and 8.25% film-coated pellets/granules dosed based on body weight/age once daily (QD) by mouth for 8, 12, or 16 weeks depending on HCV genotype, cirrhosis status, and prior treatment experience in participants 9 to < 12 years of age | Pediatric formulation of separate glecaprevir (GLE)/pibrentasvir (PIB)15.67% and 8.25% film-coated pellets/granules dosed based on body weight/age once daily (QD) by mouth for 8, 12, or 16 weeks depending on HCV genotype, cirrhosis status, and prior treatment experience in participants 6 to < 9 years of age | Pediatric formulation of separate glecaprevir (GLE)/pibrentasvir (PIB)15.67% and 8.25% film-coated pellets/granules dosed based on body weight/age once daily (QD) by mouth for 8, 12, or 16 weeks depending on HCV genotype, cirrhosis status, and prior treatment experience in participants 3 to < 6 years of age |
| Measure Participants | 14 | 13 | 13 | 12 |
| Geometric Mean (95% Confidence Interval) [ng•h/mL] |
4790
|
7870
|
6860
|
7520
|
| Title | Steady-state Area Under the Plasma Concentration-time Curve (AUC) of Pibrentasvir (PIB) at Week 2 |
|---|---|
| Description | AUC is a measure of how long and how much drug is present in the body after dosing. The amount of pibrentasvir present was measured up to 24 hours after dosing and estimated using non-compartmental analysis. |
| Time Frame | At Week 2 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Part 1 participants with intensive pharmacokinetic (IPK) sampling in Part 1 (3 participants were excluded due to abnormally low values at the Week 2 visit) and Part 2 participants with IPK sampling in Part 2 following the final proposed dosing regimen (1 participant in Cohort 4 received 200/80 mg dose [weight > 20kg] and was summarized in Cohort 3 based on actual dose received) |
| Arm/Group Title | Cohort 1: Adult Formulation GLE/PIB, Participants 12 to < 18 Yrs | Cohort 2: Pediatric Formulation GLE/PIB, Participants 9 to < 12 Yrs | Cohort 3: Pediatric Formulation GLE/PIB, Participants 6 to < 9 Yrs | Cohort 4: Pediatric Formulation GLE/PIB, Participants 3 to < 6 Yrs |
|---|---|---|---|---|
| Arm/Group Description | Adult formulation of glecaprevir (GLE)/pibrentasvir (PIB) 300 mg/120 mg co-formulated film-coated tablets once daily (QD) by mouth for 8, 12, or 16 weeks depending on hepatitis C virus (HCV) genotype, cirrhosis status, and prior treatment experience in participants 12 to < 18 years of age | Pediatric formulation of separate glecaprevir (GLE)/pibrentasvir (PIB)15.67% and 8.25% film-coated pellets/granules dosed based on body weight/age once daily (QD) by mouth for 8, 12, or 16 weeks depending on HCV genotype, cirrhosis status, and prior treatment experience in participants 9 to < 12 years of age | Pediatric formulation of separate glecaprevir (GLE)/pibrentasvir (PIB)15.67% and 8.25% film-coated pellets/granules dosed based on body weight/age once daily (QD) by mouth for 8, 12, or 16 weeks depending on HCV genotype, cirrhosis status, and prior treatment experience in participants 6 to < 9 years of age | Pediatric formulation of separate glecaprevir (GLE)/pibrentasvir (PIB)15.67% and 8.25% film-coated pellets/granules dosed based on body weight/age once daily (QD) by mouth for 8, 12, or 16 weeks depending on HCV genotype, cirrhosis status, and prior treatment experience in participants 3 to < 6 years of age |
| Measure Participants | 14 | 13 | 13 | 12 |
| Geometric Mean (95% Confidence Interval) [ng•h/mL] |
1380
|
2200
|
1640
|
1790
|
| Title | Percentage of Participants With Sustained Virologic Response 12 Weeks Post Treatment (SVR12) |
|---|---|
| Description | SVR12 is defined as hepatitis C virus ribonucleic acid (HCV RNA) < lower limit of quantification (LLOQ) 12 weeks after the last actual dose of study drug. |
| Time Frame | 12 weeks after last dose of study drug (Week 20, 24, or 28 depending on treatment duration) |
Outcome Measure Data
| Analysis Population Description |
|---|
| Intention-to-treat (ITT population): all participants who received at least 1 dose of study drug; those with missing data after backwards imputation were counted as nonresponders |
| Arm/Group Title | Cohort 1: Adult Formulation GLE/PIB, Participants 12 to < 18 Yrs | Cohort 2: Pediatric Formulation GLE/PIB, Participants 9 to < 12 Yrs | Cohort 3: Pediatric Formulation GLE/PIB, Participants 6 to < 9 Yrs | Cohort 4: Pediatric Formulation GLE/PIB, Participants 3 to < 6 Yrs | Cohorts 2- 4: Pediatric Formulation GLE/PIB, Participants 3 to < 12 Yrs | Participants in Cohorts 1, 2, 3, and 4 |
|---|---|---|---|---|---|---|
| Arm/Group Description | Adult formulation of glecaprevir (GLE)/pibrentasvir (PIB) 300 mg/120 mg co-formulated film-coated tablets once daily (QD) by mouth for 8, 12, or 16 weeks depending on hepatitis C virus (HCV) genotype, cirrhosis status, and prior treatment experience in participants 12 to < 18 years of age | Pediatric formulation of separate glecaprevir (GLE)/pibrentasvir (PIB)15.67% and 8.25% film-coated pellets/granules dosed based on body weight/age once daily (QD) by mouth for 8, 12, or 16 weeks depending on HCV genotype, cirrhosis status, and prior treatment experience in participants 9 to < 12 years of age | Pediatric formulation of separate glecaprevir (GLE)/pibrentasvir (PIB)15.67% and 8.25% film-coated pellets/granules dosed based on body weight/age once daily (QD) by mouth for 8, 12, or 16 weeks depending on HCV genotype, cirrhosis status, and prior treatment experience in participants 6 to < 9 years of age | Pediatric formulation of separate glecaprevir (GLE)/pibrentasvir (PIB)15.67% and 8.25% film-coated pellets/granules dosed based on body weight/age once daily (QD) by mouth for 8, 12, or 16 weeks depending on HCV genotype, cirrhosis status, and prior treatment experience in participants 3 to < 6 years of age | Pediatric formulation of separate glecaprevir (GLE)/pibrentasvir (PIB) 15.67% and 8.25% film-coated pellets/granules dosed based on body weight/age once daily (QD) by mouth for 8, 12, or 16 weeks depending on HCV genotype, cirrhosis status, and prior treatment experience in participants 3 to < 12 years of age | Participants who received at least 1 dose of study drug |
| Measure Participants | 47 | 29 | 27 | 24 | 80 | 127 |
| Number (95% Confidence Interval) [percentage of participants] |
