Navigator: A Study to Evaluate Paritaprevir With Ritonavir (ABT-450/r) When Given Together With Ombitasvir and With and Without Ribavirin (RBV) in Treatment-Naïve Participants With Genotype 1, 2 or 3 Chronic Hepatitis C Virus (HCV)
Sponsor
AbbVie (prior sponsor, Abbott) (Industry)
Overall Status
Completed
CT.gov ID
NCT01458535
Collaborator
(none)
61
6
20
Study Details
Study Description
Brief Summary
The purpose of this study was to evaluate the efficacy, safety and pharmacokinetics of ABT-450/r when given together with ABT-267 and with and without RBV in treatment-naïve participants with genotype 1, 2 or 3 chronic HCV infection.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 2 |
Detailed Description
This was a 2 sequential arm, combination treatment study where each arm contained 3 cohorts:
one each for HCV genotype 1, 2, and 3. The study consisted of 2 phases, a treatment phase and a post-treatment phase. The treatment phase was designed to explore the antiviral activity, safety and pharmacokinetics of ABT-450/r dosed in combination with ABT-267 with and without RBV for up to 12 weeks. The post-treatment phase was designed to monitor and evaluate Sustained Virologic Response (SVR) 12, SVR 24, and the evolution and persistence of viral resistance to ABT-267 and ABT-450 in HCV genotype 1-, 2-, and 3-infected participants who have been exposed to ABT-267 and ABT-450/r. Arms 1 and 2 were enrolled sequentially.
Study Design
Study Type:
Interventional
Actual Enrollment
:
61 participants
Allocation:
Non-Randomized
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
An Open-Label, Sequential Arm, Multicenter Study to Evaluate the Antiviral Activity, Safety and Pharmacokinetics of ABT-450 With Ritonavir (ABT-450/r) Dosed in Combination With ABT-267 With and Without Ribavirin (RBV) in Treatment-Naïve Subjects With Genotype 1, 2 or 3 Chronic Hepatitis C Virus (HCV) Infection
Study Start Date
:
Sep 1, 2011
Actual Primary Completion Date
:
May 1, 2013
Actual Study Completion Date
:
May 1, 2013
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: ABT-450/r and ABT-267 plus RBV in genotype 1 participants ABT-450/r (200/100 mg) once daily (QD) and ABT-267 (25 mg) QD plus weight-based ribavirin (RBV) divided twice daily (BID) in treatment-naïve participants with HCV genotype 1 infection. |
Drug: ABT-450
tablets
Other Names:
Drug: ABT-267
tablets
Other Names:
Drug: ribavirin
tablets
Drug: ritonavir
capsules
Other Names:
|
| Experimental: ABT-450/r and ABT-267 plus RBV in genotype 2 participants ABT-450/r (200/100 mg) once daily (QD) and ABT-267 (25 mg) QD plus weight-based ribavirin (RBV) divided BID in treatment-naïve participants with HCV genotype 2 infection. |
Drug: ABT-450
tablets
Other Names:
Drug: ABT-267
tablets
Other Names:
Drug: ribavirin
tablets
Drug: ritonavir
capsules
Other Names:
|
| Experimental: ABT-450/r and ABT-267 plus RBV in genotype 3 participants ABT-450/r (200/100 mg) once daily (QD) and ABT-267 (25 mg) QD plus weight-based ribavirin (RBV) divided BID in treatment-naïve participants with HCV genotype 3 infection. |
Drug: ABT-450
tablets
Other Names:
Drug: ABT-267
tablets
Other Names:
Drug: ribavirin
tablets
Drug: ritonavir
capsules
Other Names:
|
| Experimental: ABT-450/r and ABT-267 in genotype 1 participants ABT-450/r (200/100 mg) once daily (QD) and ABT-267 (25 mg) QD in treatment-naïve participants with HCV genotype 1 infection. |
Drug: ABT-450
tablets
Other Names:
Drug: ABT-267
tablets
Other Names:
Drug: ritonavir
capsules
Other Names:
|
| Experimental: ABT-450/r and ABT-267 in genotype 2 participants ABT-450/r (200/100 mg) once daily (QD) and ABT-267 (25 mg) QD in treatment-naïve participants with HCV genotype 2 infection. |
Drug: ABT-450
tablets
Other Names:
Drug: ABT-267
tablets
Other Names:
Drug: ritonavir
capsules
Other Names:
|
| Experimental: ABT-450/r and ABT-267 in genotype 3 participants ABT-450/r (200/100 mg) once daily (QD) and ABT-267 (25 mg) QD in treatment-naïve participants with HCV genotype 3 infection. |
Drug: ABT-450
tablets
Other Names:
Drug: ABT-267
tablets
Other Names:
Drug: ritonavir
capsules
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Percentage of Participants With Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Suppressed Below the Lower Limit of Quantitation (LLOQ) From Week 4 Through Week 12 [(Extended Rapid Virologic Response (eRVR)] [Week 4 through Week 12]
Analysis of the percentage of participants with hepatitis C virus ribonucleic acid less than the lower limit of quantitation (< 25 IU/mL). Participants with missing data were imputed as failures.
Secondary Outcome Measures
- Percentage of Participants With Sustained Virologic Response 12 Weeks (SVR12) Post-treatment [Post-treatment Day 1 to Post-treatment Week 12]
Sustained Virologic Response 12 (SVR12) is defined as plasma hepatitis C virus ribonucleic acid (HCV RNA) less than the lower limit of quantification (< LLOQ; < 25 IU/mL) 12 weeks after the last dose of study drug. Participants with missing data were imputed as failures.
- Percentage of Participants With Sustained Virologic Response 24 Weeks (SVR24) Post-Treatment [Post-treatment Day 1 to Post-treatment Week 24]
Sustained Virologic Response 24 (SVR24) is defined as plasma hepatitis C virus ribonucleic acid (HCV RNA) less than the lower limit of quantification (LLOQ; < 25 IU/mL) 24 weeks after the last dose of study drug. Participants with missing data were imputed as failures.
- Percentage of Participants With Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) < 1000 International Units Per Milliliter (IU/mL) [Week 2]
Analysis of participants with HCV RNA levels below 1000 IU/mL at Week 2. Participants with missing data were imputed as failures.
- Percentage of Participants With Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Below the Lower Limit of Quantitation (LLOQ) at Week 4 Rapid Virologic Response (RVR) [Week 4]
Analysis of percentage of participants with hepatitis C virus ribonucleic acid less than the lower limit of quantitation (< 25 IU/mL). Participants with missing data were imputed as failures.
- Percentage of Participants With Virologic Failure During Treatment [Day 1 through Week 12]
Virologic failure during treatment is defined as a participant meeting any virologic stopping criteria, including 1) rebound (defined as the first day of 2 consecutive increases of at least 0.5 log10 IU/mL above nadir (local minimum value), or first day of 2 consecutive HCV RNA >= LLOQ for participants who previously achieved HCV RNA < LLOQ) during treatment, 2) participant who fails to suppress (defined as never achieving HCV RNA < LLOQ during treatment).
- Percentage of Participants Who Experienced Virologic Relapse Through End of Post Treatment Period (up to 48 Weeks) [Post-treatment Day 1 to Post-treatment Week 48]
Virologic relapse is defined as confirmed hepatitis C virus (HCV) ribonucleic acid (RNA) >= lower limit of quantitation (LLOQ) (2 consecutive measurements >= LLOQ) at any point in the post-treatment period among participants with HCV RNA < LLOQ at the end of treatment. Participants with missing data were imputed as failures.
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
to 65 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
-
Participants who had a body mass index 18 to < 35 kg/m^2.
-
Females were either postmenopausal for at least 2 years, surgically sterile, or willing to use at least 2 effective forms of birth control.
-
Males must have been surgically sterile or agreed to use at least 2 effective forms of birth control throughout the course of the study.
-
Participants were in a condition of general good health, other than the HCV infection.
-
Participants had a chronic HCV genotype 1, 2, or 3 infection for at least 6 months, a plasma HCV RNA > 50,000 IU/mL, and FibroTest score <= 0.72 and aspartate aminotransferase (AST) to platelet ratio index <= 2, Fibroscan® result of < 9.6 kilopascal (kPa), or absence of cirrhosis based on a liver biopsy.
Exclusion Criteria:
-
Positive drug screen
-
Previous use of anti-HCV agents
-
History of cardiac disease
-
History of uncontrolled diabetes or diabetes requiring insulin
-
Abnormal laboratory results
-
Females who were pregnant or planned to become pregnant within 6 months after their last dose of study drug/RBV or were breastfeeding; males whose partners were pregnant or would become pregnant within 6 months after their last dose of study drug/RBV
-
Positive test result for hepatitis B surface antigen (HBsAg) or anti-human immunodeficiency virus (HIV) antibody (Ab). Negative HIV status was to be confirmed at screening.
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- AbbVie (prior sponsor, Abbott)
Investigators
- Study Director: Andrew Campbell, MD, AbbVie
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
None provided.Responsible Party:
AbbVie (prior sponsor, Abbott)
ClinicalTrials.gov Identifier:
NCT01458535
Other Study ID Numbers:
- M12-998
First Posted:
Oct 25, 2011
Last Update Posted:
Jul 11, 2016
Last Verified:
May 1, 2016
Keywords provided by AbbVie (prior sponsor, Abbott)
Additional relevant MeSH terms:
Study Results
Participant Flow
| Recruitment Details | |
|---|---|
| Pre-assignment Detail |
| Arm/Group Title | ABT-450/r and ABT-267 Plus RBV in Genotype 1 Participants | ABT-450/r and ABT-267 Plus RBV in Genotype 2 Participants | ABT-450/r and ABT-267 Plus RBV in Genotype 3 Participants | ABT-450/r and ABT-267 in Genotype 1 Participants | ABT-450/r and ABT-267 in Genotype 2 Participants | ABT-450/r and ABT-267 in Genotype 3 Participants |
|---|---|---|---|---|---|---|
| Arm/Group Description | ABT-450/r (200/100 mg) once daily (QD) and ABT-267 (25 mg) QD plus weight-based ribavirin (RBV) divided twice daily (BID) in treatment-naïve genotype 1 participants. | ABT-450/r (200/100 mg) once daily (QD) and ABT-267 (25 mg) QD plus weight-based ribavirin (RBV) divided BID in treatment-naïve genotype 2 participants. | ABT-450/r (200/100 mg) once daily (QD) and ABT-267 (25 mg) QD plus weight-based ribavirin (RBV) divided BID in treatment-naïve genotype 3 participants. | ABT-450/r (200/100 mg) once daily (QD) and ABT-267 (25 mg) QD in treatment-naïve genotype 1 participants. | ABT-450/r (200/100 mg) once daily (QD) and ABT-267 (25 mg) QD in treatment-naïve genotype 2 participants. | ABT-450/r (200/100 mg) once daily (QD) and ABT-267 (25 mg) QD in treatment-naïve genotype 3 participants. |
| Period Title: Overall Study | ||||||
| STARTED | 10 | 10 | 10 | 10 | 10 | 11 |
| COMPLETED | 10 | 8 | 8 | 6 | 6 | 7 |
| NOT COMPLETED | 0 | 2 | 2 | 4 | 4 | 4 |
Baseline Characteristics
| Arm/Group Title | ABT-450/r and ABT-267 Plus RBV in Genotype 1 Participants | ABT-450/r and ABT-267 Plus RBV in Genotype 2 Participants | ABT-450/r and ABT-267 Plus RBV in Genotype 3 Participants | ABT-450/r and ABT-267 in Genotype 1 Participants | ABT-450/r and ABT-267 in Genotype 2 Participants | ABT-450/r and ABT-267 in Genotype 3 Participants | Total |
|---|---|---|---|---|---|---|---|
| Arm/Group Description | ABT-450/r (200/100 mg) once daily (QD) and ABT-267 (25 mg) QD plus weight-based ribavirin (RBV) divided BID in treatment-naïve genotype 1 participants. | ABT-450/r (200/100 mg) once daily (QD) and ABT-267 (25 mg) QD plus weight-based ribavirin (RBV) divided BID in treatment-naïve genotype 2 participants. | ABT-450/r (200/100 mg) once daily (QD) and ABT-267 (25 mg) QD plus weight-based ribavirin (RBV) divided BID in treatment-naïve genotype 3 participants. | ABT-450/r (200/100 mg) once daily (QD) and ABT-267 (25 mg) QD in treatment-naïve genotype 1 participants. | ABT-450/r (200/100 mg) once daily (QD) and ABT-267 (25 mg) QD in treatment-naïve genotype 2 participants. | ABT-450/r (200/100 mg) once daily (QD) and ABT-267 (25 mg) QD in treatment-naïve genotype 3 participants. | Total of all reporting groups |
| Overall Participants | 10 | 10 | 10 | 10 | 10 | 11 | 61 |
| Age (years) [Mean (Standard Deviation) ] | |||||||
| Mean (Standard Deviation) [years] |
44.3
(12.19)
|
51.1
(8.25)
|
40.3
(13.10)
|
45.9
(7.03)
|
54.9
(10.85)
|
48.7
(8.91)
|
47.6
(10.90)
|
| Sex: Female, Male (Count of Participants) | |||||||
| Female |
8
80%
|
2
20%
|
3
30%
|
7
70%
|
3
30%
|
4
36.4%
|
27
44.3%
|
| Male |
2
20%
|
8
80%
|
7
70%
|
3
30%
|
7
70%
|
7
63.6%
|
34
55.7%
|
| HCV Genotype/ Subtype (participants) [Number] | |||||||
| 1A |
8
80%
|
0
0%
|
0
0%
|
8
80%
|
0
0%
|
0
0%
|
16
26.2%
|
| 1B |
2
20%
|
0
0%
|
0
0%
|
2
20%
|
0
0%
|
0
0%
|
4
6.6%
|
| 2A |
0
0%
|
2
20%
|
0
0%
|
0
0%
|
2
20%
|
0
0%
|
4
6.6%
|
| 2B |
0
0%
|
8
80%
|
0
0%
|
0
0%
|
8
80%
|
0
0%
|
16
26.2%
|
| 3A |
0
0%
|
0
0%
|
10
100%
|
0
0%
|
0
0%
|
11
100%
|
21
34.4%
|