100
212.8%
|
93.1
321%
|
100
370.4%
|
95.8
399.2%
|
96.3
75.8%
|
97.6
NaN
|
| Title | Maximum Plasma Concentration (Cmax) of Glecaprevir (GLE) at Week 2 |
|---|---|
| Description | Cmax is the peak concentration that a drug or drug metabolite achieves in a specified compartment after the drug has been administered and before administration of a second dose. It was estimated by non-compartmental pharmacokinetic analysis. |
| Time Frame | At Week 2 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Part 1 participants with intensive pharmacokinetic (IPK) sampling in Part 1 (3 participants were excluded due to abnormally low values at the Week 2 visit) and Part 2 participants with IPK sampling in Part 2 following the final proposed dosing regimen (1 participant in Cohort 4 received 200/80 mg dose [weight > 20kg] and was summarized in Cohort 3 based on actual dose received) |
| Arm/Group Title | Cohort 1: Adult Formulation GLE/PIB, Participants 12 to < 18 Yrs | Cohort 2: Pediatric Formulation GLE/PIB, Participants 9 to < 12 Yrs | Cohort 3: Pediatric Formulation GLE/PIB, Participants 6 to < 9 Yrs | Cohort 4: Pediatric Formulation GLE/PIB, Participants 3 to < 6 Yrs |
|---|---|---|---|---|
| Arm/Group Description | Adult formulation of glecaprevir (GLE)/pibrentasvir (PIB) 300 mg/120 mg co-formulated film-coated tablets once daily (QD) by mouth for 8, 12, or 16 weeks depending on hepatitis C virus (HCV) genotype, cirrhosis status, and prior treatment experience in participants 12 to < 18 years of age | Pediatric formulation of separate glecaprevir (GLE)/pibrentasvir (PIB)15.67% and 8.25% film-coated pellets/granules dosed based on body weight/age once daily (QD) by mouth for 8, 12, or 16 weeks depending on HCV genotype, cirrhosis status, and prior treatment experience in participants 9 to < 12 years of age | Pediatric formulation of separate glecaprevir (GLE)/pibrentasvir (PIB)15.67% and 8.25% film-coated pellets/granules dosed based on body weight/age once daily (QD) by mouth for 8, 12, or 16 weeks depending on HCV genotype, cirrhosis status, and prior treatment experience in participants 6 to < 9 years of age | Pediatric formulation of separate glecaprevir (GLE)/pibrentasvir (PIB)15.67% and 8.25% film-coated pellets/granules dosed based on body weight/age once daily (QD) by mouth for 8, 12, or 16 weeks depending on HCV genotype, cirrhosis status, and prior treatment experience in participants 3 to < 6 years of age |
| Measure Participants | 14 | 13 | 13 | 12 |
| Geometric Mean (95% Confidence Interval) [ng/mL] |
1040
|
1370
|
1600
|
1530
|
| Title | Clearance (CL) of Glecaprevir (GLE) From Plasma at Week 2 |
|---|---|
| Description | CL is a quantitative measure of the rate at which a drug substance is removed from the body. It was estimated by non-compartmental pharmacokinetic analysis. |
| Time Frame | At Week 2 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Part 1 participants with intensive pharmacokinetic (IPK) sampling in Part 1 (3 participants were excluded due to abnormally low values at the Week 2 visit) and Part 2 participants with IPK sampling in Part 2 following the final proposed dosing regimen (1 participant in Cohort 4 received 200/80 mg dose [weight > 20kg] and was summarized in Cohort 3 based on actual dose received) |
| Arm/Group Title | Cohort 1: Adult Formulation GLE/PIB, Participants 12 to < 18 Yrs | Cohort 2: Pediatric Formulation GLE/PIB, Participants 9 to < 12 Yrs | Cohort 3: Pediatric Formulation GLE/PIB, Participants 6 to < 9 Yrs | Cohort 4: Pediatric Formulation GLE/PIB, Participants 3 to < 6 Yrs |
|---|---|---|---|---|
| Arm/Group Description | Adult formulation of glecaprevir (GLE)/pibrentasvir (PIB) 300 mg/120 mg co-formulated film-coated tablets once daily (QD) by mouth for 8, 12, or 16 weeks depending on hepatitis C virus (HCV) genotype, cirrhosis status, and prior treatment experience in participants 12 to < 18 years of age | Pediatric formulation of separate glecaprevir (GLE)/pibrentasvir (PIB)15.67% and 8.25% film-coated pellets/granules dosed based on body weight/age once daily (QD) by mouth for 8, 12, or 16 weeks depending on HCV genotype, cirrhosis status, and prior treatment experience in participants 9 to < 12 years of age | Pediatric formulation of separate glecaprevir (GLE)/pibrentasvir (PIB)15.67% and 8.25% film-coated pellets/granules dosed based on body weight/age once daily (QD) by mouth for 8, 12, or 16 weeks depending on HCV genotype, cirrhosis status, and prior treatment experience in participants 6 to < 9 years of age | Pediatric formulation of separate glecaprevir (GLE)/pibrentasvir (PIB)15.67% and 8.25% film-coated pellets/granules dosed based on body weight/age once daily (QD) by mouth for 8, 12, or 16 weeks depending on HCV genotype, cirrhosis status, and prior treatment experience in participants 3 to < 6 years of age |
| Measure Participants | 14 | 13 | 13 | 12 |
| Geometric Mean (95% Confidence Interval) [L/h] |
62.6
|
31.8
|
29.1
|
19.9
|
| Title | Maximum Plasma Concentration (Cmax) of Pibrentasvir (PIB) at Week 2 |
|---|---|
| Description | Cmax is the peak concentration that a drug or drug metabolite achieves in a specified compartment after the drug has been administered and before administration of a second dose. It was estimated by non-compartmental pharmacokinetic analysis. |
| Time Frame | At Week 2 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Part 1 participants with intensive pharmacokinetic (IPK) sampling in Part 1 (3 participants were excluded due to abnormally low values at the Week 2 visit) and Part 2 participants with IPK sampling in Part 2 following the final proposed dosing regimen (1 participant in Cohort 4 received 200/80 mg dose [weight > 20kg] and was summarized in Cohort 3 based on actual dose received) |
| Arm/Group Title | Cohort 1: Adult Formulation GLE/PIB, Participants 12 to < 18 Yrs | Cohort 2: Pediatric Formulation GLE/PIB, Participants 9 to < 12 Yrs | Cohort 3: Pediatric Formulation GLE/PIB, Participants 6 to < 9 Yrs | Cohort 4: Pediatric Formulation GLE/PIB, Participants 3 to < 6 Yrs |
|---|---|---|---|---|
| Arm/Group Description | Adult formulation of glecaprevir (GLE)/pibrentasvir (PIB) 300 mg/120 mg co-formulated film-coated tablets once daily (QD) by mouth for 8, 12, or 16 weeks depending on hepatitis C virus (HCV) genotype, cirrhosis status, and prior treatment experience in participants 12 to < 18 years of age | Pediatric formulation of separate glecaprevir (GLE)/pibrentasvir (PIB)15.67% and 8.25% film-coated pellets/granules dosed based on body weight/age once daily (QD) by mouth for 8, 12, or 16 weeks depending on HCV genotype, cirrhosis status, and prior treatment experience in participants 9 to < 12 years of age | Pediatric formulation of separate glecaprevir (GLE)/pibrentasvir (PIB)15.67% and 8.25% film-coated pellets/granules dosed based on body weight/age once daily (QD) by mouth for 8, 12, or 16 weeks depending on HCV genotype, cirrhosis status, and prior treatment experience in participants 6 to < 9 years of age | Pediatric formulation of separate glecaprevir (GLE)/pibrentasvir (PIB)15.67% and 8.25% film-coated pellets/granules dosed based on body weight/age once daily (QD) by mouth for 8, 12, or 16 weeks depending on HCV genotype, cirrhosis status, and prior treatment experience in participants 3 to < 6 years of age |
| Measure Participants | 14 | 13 | 13 | 12 |
| Geometric Mean (95% Confidence Interval) [ng/mL] |
174
|
225
|
197
|
233
|
| Title | Clearance (CL) of Pibrentasvir (PIB) From Plasma at Week 2 |
|---|---|
| Description | CL is a quantitative measure of the rate at which a drug substance is removed from the body. It was estimated by non-compartmental pharmacokinetic analysis. |
| Time Frame | At Week 2 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Part 1 participants with intensive pharmacokinetic (IPK) sampling in Part 1 (3 participants were excluded due to abnormally low values at the Week 2 visit) and Part 2 participants with IPK sampling in Part 2 following the final proposed dosing regimen (1 participant in Cohort 4 received 200/80 mg dose [weight > 20kg] and was summarized in Cohort 3 based on actual dose received) |
| Arm/Group Title | Cohort 1: Adult Formulation GLE/PIB, Participants 12 to < 18 Yrs | Cohort 2: Pediatric Formulation GLE/PIB, Participants 9 to < 12 Yrs | Cohort 3: Pediatric Formulation GLE/PIB, Participants 6 to < 9 Yrs | Cohort 4: Pediatric Formulation GLE/PIB, Participants 3 to < 6 Yrs |
|---|---|---|---|---|
| Arm/Group Description | Adult formulation of glecaprevir (GLE)/pibrentasvir (PIB) 300 mg/120 mg co-formulated film-coated tablets once daily (QD) by mouth for 8, 12, or 16 weeks depending on hepatitis C virus (HCV) genotype, cirrhosis status, and prior treatment experience in participants 12 to < 18 years of age | Pediatric formulation of separate glecaprevir (GLE)/pibrentasvir (PIB)15.67% and 8.25% film-coated pellets/granules dosed based on body weight/age once daily (QD) by mouth for 8, 12, or 16 weeks depending on HCV genotype, cirrhosis status, and prior treatment experience in participants 9 to < 12 years of age | Pediatric formulation of separate glecaprevir (GLE)/pibrentasvir (PIB)15.67% and 8.25% film-coated pellets/granules dosed based on body weight/age once daily (QD) by mouth for 8, 12, or 16 weeks depending on HCV genotype, cirrhosis status, and prior treatment experience in participants 6 to < 9 years of age | Pediatric formulation of separate glecaprevir (GLE)/pibrentasvir (PIB)15.67% and 8.25% film-coated pellets/granules dosed based on body weight/age once daily (QD) by mouth for 8, 12, or 16 weeks depending on HCV genotype, cirrhosis status, and prior treatment experience in participants 3 to < 6 years of age |
| Measure Participants | 14 | 13 | 13 | 12 |
| Geometric Mean (95% Confidence Interval) [L/h] |
86.9
|
45.4
|
48.7
|
33.6
|
| Title | Percentage of Participants Who Experienced On-treatment Virologic Failure |
|---|---|
| Description | On-treatment virologic failure is defined as hepatitis C virus ribonucleic acid (HCV RNA) confirmed increase of > 1 (subscript)10(subscript) IU/mL above nadir during treatment, confirmed HCV RNA ≥ 100 IU/mL after HCV RNA < lower limit of quantification (LLOQ) during treatment, or HCV RNA ≥ LLOQ at the end of treatment with at least 6 weeks of treatment. |
| Time Frame | Up to Week 8, 12, or 16 (depending on treatment duration) |
Outcome Measure Data
| Analysis Population Description |
|---|
| Intention-to-treat (ITT population): all participants who received at least 1 dose of study drug |
| Arm/Group Title | Cohort 1: Adult Formulation GLE/PIB, Participants 12 to < 18 Yrs | Cohort 2: Pediatric Formulation GLE/PIB, Participants 9 to < 12 Yrs | Cohort 3: Pediatric Formulation GLE/PIB, Participants 6 to < 9 Yrs | Cohort 4: Pediatric Formulation GLE/PIB, Participants 3 to < 6 Yrs | Cohorts 2- 4: Pediatric Formulation GLE/PIB, Participants 3 to < 12 Yrs | Participants in Cohorts 1, 2, 3, and 4 |
|---|---|---|---|---|---|---|
| Arm/Group Description | Adult formulation of glecaprevir (GLE)/pibrentasvir (PIB) 300 mg/120 mg co-formulated film-coated tablets once daily (QD) by mouth for 8, 12, or 16 weeks depending on hepatitis C virus (HCV) genotype, cirrhosis status, and prior treatment experience in participants 12 to < 18 years of age | Pediatric formulation of separate glecaprevir (GLE)/pibrentasvir (PIB)15.67% and 8.25% film-coated pellets/granules dosed based on body weight/age once daily (QD) by mouth for 8, 12, or 16 weeks depending on HCV genotype, cirrhosis status, and prior treatment experience in participants 9 to < 12 years of age | Pediatric formulation of separate glecaprevir (GLE)/pibrentasvir (PIB)15.67% and 8.25% film-coated pellets/granules dosed based on body weight/age once daily (QD) by mouth for 8, 12, or 16 weeks depending on HCV genotype, cirrhosis status, and prior treatment experience in participants 6 to < 9 years of age | Pediatric formulation of separate glecaprevir (GLE)/pibrentasvir (PIB)15.67% and 8.25% film-coated pellets/granules dosed based on body weight/age once daily (QD) by mouth for 8, 12, or 16 weeks depending on HCV genotype, cirrhosis status, and prior treatment experience in participants 3 to < 6 years of age | Pediatric formulation of separate glecaprevir (GLE)/pibrentasvir (PIB) 15.67% and 8.25% film-coated pellets/granules dosed based on body weight/age once daily (QD) by mouth for 8, 12, or 16 weeks depending on HCV genotype, cirrhosis status, and prior treatment experience in participants 3 to < 12 years of age | Participants who received at least 1 dose of study drug |