| 3B |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Interleukin 28B (IL28B) (participants) [Number] | |||||||
| CC |
1
10%
|
2
20%
|
2
20%
|
4
40%
|
4
40%
|
3
27.3%
|
16
26.2%
|
| CT |
7
70%
|
4
40%
|
7
70%
|
4
40%
|
5
50%
|
7
63.6%
|
34
55.7%
|
| TT |
2
20%
|
4
40%
|
1
10%
|
2
20%
|
1
10%
|
1
9.1%
|
11
18%
|
| Missing |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
Outcome Measures
| Title | Percentage of Participants With Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Suppressed Below the Lower Limit of Quantitation (LLOQ) From Week 4 Through Week 12 [(Extended Rapid Virologic Response (eRVR)] |
|---|---|
| Description | Analysis of the percentage of participants with hepatitis C virus ribonucleic acid less than the lower limit of quantitation (< 25 IU/mL). Participants with missing data were imputed as failures. |
| Time Frame | Week 4 through Week 12 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Efficacy analyses included all participants who received at least 1 dose of study drug (ITT). |
| Arm/Group Title | ABT-450/r and ABT-267 Plus RBV in Genotype 1 Participants | ABT-450/r and ABT-267 Plus RBV in Genotype 2 Participants | ABT-450/r and ABT-267 Plus RBV in Genotype 3 Participants | ABT-450/r and ABT-267 in Genotype 1 Participants | ABT-450/r and ABT-267 in Genotype 2 Participants | ABT-450/r and ABT-267 in Genotype 3 Participants |
|---|---|---|---|---|---|---|
| Arm/Group Description | ABT-450/r (200/100 mg) once daily (QD) and ABT-267 (25 mg) QD plus weight-based ribavirin (RBV) divided BID in treatment-naïve genotype 1 participants. | ABT-450/r (200/100 mg) once daily (QD) and ABT-267 (25 mg) QD plus weight-based ribavirin (RBV) divided BID in treatment-naïve genotype 2 participants. | ABT-450/r (200/100 mg) once daily (QD) and ABT-267 (25 mg) QD plus weight-based ribavirin (RBV) divided BID in treatment-naïve genotype 3 participants. | ABT-450/r (200/100 mg) once daily (QD) and ABT-267 (25 mg) QD in treatment-naïve genotype 1 participants. | ABT-450/r (200/100 mg) once daily (QD) and ABT-267 (25 mg) QD in treatment-naïve genotype 2 participants. | ABT-450/r (200/100 mg) once daily (QD) and ABT-267 (25 mg) QD in treatment-naïve genotype 3 participants. |
| Measure Participants | 10 | 10 | 10 | 10 | 10 | 11 |
| Number [percentage of participants] |
100
1000%
|
90.0
900%
|
70.0
700%
|
90.0
900%
|
80.0
800%
|
18.2
165.5%
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | ABT-450/r and ABT-267 Plus RBV in Genotype 1 Participants, ABT-450/r and ABT-267 in Genotype 1 Participants |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.157 |
| Comments | ||
| Method | Cochran-Mantel-Haenszel | |
| Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | ABT-450/r and ABT-267 Plus RBV in Genotype 2 Participants, ABT-450/r and ABT-267 in Genotype 2 Participants |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.999 |
| Comments | ||
| Method | Cochran-Mantel-Haenszel | |
| Comments | ||
Statistical Analysis 3
| Statistical Analysis Overview | Comparison Group Selection | ABT-450/r and ABT-267 Plus RBV in Genotype 3 Participants, ABT-450/r and ABT-267 in Genotype 3 Participants |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.045 |
| Comments | ||
| Method | Cochran-Mantel-Haenszel | |
| Comments | ||
| Title | Percentage of Participants With Sustained Virologic Response 12 Weeks (SVR12) Post-treatment |
|---|---|
| Description | Sustained Virologic Response 12 (SVR12) is defined as plasma hepatitis C virus ribonucleic acid (HCV RNA) less than the lower limit of quantification (< LLOQ; < 25 IU/mL) 12 weeks after the last dose of study drug. Participants with missing data were imputed as failures. |
| Time Frame | Post-treatment Day 1 to Post-treatment Week 12 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Efficacy analyses included all participants who received at least 1 dose of study drug (ITT). |
| Arm/Group Title | ABT-450/r and ABT-267 Plus RBV in Genotype 1 Participants | ABT-450/r and ABT-267 Plus RBV in Genotype 2 Participants | ABT-450/r and ABT-267 Plus RBV in Genotype 3 Participants | ABT-450/r and ABT-267 in Genotype 1 Participants | ABT-450/r and ABT-267 in Genotype 2 Participants | ABT-450/r and ABT-267 in Genotype 3 Participants |
|---|---|---|---|---|---|---|
| Arm/Group Description | ABT-450/r (200/100 mg) once daily (QD) and ABT-267 (25 mg) QD plus weight-based ribavirin (RBV) divided BID in treatment-naïve genotype 1 participants. | ABT-450/r (200/100 mg) once daily (QD) and ABT-267 (25 mg) QD plus weight-based ribavirin (RBV) divided BID in treatment-naïve genotype 2 participants. | ABT-450/r (200/100 mg) once daily (QD) and ABT-267 (25 mg) QD plus weight-based ribavirin (RBV) divided BID in treatment-naïve genotype 3 participants. | ABT-450/r (200/100 mg) once daily (QD) and ABT-267 (25 mg) QD in treatment-naïve genotype 1 participants. | ABT-450/r (200/100 mg) once daily (QD) and ABT-267 (25 mg) QD in treatment-naïve genotype 2 participants. | ABT-450/r (200/100 mg) once daily (QD) and ABT-267 (25 mg) QD in treatment-naïve genotype 3 participants. |
| Measure Participants | 10 | 10 | 10 | 10 | 10 | 11 |
| Number [percentage of participants] |
100
1000%
|
80.0
800%
|
50.0
500%
|
60.0
600%
|
60.0
600%
|
9.1
82.7%
|
| Title | Percentage of Participants With Sustained Virologic Response 24 Weeks (SVR24) Post-Treatment |
|---|---|