| Measure Participants | 47 | 29 | 27 | 24 | 80 | 127 |
| Number (95% Confidence Interval) [percentage of participants] |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
NaN
|
| Title | Percentage of Participants With Post-treatment Relapse |
|---|---|
| Description | Post-treatment relapse is defined as confirmed hepatitis C virus ribonucleic acid (HCV RNA) ≥ the lower limit of quantification (LLOQ) between the end of treatment and 12 weeks after the last dose of study drug among participants who completed treatment as planned with HCV RNA < LLOQ at the end of treatment; excluding participants who had been shown to be re-infected. |
| Time Frame | Up to 12 weeks after the last dose of study drug (Week 20, 24, or 28 depending on treatment duration) |
Outcome Measure Data
| Analysis Population Description |
|---|
| Participants in ITT population with HCV RNA < LLOQ at the final treatment visit who completed treatment (based on study drug duration) and had post-treatment HCV RNA data, excluding participants with HCV re-infection |
| Arm/Group Title | Cohort 1: Adult Formulation GLE/PIB, Participants 12 to < 18 Yrs | Cohort 2: Pediatric Formulation GLE/PIB, Participants 9 to < 12 Yrs | Cohort 3: Pediatric Formulation GLE/PIB, Participants 6 to < 9 Yrs | Cohort 4: Pediatric Formulation GLE/PIB, Participants 3 to < 6 Yrs | Cohorts 2- 4: Pediatric Formulation GLE/PIB, Participants 3 to < 12 Yrs | Participants in Cohorts 1, 2, 3, and 4 |
|---|---|---|---|---|---|---|
| Arm/Group Description | Adult formulation of glecaprevir (GLE)/pibrentasvir (PIB) 300 mg/120 mg co-formulated film-coated tablets once daily (QD) by mouth for 8, 12, or 16 weeks depending on hepatitis C virus (HCV) genotype, cirrhosis status, and prior treatment experience in participants 12 to < 18 years of age | Pediatric formulation of separate glecaprevir (GLE)/pibrentasvir (PIB)15.67% and 8.25% film-coated pellets/granules dosed based on body weight/age once daily (QD) by mouth for 8, 12, or 16 weeks depending on HCV genotype, cirrhosis status, and prior treatment experience in participants 9 to < 12 years of age | Pediatric formulation of separate glecaprevir (GLE)/pibrentasvir (PIB)15.67% and 8.25% film-coated pellets/granules dosed based on body weight/age once daily (QD) by mouth for 8, 12, or 16 weeks depending on HCV genotype, cirrhosis status, and prior treatment experience in participants 6 to < 9 years of age | Pediatric formulation of separate glecaprevir (GLE)/pibrentasvir (PIB)15.67% and 8.25% film-coated pellets/granules dosed based on body weight/age once daily (QD) by mouth for 8, 12, or 16 weeks depending on HCV genotype, cirrhosis status, and prior treatment experience in participants 3 to < 6 years of age | Pediatric formulation of separate glecaprevir (GLE)/pibrentasvir (PIB) 15.67% and 8.25% film-coated pellets/granules dosed based on body weight/age once daily (QD) by mouth for 8, 12, or 16 weeks depending on HCV genotype, cirrhosis status, and prior treatment experience in participants 3 to < 12 years of age | Participants who received at least 1 dose of study drug |
| Measure Participants | 47 | 28 | 27 | 23 | 78 | 125 |
| Number (95% Confidence Interval) [percentage of participants] |
0
0%
|
3.6
12.4%
|
0
0%
|
0
0%
|
1.3
1%
|
0.8
NaN
|
| Title | Percentage of Participants With New Hepatitis C Virus (HCV) Infection (i.e., Reinfection) |
|---|---|
| Description | Reinfection is defined as confirmed hepatitis C virus ribonucleic acid (HCV RNA) ≥ the lower limit of quantification (LLOQ) in the post-treatment period along with post-treatment detection of a different HCV genotype, subtype, or clade compared with baseline. |
| Time Frame | Up to 12 weeks after last dose of study drug (Week 20, 24, or 28 depending on treatment duration) |
Outcome Measure Data
| Analysis Population Description |
|---|
| Intention-to-treat (ITT population): all participants who received at least 1 dose of study drug |
| Arm/Group Title | Cohort 1: Adult Formulation GLE/PIB, Participants 12 to < 18 Yrs | Cohort 2: Pediatric Formulation GLE/PIB, Participants 9 to < 12 Yrs | Cohort 3: Pediatric Formulation GLE/PIB, Participants 6 to < 9 Yrs | Cohort 4: Pediatric Formulation GLE/PIB, Participants 3 to < 6 Yrs | Cohorts 2- 4: Pediatric Formulation GLE/PIB, Participants 3 to < 12 Yrs | Participants in Cohorts 1, 2, 3, and 4 |
|---|---|---|---|---|---|---|
| Arm/Group Description | Adult formulation of glecaprevir (GLE)/pibrentasvir (PIB) 300 mg/120 mg co-formulated film-coated tablets once daily (QD) by mouth for 8, 12, or 16 weeks depending on hepatitis C virus (HCV) genotype, cirrhosis status, and prior treatment experience in participants 12 to < 18 years of age | Pediatric formulation of separate glecaprevir (GLE)/pibrentasvir (PIB)15.67% and 8.25% film-coated pellets/granules dosed based on body weight/age once daily (QD) by mouth for 8, 12, or 16 weeks depending on HCV genotype, cirrhosis status, and prior treatment experience in participants 9 to < 12 years of age | Pediatric formulation of separate glecaprevir (GLE)/pibrentasvir (PIB)15.67% and 8.25% film-coated pellets/granules dosed based on body weight/age once daily (QD) by mouth for 8, 12, or 16 weeks depending on HCV genotype, cirrhosis status, and prior treatment experience in participants 6 to < 9 years of age | Pediatric formulation of separate glecaprevir (GLE)/pibrentasvir (PIB)15.67% and 8.25% film-coated pellets/granules dosed based on body weight/age once daily (QD) by mouth for 8, 12, or 16 weeks depending on HCV genotype, cirrhosis status, and prior treatment experience in participants 3 to < 6 years of age | Pediatric formulation of separate glecaprevir (GLE)/pibrentasvir (PIB) 15.67% and 8.25% film-coated pellets/granules dosed based on body weight/age once daily (QD) by mouth for 8, 12, or 16 weeks depending on HCV genotype, cirrhosis status, and prior treatment experience in participants 3 to < 12 years of age | Participants who received at least 1 dose of study drug |
| Measure Participants | 47 | 29 | 27 | 24 | 80 | 127 |
| Number (95% Confidence Interval) [percentage of participants] |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
NaN
|
| Title | Palatability Questionnaire Question 1: How Convenient or Inconvenient Was it to Prepare the Dose? |
|---|---|
| Description | For each participant who received the pediatric formulation (Cohorts 2 - 4), the parent(s)/guardian(s) completed a Palatability Questionnaire to provide feedback on the perception of the dosage form. The Palatability Questionnaire included 6 questions related to the administration and ingestion of the pediatric GLE/PIB formulation. |
| Time Frame | At the End of Treatment visit or at the premature discontinuation visit (up to 8, 12, or 16 weeks, depending on treatment duration) |
Outcome Measure Data
| Analysis Population Description |
|---|
| Intention-to-treat population: participants who received at least one dose of the pediatric GLE/PIB formulation with available data |
| Arm/Group Title | Cohort 2: Pediatric Formulation GLE/PIB, Participants 9 to < 12 Yrs | Cohort 3: Pediatric Formulation GLE/PIB, Participants 6 to < 9 Yrs | Cohort 4: Pediatric Formulation GLE/PIB, Participants 3 to < 6 Yrs | Cohorts 2- 4: Pediatric Formulation GLE/PIB, Participants 3 to < 12 Yrs |
|---|---|---|---|---|
| Arm/Group Description | Pediatric formulation of separate glecaprevir (GLE)/pibrentasvir (PIB)15.67% and 8.25% film-coated pellets/granules dosed based on body weight/age once daily (QD) by mouth for 8, 12, or 16 weeks depending on HCV genotype, cirrhosis status, and prior treatment experience in participants 9 to < 12 years of age | Pediatric formulation of separate glecaprevir (GLE)/pibrentasvir (PIB)15.67% and 8.25% film-coated pellets/granules dosed based on body weight/age once daily (QD) by mouth for 8, 12, or 16 weeks depending on HCV genotype, cirrhosis status, and prior treatment experience in participants 6 to < 9 years of age | Pediatric formulation of separate glecaprevir (GLE)/pibrentasvir (PIB)15.67% and 8.25% film-coated pellets/granules dosed based on body weight/age once daily (QD) by mouth for 8, 12, or 16 weeks depending on HCV genotype, cirrhosis status, and prior treatment experience in participants 3 to < 6 years of age | Pediatric formulation of separate glecaprevir (GLE)/pibrentasvir (PIB) 15.67% and 8.25% film-coated pellets/granules dosed based on body weight/age once daily (QD) by mouth for 8, 12, or 16 weeks depending on HCV genotype, cirrhosis status, and prior treatment experience in participants 3 to < 12 years of age |
| Measure Participants | 28 | 27 | 23 | 78 |
| Very convenient |
7
14.9%
|
9
31%
|
9
33.3%
|
25
104.2%
|
| Convenient |
13
27.7%
|
10
34.5%
|
8
29.6%
|
31
129.2%
|
| Borderline |
2
4.3%
|
7
24.1%
|
4
14.8%
|
13
54.2%
|
| Inconvenient |
6
12.8%
|
1
3.4%
|
1
3.7%
|
8
33.3%
|
| Very inconvenient |
0
0%
|
0
0%
|
1
3.7%
|
1
4.2%
|
| Title | Palatability Questionnaire Question 2: How Long Did it Typically Take for the Child to Take the Dose? |
|---|---|
| Description | For each participant who received the pediatric formulation (Cohorts 2 - 4), the parent(s)/guardian(s) completed a Palatability Questionnaire to provide feedback on the perception of the dosage form. The Palatability Questionnaire included 6 questions related to the administration and ingestion of the pediatric GLE/PIB formulation. |
| Time Frame | At the End of Treatment visit or at the premature discontinuation visit (up to 8, 12, or 16 weeks, depending on treatment duration) |
Outcome Measure Data
| Analysis Population Description |
|---|
| Intention-to-treat population: participants who received at least one dose of the pediatric GLE/PIB formulation with available data |
| Arm/Group Title | Cohort 2: Pediatric Formulation GLE/PIB, Participants 9 to < 12 Yrs | Cohort 3: Pediatric Formulation GLE/PIB, Participants 6 to < 9 Yrs | Cohort 4: Pediatric Formulation GLE/PIB, Participants 3 to < 6 Yrs | Cohorts 2- 4: Pediatric Formulation GLE/PIB, Participants 3 to < 12 Yrs |
|---|---|---|---|---|
| Arm/Group Description | Pediatric formulation of separate glecaprevir (GLE)/pibrentasvir (PIB)15.67% and 8.25% film-coated pellets/granules dosed based on body weight/age once daily (QD) by mouth for 8, 12, or 16 weeks depending on HCV genotype, cirrhosis status, and prior treatment experience in participants 9 to < 12 years of age | Pediatric formulation of separate glecaprevir (GLE)/pibrentasvir (PIB)15.67% and 8.25% film-coated pellets/granules dosed based on body weight/age once daily (QD) by mouth for 8, 12, or 16 weeks depending on HCV genotype, cirrhosis status, and prior treatment experience in participants 6 to < 9 years of age | Pediatric formulation of separate glecaprevir (GLE)/pibrentasvir (PIB)15.67% and 8.25% film-coated pellets/granules dosed based on body weight/age once daily (QD) by mouth for 8, 12, or 16 weeks depending on HCV genotype, cirrhosis status, and prior treatment experience in participants 3 to < 6 years of age | Pediatric formulation of separate glecaprevir (GLE)/pibrentasvir (PIB) 15.67% and 8.25% film-coated pellets/granules dosed based on body weight/age once daily (QD) by mouth for 8, 12, or 16 weeks depending on HCV genotype, cirrhosis status, and prior treatment experience in participants 3 to < 12 years of age |
| Measure Participants | 28 | 27 | 23 | 78 |
| 5 minutes or less |
22
46.8%
|
23
79.3%
|
21
77.8%
|
66
275%
|
| 5 to 15 minutes |
5
10.6%
|
4
13.8%
|
2
7.4%
|
11
45.8%
|
| 15 to 30 minutes |
1
2.1%
|
0
0%
|
0
0%
|
1
4.2%
|
| More than 30 minutes |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Title | Palatability Questionnaire Question 3: Were You Able to Successfully Administer the Whole Dose to the Child With 1 to 2 Teaspoons (5 to 10 mL) of Soft Food? |
|---|---|
| Description | For each participant who received the pediatric formulation (Cohorts 2 - 4), the parent(s)/guardian(s) completed a Palatability Questionnaire to provide feedback on the perception of the dosage form. The Palatability Questionnaire included 6 questions related to the administration and ingestion of the pediatric GLE/PIB formulation. |
| Time Frame | At the End of Treatment visit or at the premature discontinuation visit (up to 8, 12, or 16 weeks, depending on treatment duration) |
Outcome Measure Data
| Analysis Population Description |
|---|