| Description | Sustained Virologic Response 24 (SVR24) is defined as plasma hepatitis C virus ribonucleic acid (HCV RNA) less than the lower limit of quantification (LLOQ; < 25 IU/mL) 24 weeks after the last dose of study drug. Participants with missing data were imputed as failures. |
| Time Frame | Post-treatment Day 1 to Post-treatment Week 24 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Efficacy analyses included all participants who received at least 1 dose of study drug (ITT). |
| Arm/Group Title | ABT-450/r and ABT-267 Plus RBV in Genotype 1 Participants | ABT-450/r and ABT-267 Plus RBV in Genotype 2 Participants | ABT-450/r and ABT-267 Plus RBV in Genotype 3 Participants | ABT-450/r and ABT-267 in Genotype 1 Participants | ABT-450/r and ABT-267 in Genotype 2 Participants | ABT-450/r and ABT-267 in Genotype 3 Participants |
|---|---|---|---|---|---|---|
| Arm/Group Description | ABT-450/r (200/100 mg) once daily (QD) and ABT-267 (25 mg) QD plus weight-based ribavirin (RBV) divided BID in treatment-naïve genotype 1 participants. | ABT-450/r (200/100 mg) once daily (QD) and ABT-267 (25 mg) QD plus weight-based ribavirin (RBV) divided BID in treatment-naïve genotype 2 participants. | ABT-450/r (200/100 mg) once daily (QD) and ABT-267 (25 mg) QD plus weight-based ribavirin (RBV) divided BID in treatment-naïve genotype 3 participants. | ABT-450/r (200/100 mg) once daily (QD) and ABT-267 (25 mg) QD in treatment-naïve genotype 1 participants. | ABT-450/r (200/100 mg) once daily (QD) and ABT-267 (25 mg) QD in treatment-naïve genotype 2 participants. | ABT-450/r (200/100 mg) once daily (QD) and ABT-267 (25 mg) QD in treatment-naïve genotype 3 participants. |
| Measure Participants | 10 | 10 | 10 | 10 | 10 | 11 |
| Number [percentage of participants] |
100
1000%
|
80.0
800%
|
40.0
400%
|
60.0
600%
|
60.0
600%
|
9.1
82.7%
|
| Title | Percentage of Participants With Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) < 1000 International Units Per Milliliter (IU/mL) |
|---|---|
| Description | Analysis of participants with HCV RNA levels below 1000 IU/mL at Week 2. Participants with missing data were imputed as failures. |
| Time Frame | Week 2 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Efficacy analyses included all participants who received at least 1 dose of study drug (ITT). |
| Arm/Group Title | ABT-450/r and ABT-267 Plus RBV in Genotype 1 Participants | ABT-450/r and ABT-267 Plus RBV in Genotype 2 Participants | ABT-450/r and ABT-267 Plus RBV in Genotype 3 Participants | ABT-450/r and ABT-267 in Genotype 1 Participants | ABT-450/r and ABT-267 in Genotype 2 Participants | ABT-450/r and ABT-267 in Genotype 3 Participants |
|---|---|---|---|---|---|---|
| Arm/Group Description | ABT-450/r (200/100 mg) once daily (QD) and ABT-267 (25 mg) QD plus weight-based ribavirin (RBV) divided BID in treatment-naïve genotype 1 participants. | ABT-450/r (200/100 mg) once daily (QD) and ABT-267 (25 mg) QD plus weight-based ribavirin (RBV) divided BID in treatment-naïve genotype 2 participants. | ABT-450/r (200/100 mg) once daily (QD) and ABT-267 (25 mg) QD plus weight-based ribavirin (RBV) divided BID in treatment-naïve genotype 3 participants. | ABT-450/r (200/100 mg) once daily (QD) and ABT-267 (25 mg) QD in treatment-naïve genotype 1 participants. | ABT-450/r (200/100 mg) once daily (QD) and ABT-267 (25 mg) QD in treatment-naïve genotype 2 participants. | ABT-450/r (200/100 mg) once daily (QD) and ABT-267 (25 mg) QD in treatment-naïve genotype 3 participants. |
| Measure Participants | 10 | 10 | 10 | 10 | 10 | 11 |
| Number [percentage of participants] |
100
1000%
|
100
1000%
|
100
1000%
|
100
1000%
|
100
1000%
|
100
909.1%
|
| Title | Percentage of Participants With Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Below the Lower Limit of Quantitation (LLOQ) at Week 4 Rapid Virologic Response (RVR) |
|---|---|
| Description | Analysis of percentage of participants with hepatitis C virus ribonucleic acid less than the lower limit of quantitation (< 25 IU/mL). Participants with missing data were imputed as failures. |
| Time Frame | Week 4 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Efficacy analyses included all participants who received at least 1 dose of study drug (ITT). |
| Arm/Group Title | ABT-450/r and ABT-267 Plus RBV in Genotype 1 Participants | ABT-450/r and ABT-267 Plus RBV in Genotype 2 Participants | ABT-450/r and ABT-267 Plus RBV in Genotype 3 Participants | ABT-450/r and ABT-267 in Genotype 1 Participants | ABT-450/r and ABT-267 in Genotype 2 Participants | ABT-450/r and ABT-267 in Genotype 3 Participants |
|---|---|---|---|---|---|---|
| Arm/Group Description | ABT-450/r (200/100 mg) once daily (QD) and ABT-267 (25 mg) QD plus weight-based ribavirin (RBV) divided BID in treatment-naïve genotype 1 participants. | ABT-450/r (200/100 mg) once daily (QD) and ABT-267 (25 mg) QD plus weight-based ribavirin (RBV) divided BID in treatment-naïve genotype 2 participants. | ABT-450/r (200/100 mg) once daily (QD) and ABT-267 (25 mg) QD plus weight-based ribavirin (RBV) divided BID in treatment-naïve genotype 3 participants. | ABT-450/r (200/100 mg) once daily (QD) and ABT-267 (25 mg) QD in treatment-naïve genotype 1 participants. | ABT-450/r (200/100 mg) once daily (QD) and ABT-267 (25 mg) QD in treatment-naïve genotype 2 participants. | ABT-450/r (200/100 mg) once daily (QD) and ABT-267 (25 mg) QD in treatment-naïve genotype 3 participants. |