| Intention-to-treat population: participants who received at least one dose of the pediatric GLE/PIB formulation with available data |
| Arm/Group Title | Cohort 2: Pediatric Formulation GLE/PIB, Participants 9 to < 12 Yrs | Cohort 3: Pediatric Formulation GLE/PIB, Participants 6 to < 9 Yrs | Cohort 4: Pediatric Formulation GLE/PIB, Participants 3 to < 6 Yrs | Cohorts 2- 4: Pediatric Formulation GLE/PIB, Participants 3 to < 12 Yrs |
|---|---|---|---|---|
| Arm/Group Description | Pediatric formulation of separate glecaprevir (GLE)/pibrentasvir (PIB)15.67% and 8.25% film-coated pellets/granules dosed based on body weight/age once daily (QD) by mouth for 8, 12, or 16 weeks depending on HCV genotype, cirrhosis status, and prior treatment experience in participants 9 to < 12 years of age | Pediatric formulation of separate glecaprevir (GLE)/pibrentasvir (PIB)15.67% and 8.25% film-coated pellets/granules dosed based on body weight/age once daily (QD) by mouth for 8, 12, or 16 weeks depending on HCV genotype, cirrhosis status, and prior treatment experience in participants 6 to < 9 years of age | Pediatric formulation of separate glecaprevir (GLE)/pibrentasvir (PIB)15.67% and 8.25% film-coated pellets/granules dosed based on body weight/age once daily (QD) by mouth for 8, 12, or 16 weeks depending on HCV genotype, cirrhosis status, and prior treatment experience in participants 3 to < 6 years of age | Pediatric formulation of separate glecaprevir (GLE)/pibrentasvir (PIB) 15.67% and 8.25% film-coated pellets/granules dosed based on body weight/age once daily (QD) by mouth for 8, 12, or 16 weeks depending on HCV genotype, cirrhosis status, and prior treatment experience in participants 3 to < 12 years of age |
| Measure Participants | 28 | 27 | 23 | 78 |
| Yes |
20
42.6%
|
19
65.5%
|
19
70.4%
|
58
241.7%
|
| No |
8
17%
|
8
27.6%
|
3
11.1%
|
19
79.2%
|
| Missing data |
0
0%
|
0
0%
|
1
3.7%
|
1
4.2%
|
| Title | Palatability Questionnaire Question 4: Did You Experience Any Resistance When Feeding the Child the Medicine? |
|---|---|
| Description | For each participant who received the pediatric formulation (Cohorts 2 - 4), the parent(s)/guardian(s) completed a Palatability Questionnaire to provide feedback on the perception of the dosage form. The Palatability Questionnaire included 6 questions related to the administration and ingestion of the pediatric GLE/PIB formulation. |
| Time Frame | At the End of Treatment visit or at the premature discontinuation visit (up to 8, 12, or 16 weeks, depending on treatment duration) |
Outcome Measure Data
| Analysis Population Description |
|---|
| Intention-to-treat population: participants who received at least one dose of the pediatric GLE/PIB formulation with available data |
| Arm/Group Title | Cohort 2: Pediatric Formulation GLE/PIB, Participants 9 to < 12 Yrs | Cohort 3: Pediatric Formulation GLE/PIB, Participants 6 to < 9 Yrs | Cohort 4: Pediatric Formulation GLE/PIB, Participants 3 to < 6 Yrs | Cohorts 2- 4: Pediatric Formulation GLE/PIB, Participants 3 to < 12 Yrs |
|---|---|---|---|---|
| Arm/Group Description | Pediatric formulation of separate glecaprevir (GLE)/pibrentasvir (PIB)15.67% and 8.25% film-coated pellets/granules dosed based on body weight/age once daily (QD) by mouth for 8, 12, or 16 weeks depending on HCV genotype, cirrhosis status, and prior treatment experience in participants 9 to < 12 years of age | Pediatric formulation of separate glecaprevir (GLE)/pibrentasvir (PIB)15.67% and 8.25% film-coated pellets/granules dosed based on body weight/age once daily (QD) by mouth for 8, 12, or 16 weeks depending on HCV genotype, cirrhosis status, and prior treatment experience in participants 6 to < 9 years of age | Pediatric formulation of separate glecaprevir (GLE)/pibrentasvir (PIB)15.67% and 8.25% film-coated pellets/granules dosed based on body weight/age once daily (QD) by mouth for 8, 12, or 16 weeks depending on HCV genotype, cirrhosis status, and prior treatment experience in participants 3 to < 6 years of age | Pediatric formulation of separate glecaprevir (GLE)/pibrentasvir (PIB) 15.67% and 8.25% film-coated pellets/granules dosed based on body weight/age once daily (QD) by mouth for 8, 12, or 16 weeks depending on HCV genotype, cirrhosis status, and prior treatment experience in participants 3 to < 12 years of age |
| Measure Participants | 28 | 27 | 23 | 78 |
| Yes |
6
12.8%
|
4
13.8%
|
7
25.9%
|
17
70.8%
|
| No |
22
46.8%
|
23
79.3%
|
15
55.6%
|
60
250%
|
| Missing data |
0
0%
|
0
0%
|
1
3.7%
|
1
4.2%
|
| Title | Palatability Questionnaire Question 4a: Type of Feeding Resistance |
|---|---|
| Description | For each participant who received the pediatric formulation (Cohorts 2 - 4), the parent(s)/guardian(s) completed a Palatability Questionnaire to provide feedback on the perception of the dosage form. The Palatability Questionnaire included 6 questions related to the administration and ingestion of the pediatric GLE/PIB formulation. |
| Time Frame | At the End of Treatment visit or at the premature discontinuation visit (up to 8, 12, or 16 weeks, depending on treatment duration) |
Outcome Measure Data
| Analysis Population Description |
|---|
| Intention-to-treat population: participants who received at least one dose of the pediatric GLE/PIB formulation with available data who answered "Yes" to question 4 of the Palatability Questionnaire |
| Arm/Group Title | Cohort 2: Pediatric Formulation GLE/PIB, Participants 9 to < 12 Yrs | Cohort 3: Pediatric Formulation GLE/PIB, Participants 6 to < 9 Yrs | Cohort 4: Pediatric Formulation GLE/PIB, Participants 3 to < 6 Yrs | Cohorts 2- 4: Pediatric Formulation GLE/PIB, Participants 3 to < 12 Yrs |
|---|---|---|---|---|
| Arm/Group Description | Pediatric formulation of separate glecaprevir (GLE)/pibrentasvir (PIB)15.67% and 8.25% film-coated pellets/granules dosed based on body weight/age once daily (QD) by mouth for 8, 12, or 16 weeks depending on HCV genotype, cirrhosis status, and prior treatment experience in participants 9 to < 12 years of age | Pediatric formulation of separate glecaprevir (GLE)/pibrentasvir (PIB)15.67% and 8.25% film-coated pellets/granules dosed based on body weight/age once daily (QD) by mouth for 8, 12, or 16 weeks depending on HCV genotype, cirrhosis status, and prior treatment experience in participants 6 to < 9 years of age | Pediatric formulation of separate glecaprevir (GLE)/pibrentasvir (PIB)15.67% and 8.25% film-coated pellets/granules dosed based on body weight/age once daily (QD) by mouth for 8, 12, or 16 weeks depending on HCV genotype, cirrhosis status, and prior treatment experience in participants 3 to < 6 years of age | Pediatric formulation of separate glecaprevir (GLE)/pibrentasvir (PIB) 15.67% and 8.25% film-coated pellets/granules dosed based on body weight/age once daily (QD) by mouth for 8, 12, or 16 weeks depending on HCV genotype, cirrhosis status, and prior treatment experience in participants 3 to < 12 years of age |
| Measure Participants | 6 | 4 | 7 | 17 |
| Did not like taste of medicine |
3
6.4%
|
5
17.2%
|
6
22.2%
|
14
58.3%
|
| Did not like texture of medicine |
2
4.3%
|
2
6.9%
|
5
18.5%
|
9
37.5%
|
| Did not like the soft food used |
3
6.4%
|
2
6.9%
|
0
0%
|
5
20.8%
|
| Did not like to swallow the amount of medicine |
3
6.4%
|
2
6.9%
|
3
11.1%
|
8
33.3%
|
| Unrelated to the medicine |
0
0%
|
0
0%
|
1
3.7%
|
1
4.2%
|
| Title | Palatability Questionnaire Question 5: How Easy or Difficult Was it for the Child to Swallow the Medicine? |
|---|---|
| Description | For each participant who received the pediatric formulation (Cohorts 2 - 4), the parent(s)/guardian(s) completed a Palatability Questionnaire to provide feedback on the perception of the dosage form. The Palatability Questionnaire included 6 questions related to the administration and ingestion of the pediatric GLE/PIB formulation. |
| Time Frame | At the End of Treatment visit or at the premature discontinuation visit (up to 8, 12, or 16 weeks, depending on treatment duration) |
Outcome Measure Data
| Analysis Population Description |
|---|
| Intention-to-treat population: participants who received at least one dose of the pediatric GLE/PIB formulation with available data |
| Arm/Group Title | Cohort 2: Pediatric Formulation GLE/PIB, Participants 9 to < 12 Yrs | Cohort 3: Pediatric Formulation GLE/PIB, Participants 6 to < 9 Yrs | Cohort 4: Pediatric Formulation GLE/PIB, Participants 3 to < 6 Yrs | Cohorts 2- 4: Pediatric Formulation GLE/PIB, Participants 3 to < 12 Yrs |
|---|---|---|---|---|
| Arm/Group Description | Pediatric formulation of separate glecaprevir (GLE)/pibrentasvir (PIB)15.67% and 8.25% film-coated pellets/granules dosed based on body weight/age once daily (QD) by mouth for 8, 12, or 16 weeks depending on HCV genotype, cirrhosis status, and prior treatment experience in participants 9 to < 12 years of age | Pediatric formulation of separate glecaprevir (GLE)/pibrentasvir (PIB)15.67% and 8.25% film-coated pellets/granules dosed based on body weight/age once daily (QD) by mouth for 8, 12, or 16 weeks depending on HCV genotype, cirrhosis status, and prior treatment experience in participants 6 to < 9 years of age | Pediatric formulation of separate glecaprevir (GLE)/pibrentasvir (PIB)15.67% and 8.25% film-coated pellets/granules dosed based on body weight/age once daily (QD) by mouth for 8, 12, or 16 weeks depending on HCV genotype, cirrhosis status, and prior treatment experience in participants 3 to < 6 years of age | Pediatric formulation of separate glecaprevir (GLE)/pibrentasvir (PIB) 15.67% and 8.25% film-coated pellets/granules dosed based on body weight/age once daily (QD) by mouth for 8, 12, or 16 weeks depending on HCV genotype, cirrhosis status, and prior treatment experience in participants 3 to < 12 years of age |
| Measure Participants | 28 | 27 | 23 | 78 |
| Very easy |
10
21.3%
|
8
27.6%
|
11
40.7%
|
29
120.8%
|
| Easy |
13
27.7%
|
16
55.2%
|
10
37%
|
39
162.5%
|
| Borderline |
4
8.5%
|
3
10.3%
|
1
3.7%
|
8
33.3%
|
| Difficult |
1
2.1%
|
0
0%
|
0
0%
|
1
4.2%
|
| Very difficult |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Missing data |
0
0%
|
0
0%
|
1
3.7%
|
1
4.2%
|
Adverse Events
| Time Frame | Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until 30 days after last study drug administration, up to 20 weeks. In addition, serious adverse events and protocol-related nonserious adverse events were collected from the time the participant signed the study-specific informed consent. | |||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Adverse Event Reporting Description | TEAEs and SAEs are defined as any AE or SAE with onset or worsening reported by a participant from the time that the first dose of study drug is administered until 30 days have elapsed following discontinuation of study drug. TEAEs were collected whether elicited or spontaneously reported by the participant. | |||||||||||
| Arm/Group Title | Cohort 1: Adult Formulation GLE/PIB, Participants 12 to < 18 Yrs | Cohort 2: Pediatric Formulation GLE/PIB, Participants 9 to < 12 Yrs | Cohort 3: Pediatric Formulation GLE/PIB, Participants 6 to < 9 Yrs | Cohort 4: Pediatric Formulation GLE/PIB, Participants 3 to < 6 Yrs | Cohorts 2- 4: Pediatric Formulation GLE/PIB, Participants 3 to < 12 Yrs | Participants in Cohorts 1, 2, 3, and 4 | ||||||
| Arm/Group Description | Adult formulation glecaprevir (GLE)/pibrentasvir (PIB) 300 mg/120 mg co-formulated film-coated tablets once daily (QD) by mouth for 8, 12, or 16 weeks depending on hepatitis C virus (HCV) genotype, cirrhosis status, and prior treatment experience in participants 12 to < 18 years of age | Pediatric formulation of separate glecaprevir (GLE)/pibrentasvir (PIB) 15.67% and 8.25% film-coated pellets/granules dosed based on body weight/age once daily (QD) by mouth for 8, 12, or 16 weeks depending on HCV genotype, cirrhosis status, and prior treatment experience in participants 9 to < 12 years of age | Pediatric formulation of separate glecaprevir (GLE)/pibrentasvir (PIB) 15.67% and 8.25% film-coated pellets/granules dosed based on body weight/age once daily (QD) by mouth for 8, 12, or 16 weeks depending on HCV genotype, cirrhosis status, and prior treatment experience in participants 6 to < 9 years of age | Pediatric formulation of separate glecaprevir (GLE)/pibrentasvir (PIB) 15.67% and 8.25% film-coated pellets/granules dosed based on body weight/age once daily (QD) by mouth for 8, 12, or 16 weeks depending on HCV genotype, cirrhosis status, and prior treatment experience in participants 3 to < 6 years of age | Pediatric formulation of separate glecaprevir (GLE)/pibrentasvir (PIB) 15.67% and 8.25% film-coated pellets/granules dosed based on body weight/age once daily (QD) by mouth for 8, 12, or 16 weeks depending on HCV genotype, cirrhosis status, and prior treatment experience in participants 3 to < 12 years of age | Participants who received at least 1 dose of study drug | ||||||