| Measure Participants | 10 | 10 | 10 | 10 | 10 | 11 |
| Number [percentage of participants] |
100
1000%
|
100
1000%
|
90.0
900%
|
100
1000%
|
90.0
900%
|
27.3
248.2%
|
| Title | Percentage of Participants With Virologic Failure During Treatment |
|---|---|
| Description | Virologic failure during treatment is defined as a participant meeting any virologic stopping criteria, including 1) rebound (defined as the first day of 2 consecutive increases of at least 0.5 log10 IU/mL above nadir (local minimum value), or first day of 2 consecutive HCV RNA >= LLOQ for participants who previously achieved HCV RNA < LLOQ) during treatment, 2) participant who fails to suppress (defined as never achieving HCV RNA < LLOQ during treatment). |
| Time Frame | Day 1 through Week 12 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Efficacy analyses included all participants who received at least 1 dose of study drug (ITT). |
| Arm/Group Title | ABT-450/r and ABT-267 Plus RBV in Genotype 1 Participants | ABT-450/r and ABT-267 Plus RBV in Genotype 2 Participants | ABT-450/r and ABT-267 Plus RBV in Genotype 3 Participants | ABT-450/r and ABT-267 in Genotype 1 Participants | ABT-450/r and ABT-267 in Genotype 2 Participants | ABT-450/r and ABT-267 in Genotype 3 Participants |
|---|---|---|---|---|---|---|
| Arm/Group Description | ABT-450/r (200/100 mg) once daily (QD) and ABT-267 (25 mg) QD plus weight-based ribavirin (RBV) divided BID in treatment-naïve genotype 1 participants. | ABT-450/r (200/100 mg) once daily (QD) and ABT-267 (25 mg) QD plus weight-based ribavirin (RBV) divided BID in treatment-naïve genotype 2 participants. | ABT-450/r (200/100 mg) once daily (QD) and ABT-267 (25 mg) QD plus weight-based ribavirin (RBV) divided BID in treatment-naïve genotype 3 participants. | ABT-450/r (200/100 mg) once daily (QD) and ABT-267 (25 mg) QD in treatment-naïve genotype 1 participants. | ABT-450/r (200/100 mg) once daily (QD) and ABT-267 (25 mg) QD in treatment-naïve genotype 2 participants. | ABT-450/r (200/100 mg) once daily (QD) and ABT-267 (25 mg) QD in treatment-naïve genotype 3 participants. |
| Measure Participants | 10 | 10 | 10 | 10 | 10 | 11 |
| Participant Rebounds |
0
0%
|
10.0
100%
|
30.0
300%
|
10.0
100%
|
10.0
100%
|
72.7
660.9%
|
| Participants who fail to Suppress |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Title | Percentage of Participants Who Experienced Virologic Relapse Through End of Post Treatment Period (up to 48 Weeks) |
|---|---|
| Description | Virologic relapse is defined as confirmed hepatitis C virus (HCV) ribonucleic acid (RNA) >= lower limit of quantitation (LLOQ) (2 consecutive measurements >= LLOQ) at any point in the post-treatment period among participants with HCV RNA < LLOQ at the end of treatment. Participants with missing data were imputed as failures. |
| Time Frame | Post-treatment Day 1 to Post-treatment Week 48 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Efficacy analyses included all participants who received at least 1 dose of study drug (ITT) with hepatitis C virus (HCV) ribonucleic acid (RNA) < lower limit of quantitation (LLOQ) at the final treatment visit who completed treatment. |
| Arm/Group Title | ABT-450/r and ABT-267 Plus RBV in Genotype 1 Participants | ABT-450/r and ABT-267 Plus RBV in Genotype 2 Participants | ABT-450/r and ABT-267 Plus RBV in Genotype 3 Participants | ABT-450/r and ABT-267 in Genotype 1 Participants | ABT-450/r and ABT-267 in Genotype 2 Participants | ABT-450/r and ABT-267 in Genotype 3 Participants |
|---|---|---|---|---|---|---|
| Arm/Group Description | ABT-450/r (200/100 mg) once daily (QD) and ABT-267 (25 mg) QD plus weight-based ribavirin (RBV) divided BID in treatment-naïve genotype 1 participants. | ABT-450/r (200/100 mg) once daily (QD) and ABT-267 (25 mg) QD plus weight-based ribavirin (RBV) divided BID in treatment-naïve genotype 2 participants. | ABT-450/r (200/100 mg) once daily (QD) and ABT-267 (25 mg) QD plus weight-based ribavirin (RBV) divided BID in treatment-naïve genotype 3 participants. | ABT-450/r (200/100 mg) once daily (QD) and ABT-267 (25 mg) QD in treatment-naïve genotype 1 participants. | ABT-450/r (200/100 mg) once daily (QD) and ABT-267 (25 mg) QD in treatment-naïve genotype 2 participants. | ABT-450/r (200/100 mg) once daily (QD) and ABT-267 (25 mg) QD in treatment-naïve genotype 3 participants. |
| Measure Participants | 10 | 9 | 7 | 9 | 9 | 2 |
| Number [percentage of participants] |
0
0%
|
0
0%
|
28.6
286%
|
22.2
222%
|
22.2
222%
|
50.0
454.5%
|
Adverse Events
| Time Frame | AEs and SAEs were collected from the time of study drug administration to 30 days after last dose of study drug (12 weeks); SAEs were also collected from the time that informed consent was obtained until the end of the study (up to 60 weeks). | |||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Adverse Event Reporting Description | ||||||||||||
| Arm/Group Title | ABT-450/r and ABT-267 Plus RBV in Genotype 1 Participants | ABT-450/r and ABT-267 Plus RBV in Genotype 2 Participants | ABT-450/r and ABT-267 Plus RBV in Genotype 3 Participants | ABT-450/r and ABT-267 in Genotype 1 Participants | ABT-450/r and ABT-267 in Genotype 2 Participants | ABT-450/r and ABT-267 in Genotype 3 Participants | ||||||