All Cause Mortality |
||||||||||||
| Cohort 1: Adult Formulation GLE/PIB, Participants 12 to < 18 Yrs | Cohort 2: Pediatric Formulation GLE/PIB, Participants 9 to < 12 Yrs | Cohort 3: Pediatric Formulation GLE/PIB, Participants 6 to < 9 Yrs | Cohort 4: Pediatric Formulation GLE/PIB, Participants 3 to < 6 Yrs | Cohorts 2- 4: Pediatric Formulation GLE/PIB, Participants 3 to < 12 Yrs | Participants in Cohorts 1, 2, 3, and 4 | |||||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/47 (0%) | 0/29 (0%) | 0/27 (0%) | 0/24 (0%) | 0/80 (0%) | 0/127 (0%) | ||||||
Serious Adverse Events |
||||||||||||
| Cohort 1: Adult Formulation GLE/PIB, Participants 12 to < 18 Yrs | Cohort 2: Pediatric Formulation GLE/PIB, Participants 9 to < 12 Yrs | Cohort 3: Pediatric Formulation GLE/PIB, Participants 6 to < 9 Yrs | Cohort 4: Pediatric Formulation GLE/PIB, Participants 3 to < 6 Yrs | Cohorts 2- 4: Pediatric Formulation GLE/PIB, Participants 3 to < 12 Yrs | Participants in Cohorts 1, 2, 3, and 4 | |||||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/47 (0%) | 0/29 (0%) | 0/27 (0%) | 0/24 (0%) | 0/80 (0%) | 0/127 (0%) | ||||||
Other (Not Including Serious) Adverse Events |
||||||||||||
| Cohort 1: Adult Formulation GLE/PIB, Participants 12 to < 18 Yrs | Cohort 2: Pediatric Formulation GLE/PIB, Participants 9 to < 12 Yrs | Cohort 3: Pediatric Formulation GLE/PIB, Participants 6 to < 9 Yrs | Cohort 4: Pediatric Formulation GLE/PIB, Participants 3 to < 6 Yrs | Cohorts 2- 4: Pediatric Formulation GLE/PIB, Participants 3 to < 12 Yrs | Participants in Cohorts 1, 2, 3, and 4 | |||||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 31/47 (66%) | 15/29 (51.7%) | 16/27 (59.3%) | 17/24 (70.8%) | 48/80 (60%) | 79/127 (62.2%) | ||||||
| Cardiac disorders | ||||||||||||
| PALPITATIONS | 0/47 (0%) | 0 | 0/29 (0%) | 0 | 2/27 (7.4%) | 2 | 0/24 (0%) | 0 | 2/80 (2.5%) | 2 | 2/127 (1.6%) | 2 |
| Ear and labyrinth disorders | ||||||||||||
| MOTION SICKNESS | 0/47 (0%) | 0 | 2/29 (6.9%) | 2 | 0/27 (0%) | 0 | 0/24 (0%) | 0 | 2/80 (2.5%) | 2 | 2/127 (1.6%) | 2 |
| Gastrointestinal disorders | ||||||||||||
| ABDOMINAL PAIN | 2/47 (4.3%) | 2 | 2/29 (6.9%) | 2 | 1/27 (3.7%) | 1 | 0/24 (0%) | 0 | 3/80 (3.8%) | 3 | 5/127 (3.9%) | 5 |
| ABDOMINAL PAIN UPPER | 1/47 (2.1%) | 1 | 2/29 (6.9%) | 2 | 1/27 (3.7%) | 1 | 2/24 (8.3%) | 3 | 5/80 (6.3%) | 6 | 6/127 (4.7%) | 7 |
| DIARRHOEA | 3/47 (6.4%) | 3 | 2/29 (6.9%) | 2 | 4/27 (14.8%) | 4 | 2/24 (8.3%) | 2 | 8/80 (10%) | 8 | 11/127 (8.7%) | 11 |
| NAUSEA | 4/47 (8.5%) | 4 | 2/29 (6.9%) | 2 | 2/27 (7.4%) | 2 | 1/24 (4.2%) | 1 | 5/80 (6.3%) | 5 | 9/127 (7.1%) | 9 |
| VOMITING | 5/47 (10.6%) | 5 | 1/29 (3.4%) | 1 | 6/27 (22.2%) | 6 | 4/24 (16.7%) | 4 | 11/80 (13.8%) | 11 | 16/127 (12.6%) | 16 |
| General disorders | ||||||||||||
| FATIGUE | 5/47 (10.6%) | 5 | 1/29 (3.4%) | 1 | 3/27 (11.1%) | 3 | 3/24 (12.5%) | 3 | 7/80 (8.8%) | 7 | 12/127 (9.4%) | 12 |
| PYREXIA | 5/47 (10.6%) | 6 | 2/29 (6.9%) | 2 | 2/27 (7.4%) | 3 | 2/24 (8.3%) | 2 | 6/80 (7.5%) | 7 | 11/127 (8.7%) | 13 |
| Infections and infestations | ||||||||||||
| LICE INFESTATION | 0/47 (0%) | 0 | 0/29 (0%) | 0 | 0/27 (0%) | 0 | 2/24 (8.3%) | 2 | 2/80 (2.5%) | 2 | 2/127 (1.6%) | 2 |
| NASOPHARYNGITIS | 11/47 (23.4%) | 12 | 4/29 (13.8%) | 4 | 1/27 (3.7%) | 1 | 1/24 (4.2%) | 1 | 6/80 (7.5%) | 6 | 17/127 (13.4%) | 18 |
| UPPER RESPIRATORY TRACT INFECTION | 9/47 (19.1%) | 11 | 1/29 (3.4%) | 1 | 3/27 (11.1%) | 5 | 2/24 (8.3%) | 2 | 6/80 (7.5%) | 8 | 15/127 (11.8%) | 19 |
| VIRAL INFECTION | 0/47 (0%) | 0 | 0/29 (0%) | 0 | 2/27 (7.4%) | 2 | 2/24 (8.3%) | 2 | 4/80 (5%) | 4 | 4/127 (3.1%) | 4 |
| Metabolism and nutrition disorders | ||||||||||||
| INCREASED APPETITE | 0/47 (0%) | 0 | 0/29 (0%) | 0 | 0/27 (0%) | 0 | 2/24 (8.3%) | 2 | 2/80 (2.5%) | 2 | 2/127 (1.6%) | 2 |
| Nervous system disorders | ||||||||||||
| HEADACHE | 8/47 (17%) | 12 | 2/29 (6.9%) | 2 | 6/27 (22.2%) | 6 | 3/24 (12.5%) | 3 | 11/80 (13.8%) | 11 | 19/127 (15%) | 23 |
| Respiratory, thoracic and mediastinal disorders | ||||||||||||
| COUGH | 2/47 (4.3%) | 2 | 1/29 (3.4%) | 1 | 1/27 (3.7%) | 1 | 5/24 (20.8%) | 6 | 7/80 (8.8%) | 8 | 9/127 (7.1%) | 10 |
| DYSPNOEA | 0/47 (0%) | 0 | 0/29 (0%) | 0 | 0/27 (0%) | 0 | 3/24 (12.5%) | 3 | 3/80 (3.8%) | 3 | 3/127 (2.4%) | 3 |
| NASAL CONGESTION | 4/47 (8.5%) | 4 | 0/29 (0%) | 0 | 0/27 (0%) | 0 | 0/24 (0%) | 0 | 0/80 (0%) | 0 | 4/127 (3.1%) | 4 |
| OROPHARYNGEAL PAIN | 5/47 (10.6%) | 5 | 2/29 (6.9%) | 2 | 1/27 (3.7%) | 1 | 0/24 (0%) | 0 | 3/80 (3.8%) | 3 | 8/127 (6.3%) | 8 |
| RHINORRHOEA | 0/47 (0%) | 0 | 0/29 (0%) | 0 | 0/27 (0%) | 0 | 2/24 (8.3%) | 2 | 2/80 (2.5%) | 2 | 2/127 (1.6%) | 2 |
| Skin and subcutaneous tissue disorders | ||||||||||||
| PRURITUS | 0/47 (0%) | 0 | 2/29 (6.9%) | 2 | 1/27 (3.7%) | 1 | 0/24 (0%) | 0 | 3/80 (3.8%) | 3 | 3/127 (2.4%) | 3 |
| RASH | 1/47 (2.1%) | 1 | 2/29 (6.9%) | 3 | 1/27 (3.7%) | 1 | 0/24 (0%) | 0 | 3/80 (3.8%) | 4 | 4/127 (3.1%) | 5 |
Limitations/Caveats
[Not Specified]
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
AbbVie requests that any investigator or institution that plans on presenting/publishing results disclosure, provide written notification of their request 60 days prior to their presentation/publication. AbbVie requests that no presentation/publication will be instituted until 12 months after a study is completed, or after the first presentation/publication whichever occurs first. A delay may be proposed of a presentation/publication if AbbVie needs to secure patent or proprietary protection.
Results Point of Contact
| Name/Title | Global Medical Services |
|---|---|
| Organization | AbbVie |
| Phone | 800-633-9110 |
| abbvieclinicaltrials@abbvie.com |
Responsible Party:
AbbVie
ClinicalTrials.gov Identifier:
NCT03067129
Other Study ID Numbers:
- M16-123
- 2016-004102-34
First Posted:
Mar 1, 2017
Last Update Posted:
Jun 23, 2022
Last Verified:
Jun 1, 2022