| Arm/Group Description | ABT-450/r (200/100 mg) once daily (QD) and ABT-267 (25 mg) QD plus weight-based ribavirin (RBV) divided twice daily (BID) in treatment-naïve participants with HCV genotype 1 infection. | ABT-450/r (200/100 mg) once daily (QD) and ABT-267 (25 mg) QD plus weight-based ribavirin (RBV) divided BID in treatment-naïve participants with HCV genotype 2 infection. | ABT-450/r (200/100 mg) once daily (QD) and ABT-267 (25 mg) QD plus weight-based ribavirin (RBV) divided BID in treatment-naïve participants with HCV genotype 3 infection. | ABT-450/r (200/100 mg) once daily (QD) and ABT-267 (25 mg) QD in treatment-naïve participants with HCV genotype 1 infection. | ABT-450/r (200/100 mg) once daily (QD) and ABT-267 (25 mg) QD in treatment-naïve participants with HCV genotype 2 infection. | ABT-450/r (200/100 mg) once daily (QD) and ABT-267 (25 mg) QD in treatment-naïve participants with HCV genotype 3 infection. | ||||||
All Cause Mortality |
||||||||||||
| ABT-450/r and ABT-267 Plus RBV in Genotype 1 Participants | ABT-450/r and ABT-267 Plus RBV in Genotype 2 Participants | ABT-450/r and ABT-267 Plus RBV in Genotype 3 Participants | ABT-450/r and ABT-267 in Genotype 1 Participants | ABT-450/r and ABT-267 in Genotype 2 Participants | ABT-450/r and ABT-267 in Genotype 3 Participants | |||||||
| 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 | / (NaN) | / (NaN) | / (NaN) | / (NaN) | / (NaN) | / (NaN) | ||||||
Serious Adverse Events |
||||||||||||
| ABT-450/r and ABT-267 Plus RBV in Genotype 1 Participants | ABT-450/r and ABT-267 Plus RBV in Genotype 2 Participants | ABT-450/r and ABT-267 Plus RBV in Genotype 3 Participants | ABT-450/r and ABT-267 in Genotype 1 Participants | ABT-450/r and ABT-267 in Genotype 2 Participants | ABT-450/r and ABT-267 in Genotype 3 Participants | |||||||
| 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 | 1/10 (10%) | 0/10 (0%) | 0/10 (0%) | 1/10 (10%) | 1/10 (10%) | 1/11 (9.1%) | ||||||
| Gastrointestinal disorders | ||||||||||||
| HAEMATEMESIS | 0/10 (0%) | 0/10 (0%) | 0/10 (0%) | 0/10 (0%) | 1/10 (10%) | 0/11 (0%) | ||||||
| Infections and infestations | ||||||||||||
| CLOSTRIDIAL INFECTION | 0/10 (0%) | 0/10 (0%) | 0/10 (0%) | 0/10 (0%) | 1/10 (10%) | 0/11 (0%) | ||||||
| MENINGITIS HERPES | 0/10 (0%) | 0/10 (0%) | 0/10 (0%) | 0/10 (0%) | 0/10 (0%) | 1/11 (9.1%) | ||||||
| Injury, poisoning and procedural complications | ||||||||||||
| FACIAL BONES FRACTURE | 1/10 (10%) | 0/10 (0%) | 0/10 (0%) | 0/10 (0%) | 0/10 (0%) | 0/11 (0%) | ||||||
| LUMBAR VERTEBRAL FRACTURE | 1/10 (10%) | 0/10 (0%) | 0/10 (0%) | 0/10 (0%) | 0/10 (0%) | 0/11 (0%) | ||||||
| RIB FRACTURE | 1/10 (10%) | 0/10 (0%) | 0/10 (0%) | 0/10 (0%) | 0/10 (0%) | 0/11 (0%) | ||||||
| ROAD TRAFFIC ACCIDENT | 1/10 (10%) | 0/10 (0%) | 0/10 (0%) | 0/10 (0%) | 0/10 (0%) | 0/11 (0%) | ||||||
| TRAUMATIC LIVER INJURY | 1/10 (10%) | 0/10 (0%) | 0/10 (0%) | 0/10 (0%) | 0/10 (0%) | 0/11 (0%) | ||||||
| Neoplasms benign, malignant and unspecified (incl cysts and polyps) | ||||||||||||
| HEPATIC NEOPLASM MALIGNANT | 0/10 (0%) | 0/10 (0%) | 0/10 (0%) | 0/10 (0%) | 1/10 (10%) | 0/11 (0%) | ||||||
| Respiratory, thoracic and mediastinal disorders | ||||||||||||
| PLEURAL EFFUSION | 0/10 (0%) | 0/10 (0%) | 0/10 (0%) | 0/10 (0%) | 1/10 (10%) | 0/11 (0%) | ||||||
| PNEUMOTHORAX | 0/10 (0%) | 0/10 (0%) | 0/10 (0%) | 0/10 (0%) | 1/10 (10%) | 0/11 (0%) | ||||||
| Vascular disorders | ||||||||||||
| ARTERIOSCLEROSIS | 0/10 (0%) | 0/10 (0%) | 0/10 (0%) | 1/10 (10%) | 0/10 (0%) | 0/11 (0%) | ||||||
Other (Not Including Serious) Adverse Events |
||||||||||||
| ABT-450/r and ABT-267 Plus RBV in Genotype 1 Participants | ABT-450/r and ABT-267 Plus RBV in Genotype 2 Participants | ABT-450/r and ABT-267 Plus RBV in Genotype 3 Participants | ABT-450/r and ABT-267 in Genotype 1 Participants | ABT-450/r and ABT-267 in Genotype 2 Participants | ABT-450/r and ABT-267 in Genotype 3 Participants | |||||||
| 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 | 9/10 (90%) | 9/10 (90%) | 8/10 (80%) | 9/10 (90%) | 9/10 (90%) | 10/11 (90.9%) | ||||||
| Blood and lymphatic system disorders | ||||||||||||
| ANAEMIA | 0/10 (0%) | 2/10 (20%) | 1/10 (10%) | 0/10 (0%) | 0/10 (0%) | 0/11 (0%) | ||||||
| LYMPHADENOPATHY | 0/10 (0%) | 0/10 (0%) | 0/10 (0%) | 1/10 (10%) | 0/10 (0%) | 0/11 (0%) | ||||||
| Ear and labyrinth disorders | ||||||||||||
| EAR PAIN | 0/10 (0%) | 0/10 (0%) | 0/10 (0%) | 1/10 (10%) | 0/10 (0%) | 0/11 (0%) | ||||||
| HYPERACUSIS | 0/10 (0%) | 0/10 (0%) | 0/10 (0%) | 0/10 (0%) | 1/10 (10%) | 0/11 (0%) | ||||||
| Eye disorders | ||||||||||||
| GROWTH OF EYELASHES | 0/10 (0%) | 0/10 (0%) | 0/10 (0%) | 0/10 (0%) | 1/10 (10%) | 0/11 (0%) | ||||||
| VISION BLURRED | 1/10 (10%) | 0/10 (0%) | 0/10 (0%) | 0/10 (0%) | 1/10 (10%) | 0/11 (0%) | ||||||
| Gastrointestinal disorders | ||||||||||||
| ABDOMINAL DISTENSION | 0/10 (0%) | 0/10 (0%) | 0/10 (0%) | 1/10 (10%) | 0/10 (0%) | 0/11 (0%) | ||||||
| ABDOMINAL PAIN | 0/10 (0%) | 1/10 (10%) | 0/10 (0%) | 0/10 (0%) | 1/10 (10%) | 0/11 (0%) | ||||||
| ABDOMINAL PAIN UPPER | 1/10 (10%) | 0/10 (0%) | 1/10 (10%) | 2/10 (20%) | 1/10 (10%) | 0/11 (0%) | ||||||
| APHTHOUS STOMATITIS | 0/10 (0%) | 0/10 (0%) | 0/10 (0%) | 1/10 (10%) | 0/10 (0%) | 0/11 (0%) | ||||||
| CONSTIPATION | 1/10 (10%) | 0/10 (0%) | 0/10 (0%) | 2/10 (20%) | 1/10 (10%) | 0/11 (0%) | ||||||
| DIARRHOEA | 2/10 (20%) | 1/10 (10%) | 1/10 (10%) | 2/10 (20%) | 2/10 (20%) | 1/11 (9.1%) | ||||||
| DRY MOUTH | 1/10 (10%) | 0/10 (0%) | 0/10 (0%) | 0/10 (0%) | 0/10 (0%) | 0/11 (0%) | ||||||
| DYSPEPSIA | 0/10 (0%) | 0/10 (0%) | 0/10 (0%) | 1/10 (10%) | 0/10 (0%) | 1/11 (9.1%) | ||||||
| ERUCTATION | 0/10 (0%) | 1/10 (10%) | 0/10 (0%) | 0/10 (0%) | 0/10 (0%) | 0/11 (0%) | ||||||
| FAECES PALE | 0/10 (0%) | 0/10 (0%) | 0/10 (0%) | 1/10 (10%) | 0/10 (0%) | 0/11 (0%) | ||||||
| FLATULENCE | 0/10 (0%) | 0/10 (0%) | 0/10 (0%) | 1/10 (10%) | 1/10 (10%) | 0/11 (0%) | ||||||
| GASTRITIS | 1/10 (10%) | 0/10 (0%) | 0/10 (0%) | 0/10 (0%) | 0/10 (0%) | 0/11 (0%) | ||||||
| GASTROOESOPHAGEAL REFLUX DISEASE | 2/10 (20%) | 0/10 (0%) | 1/10 (10%) | 0/10 (0%) | 0/10 (0%) | 0/11 (0%) | ||||||
| GINGIVAL BLEEDING | 1/10 (10%) | 0/10 (0%) | 0/10 (0%) | 0/10 (0%) | 0/10 (0%) | 0/11 (0%) | ||||||
| IMPAIRED GASTRIC EMPTYING | 1/10 (10%) | 0/10 (0%) | 0/10 (0%) | 0/10 (0%) | 0/10 (0%) | 0/11 (0%) | ||||||
| NAUSEA | 6/10 (60%) | 3/10 (30%) | 1/10 (10%) | 2/10 (20%) | 2/10 (20%) | 1/11 (9.1%) | ||||||
| SENSITIVITY OF TEETH | 1/10 (10%) | 1/10 (10%) | 0/10 (0%) | 0/10 (0%) | 0/10 (0%) | 0/11 (0%) | ||||||
| STOMATITIS | 0/10 (0%) | 1/10 (10%) | 0/10 (0%) | 0/10 (0%) | 0/10 (0%) | 0/11 (0%) | ||||||
| VOMITING | 1/10 (10%) | 1/10 (10%) | 0/10 (0%) | 0/10 (0%) | 1/10 (10%) | 0/11 (0%) | ||||||
| General disorders | ||||||||||||
| FATIGUE | 6/10 (60%) | 3/10 (30%) | 2/10 (20%) | 4/10 (40%) | 3/10 (30%) | 1/11 (9.1%) | ||||||
| INFLUENZA LIKE ILLNESS | 0/10 (0%) | 0/10 (0%) | 1/10 (10%) | 0/10 (0%) | 0/10 (0%) | 0/11 (0%) | ||||||
| IRRITABILITY | 0/10 (0%) | 1/10 (10%) | 0/10 (0%) | 1/10 (10%) | 2/10 (20%) | 0/11 (0%) | ||||||
| MALAISE | 0/10 (0%) | 0/10 (0%) | 1/10 (10%) | 0/10 (0%) | 0/10 (0%) | 0/11 (0%) | ||||||
| PAIN | 0/10 (0%) | 0/10 (0%) | 1/10 (10%) | 0/10 (0%) | 0/10 (0%) | 0/11 (0%) | ||||||
| PYREXIA | 0/10 (0%) | 0/10 (0%) | 1/10 (10%) | 0/10 (0%) | 0/10 (0%) | 0/11 (0%) | ||||||
| Hepatobiliary disorders | ||||||||||||
| JAUNDICE | 1/10 (10%) | 0/10 (0%) | 0/10 (0%) | 0/10 (0%) | 0/10 (0%) | 0/11 (0%) | ||||||
| Immune system disorders | ||||||||||||
| HYPERSENSITIVITY | 0/10 (0%) | 0/10 (0%) | 0/10 (0%) | 0/10 (0%) | 1/10 (10%) | 0/11 (0%) | ||||||
| Infections and infestations | ||||||||||||
| BRONCHITIS | 2/10 (20%) | 0/10 (0%) | 0/10 (0%) | 1/10 (10%) | 0/10 (0%) | 0/11 (0%) | ||||||
| CELLULITIS | 0/10 (0%) | 0/10 (0%) | 0/10 (0%) | 1/10 (10%) | 0/10 (0%) | 0/11 (0%) | ||||||
| GROIN INFECTION | 0/10 (0%) | 1/10 (10%) | 0/10 (0%) | 0/10 (0%) | 0/10 (0%) | 0/11 (0%) | ||||||
| INFLUENZA | 0/10 (0%) | 0/10 (0%) | 1/10 (10%) | 0/10 (0%) | 0/10 (0%) | 0/11 (0%) | ||||||
| KIDNEY INFECTION | 0/10 (0%) | 0/10 (0%) | 0/10 (0%) | 0/10 (0%) | 1/10 (10%) | 0/11 (0%) | ||||||
| NASOPHARYNGITIS | 3/10 (30%) | 0/10 (0%) | 0/10 (0%) | 0/10 (0%) | 1/10 (10%) | 1/11 (9.1%) | ||||||
| PHARYNGITIS STREPTOCOCCAL | 0/10 (0%) | 0/10 (0%) | 0/10 (0%) | 1/10 (10%) | 0/10 (0%) | 0/11 (0%) | ||||||
| SINUSITIS | 1/10 (10%) | 0/10 (0%) | 0/10 (0%) | 1/10 (10%) | 0/10 (0%) | 0/11 (0%) | ||||||
| TONGUE ABSCESS | 0/10 (0%) | 0/10 (0%) | 1/10 (10%) | 0/10 (0%) | 0/10 (0%) | 0/11 (0%) | ||||||
| TOOTH INFECTION | 0/10 (0%) | 0/10 (0%) | 0/10 (0%) | 0/10 (0%) | 0/10 (0%) | 1/11 (9.1%) | ||||||
| UPPER RESPIRATORY TRACT INFECTION | 0/10 (0%) | 0/10 (0%) | 2/10 (20%) | 1/10 (10%) | 0/10 (0%) | 1/11 (9.1%) | ||||||
| URINARY TRACT INFECTION | 0/10 (0%) | 0/10 (0%) | 0/10 (0%) | 0/10 (0%) | 1/10 (10%) | 0/11 (0%) | ||||||
| VIRAL INFECTION | 0/10 (0%) | 0/10 (0%) | 0/10 (0%) | 0/10 (0%) | 0/10 (0%) | 1/11 (9.1%) | ||||||
| Injury, poisoning and procedural complications | ||||||||||||
| CONTUSION | 0/10 (0%) | 0/10 (0%) | 0/10 (0%) | 0/10 (0%) | 1/10 (10%) | 0/11 (0%) | ||||||
| INJURY | 1/10 (10%) | 0/10 (0%) | 0/10 (0%) | 0/10 (0%) | 0/10 (0%) | 0/11 (0%) | ||||||
| LACERATION | 1/10 (10%) | 0/10 (0%) | 0/10 (0%) | 0/10 (0%) | 0/10 (0%) | 0/11 (0%) | ||||||
| LIGAMENT SPRAIN | 0/10 (0%) | 0/10 (0%) | 0/10 (0%) | 0/10 (0%) | 1/10 (10%) | 0/11 (0%) | ||||||
| MUSCLE STRAIN | 1/10 (10%) | 0/10 (0%) | 0/10 (0%) | 0/10 (0%) | 0/10 (0%) | 0/11 (0%) | ||||||
| POST-TRAUMATIC PAIN | 0/10 (0%) | 0/10 (0%) | 0/10 (0%) | 1/10 (10%) | 0/10 (0%) | 0/11 (0%) | ||||||
| Investigations | ||||||||||||
| ALANINE AMINOTRANSFERASE INCREASED | 1/10 (10%) | 0/10 (0%) | 0/10 (0%) | 0/10 (0%) | 0/10 (0%) | 1/11 (9.1%) | ||||||
| ASPARTATE AMINOTRANSFERASE INCREASED | 1/10 (10%) | 0/10 (0%) | 0/10 (0%) | 0/10 (0%) | 0/10 (0%) | 0/11 (0%) | ||||||
| BLOOD BILIRUBIN INCREASED | 1/10 (10%) | 0/10 (0%) | 0/10 (0%) | 0/10 (0%) | 0/10 (0%) | 0/11 (0%) | ||||||
| BLOOD CREATININE INCREASED | 0/10 (0%) | 1/10 (10%) | 0/10 (0%) | 0/10 (0%) | 0/10 (0%) | 0/11 (0%) | ||||||
| BLOOD TRIGLYCERIDES INCREASED | 0/10 (0%) | 0/10 (0%) | 0/10 (0%) | 1/10 (10%) | 0/10 (0%) | 0/11 (0%) | ||||||
| CREATININE RENAL CLEARANCE DECREASED | 0/10 (0%) | 0/10 (0%) | 0/10 (0%) | 1/10 (10%) | 0/10 (0%) | 0/11 (0%) | ||||||
| HAEMOGLOBIN DECREASED | 0/10 (0%) | 2/10 (20%) | 0/10 (0%) | 0/10 (0%) | 0/10 (0%) | 0/11 (0%) | ||||||
| INTRAOCULAR PRESSURE INCREASED | 1/10 (10%) | 0/10 (0%) | 0/10 (0%) | 0/10 (0%) | 0/10 (0%) | 0/11 (0%) | ||||||
| URINE OUTPUT INCREASED | 0/10 (0%) | 0/10 (0%) | 0/10 (0%) | 0/10 (0%) | 1/10 (10%) | 0/11 (0%) | ||||||
| Metabolism and nutrition disorders | ||||||||||||
| DECREASED APPETITE | 1/10 (10%) | 1/10 (10%) | 1/10 (10%) | 0/10 (0%) | 2/10 (20%) | 0/11 (0%) | ||||||
| DIABETES MELLITUS | 0/10 (0%) | 0/10 (0%) | 0/10 (0%) | 0/10 (0%) | 0/10 (0%) | 1/11 (9.1%) | ||||||
| HYPOKALAEMIA | 0/10 (0%) | 0/10 (0%) | 0/10 (0%) | 0/10 (0%) | 0/10 (0%) | 1/11 (9.1%) | ||||||
| HYPOPHOSPHATAEMIA | 1/10 (10%) | 0/10 (0%) | 0/10 (0%) | 0/10 (0%) | 0/10 (0%) | 0/11 (0%) | ||||||
| Musculoskeletal and connective tissue disorders | ||||||||||||
| ARTHRALGIA | 2/10 (20%) | 1/10 (10%) | 1/10 (10%) | 1/10 (10%) | 1/10 (10%) | 1/11 (9.1%) | ||||||
| ARTHRITIS | 0/10 (0%) | 1/10 (10%) | 0/10 (0%) | 0/10 (0%) | 0/10 (0%) | 0/11 (0%) | ||||||
| BACK PAIN | 1/10 (10%) | 0/10 (0%) | 0/10 (0%) | 2/10 (20%) | 0/10 (0%) | 0/11 (0%) | ||||||
| FLANK PAIN | 0/10 (0%) | 0/10 (0%) | 0/10 (0%) | 0/10 (0%) | 1/10 (10%) | 0/11 (0%) | ||||||
| MUSCULOSKELETAL PAIN | 1/10 (10%) | 0/10 (0%) | 0/10 (0%) | 1/10 (10%) | 0/10 (0%) | 0/11 (0%) | ||||||
| MYALGIA | 2/10 (20%) | 1/10 (10%) | 0/10 (0%) | 1/10 (10%) | 1/10 (10%) | 0/11 (0%) | ||||||
| OSTEOPENIA | 1/10 (10%) | 0/10 (0%) | 0/10 (0%) | 0/10 (0%) | 0/10 (0%) | 0/11 (0%) | ||||||
| PAIN IN EXTREMITY | 2/10 (20%) | 0/10 (0%) | 0/10 (0%) | 0/10 (0%) | 0/10 (0%) | 0/11 (0%) | ||||||
| Neoplasms benign, malignant and unspecified (incl cysts and polyps) | ||||||||||||
| LIPOMA | 0/10 (0%) | 0/10 (0%) | 1/10 (10%) | 0/10 (0%) | 0/10 (0%) | 0/11 (0%) | ||||||
| SKIN CANCER | 0/10 (0%) | 1/10 (10%) | 0/10 (0%) | 0/10 (0%) | 0/10 (0%) | 0/11 (0%) | ||||||
| TRANSITIONAL CELL CARCINOMA | 0/10 (0%) | 0/10 (0%) | 0/10 (0%) | 0/10 (0%) | 1/10 (10%) | 0/11 (0%) | ||||||
| Nervous system disorders | ||||||||||||
| DIZZINESS | 0/10 (0%) | 1/10 (10%) | 0/10 (0%) | 1/10 (10%) | 0/10 (0%) | 0/11 (0%) | ||||||
| DYSGEUSIA | 0/10 (0%) | 2/10 (20%) | 0/10 (0%) | 0/10 (0%) | 0/10 (0%) | 0/11 (0%) | ||||||
| HEADACHE | 4/10 (40%) | 2/10 (20%) | 1/10 (10%) | 1/10 (10%) | 1/10 (10%) | 2/11 (18.2%) | ||||||
| LETHARGY | 0/10 (0%) | 0/10 (0%) | 0/10 (0%) | 0/10 (0%) | 1/10 (10%) | 0/11 (0%) | ||||||
| MEMORY IMPAIRMENT | 1/10 (10%) | 0/10 (0%) | 0/10 (0%) | 1/10 (10%) | 0/10 (0%) | 0/11 (0%) | ||||||
| MIGRAINE | 0/10 (0%) | 1/10 (10%) | 0/10 (0%) | 0/10 (0%) | 0/10 (0%) | 0/11 (0%) | ||||||
| SINUS HEADACHE | 0/10 (0%) | 0/10 (0%) | 0/10 (0%) | 0/10 (0%) | 0/10 (0%) | 1/11 (9.1%) | ||||||
| Psychiatric disorders | ||||||||||||
| AGITATION | 1/10 (10%) | 0/10 (0%) | 0/10 (0%) | 0/10 (0%) | 0/10 (0%) | 0/11 (0%) | ||||||
| ANXIETY | 1/10 (10%) | 0/10 (0%) | 0/10 (0%) | 0/10 (0%) | 0/10 (0%) | 0/11 (0%) | ||||||
| DEPRESSION | 2/10 (20%) | 1/10 (10%) | 1/10 (10%) | 0/10 (0%) | 0/10 (0%) | 0/11 (0%) | ||||||
| INSOMNIA | 1/10 (10%) | 0/10 (0%) | 1/10 (10%) | 0/10 (0%) | 1/10 (10%) | 0/11 (0%) | ||||||
| PANIC ATTACK | 0/10 (0%) | 0/10 (0%) | 0/10 (0%) | 0/10 (0%) | 1/10 (10%) | 0/11 (0%) | ||||||
| Renal and urinary disorders | ||||||||||||
| DYSURIA | 1/10 (10%) | 0/10 (0%) | 0/10 (0%) | 0/10 (0%) | 0/10 (0%) | 0/11 (0%) | ||||||
| HAEMATURIA | 0/10 (0%) | 0/10 (0%) | 0/10 (0%) | 0/10 (0%) | 1/10 (10%) | 0/11 (0%) | ||||||
| NEPHROLITHIASIS | 0/10 (0%) | 0/10 (0%) | 0/10 (0%) | 0/10 (0%) | 1/10 (10%) | 0/11 (0%) | ||||||
| POLLAKIURIA | 0/10 (0%) | 0/10 (0%) | 0/10 (0%) | 0/10 (0%) | 1/10 (10%) | 0/11 (0%) | ||||||
| RENAL FAILURE | 0/10 (0%) | 0/10 (0%) | 1/10 (10%) | 0/10 (0%) | 0/10 (0%) | 0/11 (0%) | ||||||
| Reproductive system and breast disorders | ||||||||||||
| BREAST TENDERNESS | 0/10 (0%) | 0/10 (0%) | 0/10 (0%) | 0/10 (0%) | 1/10 (10%) | 0/11 (0%) | ||||||
| CYSTOCELE | 1/10 (10%) | 0/10 (0%) | 0/10 (0%) | 0/10 (0%) | 0/10 (0%) | 0/11 (0%) | ||||||
| PROSTATITIS | 0/10 (0%) | 0/10 (0%) | 0/10 (0%) | 0/10 (0%) | 1/10 (10%) | 0/11 (0%) | ||||||
| Respiratory, thoracic and mediastinal disorders | ||||||||||||
| ASTHMA | 0/10 (0%) | 0/10 (0%) | 0/10 (0%) | 0/10 (0%) | 0/10 (0%) | 1/11 (9.1%) | ||||||
| COUGH | 2/10 (20%) | 1/10 (10%) | 1/10 (10%) | 0/10 (0%) | 2/10 (20%) | 0/11 (0%) | ||||||
| NASAL CONGESTION | 1/10 (10%) | 0/10 (0%) | 0/10 (0%) | 0/10 (0%) | 1/10 (10%) | 0/11 (0%) | ||||||
| OROPHARYNGEAL PAIN | 0/10 (0%) | 0/10 (0%) | 0/10 (0%) | 0/10 (0%) | 0/10 (0%) | 1/11 (9.1%) | ||||||
| RESPIRATORY TRACT CONGESTION | 1/10 (10%) | 0/10 (0%) | 0/10 (0%) | 0/10 (0%) | 0/10 (0%) | 0/11 (0%) | ||||||
| Skin and subcutaneous tissue disorders | ||||||||||||
| ALOPECIA | 0/10 (0%) | 1/10 (10%) | 0/10 (0%) | 0/10 (0%) | 0/10 (0%) | 0/11 (0%) | ||||||
| COLD SWEAT | 0/10 (0%) | 0/10 (0%) | 0/10 (0%) | 0/10 (0%) | 1/10 (10%) | 0/11 (0%) | ||||||
| DERMATITIS CONTACT | 0/10 (0%) | 1/10 (10%) | 0/10 (0%) | 0/10 (0%) | 0/10 (0%) | 0/11 (0%) | ||||||
| INCREASED TENDENCY TO BRUISE | 1/10 (10%) | 0/10 (0%) | 0/10 (0%) | 0/10 (0%) | 0/10 (0%) | 0/11 (0%) | ||||||
| PRURITUS | 1/10 (10%) | 0/10 (0%) | 1/10 (10%) | 0/10 (0%) | 0/10 (0%) | 0/11 (0%) | ||||||
| RASH | 1/10 (10%) | 1/10 (10%) | 0/10 (0%) | 0/10 (0%) | 0/10 (0%) | 1/11 (9.1%) | ||||||
| URTICARIA | 0/10 (0%) | 1/10 (10%) | 0/10 (0%) | 0/10 (0%) | 0/10 (0%) | 0/11 (0%) | ||||||
| Vascular disorders | ||||||||||||
| HOT FLUSH | 0/10 (0%) | 0/10 (0%) | 0/10 (0%) | 0/10 (0%) | 2/10 (20%) | 0/11 (0%) | ||||||
| HYPOTENSION | 0/10 (0%) | 1/10 (10%) | 1/10 (10%) | 0/10 (0%) | 0/10 (0%) | 0/11 (0%) | ||||||
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 |
Responsible Party:
AbbVie (prior sponsor, Abbott)
ClinicalTrials.gov Identifier:
NCT01458535
Other Study ID Numbers:
- M12-998
First Posted:
Oct 25, 2011
Last Update Posted:
Jul 11, 2016
Last Verified:
May 1, 2016