A Study of the Safety, Effectiveness and Clinical Use of Maviret in Adolescent Patients With Chronic Hepatitis C Virus

Sponsor

AbbVie (Industry)

Overall Status

Recruiting

CT.gov ID

NCT04214028

Collaborator

(none)

Enrollment

Locations

Anticipated Duration (Months)

1.5

Patients Per Site

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This study will assess the safety and effectiveness of Maviret (Glecaprevir plus Pibrentasvir (GLE/PIB)) in adolescent participants diagnosed with chronic hepatitis C (CHC) in a real world setting across clinical practice in Japan.

Condition or Disease	Intervention/Treatment	Phase
Hepatitis C Virus (HCV)

Study Design

Study Type:

Observational

Anticipated Enrollment :

50 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

Real World Evidence of the Safety and Clinical Practice Use of Maviret in Adolescents Patients Infected With Chronic Hepatitis C Virus (All Case Survey)

Actual Study Start Date :

Dec 26, 2019

Anticipated Primary Completion Date :

Sep 26, 2024

Anticipated Study Completion Date :

Sep 26, 2024

Arms and Interventions

Arm	Intervention/Treatment
Maviret Participants Participants receiving glecaprevir plus pibrentasvir (GLE/PIB, other names: Maviret) as routine standard of care for HCV.

Outcome Measures

Primary Outcome Measures

Number of Participants with Adverse Drug Reactions (ADRs) [Up to approximately 36 weeks]
Adverse drug reactions are defined as adverse events of which a causal relationship with Maviret could not be ruled out.
Percentage of Participants with Adverse Drug Reactions (ADRs) [Up to approximately 36 weeks]
Adverse drug reactions are defined as adverse events of which a causal relationship with Maviret could not be ruled out.
Number of Participants with Serious Adverse Events (SAEs) [Up to approximately 36 weeks]
A serious adverse event (SAE) is an event that results in death, is life-threatening, requires or prolongs hospitalization, results in a congenital anomaly, persistent or significant disability/incapacity or is an important medical event that, based on medical judgement, may jeopardize the participant and may require medical or surgical intervention to prevent any of the outcomes listed above. Treatment-emergent serious adverse events (TESAEs) are defined as any event that began or worsened in severity after the first dose of study drug.
Percentage of Participants with Serious Adverse Events (SAEs) [Up to approximately 36 weeks]
A serious adverse event (SAE) is an event that results in death, is life-threatening, requires or prolongs hospitalization, results in a congenital anomaly, persistent or significant disability/incapacity or is an important medical event that, based on medical judgement, may jeopardize the participant and may require medical or surgical intervention to prevent any of the outcomes listed above. Treatment-emergent serious adverse events (TESAEs) are defined as any event that began or worsened in severity after the first dose of study drug.

Secondary Outcome Measures

Percentage of participants achieving Sustained Virologic Response 12 (SVR12) [At Week 12]
Defined as HCV Ribonucleic acid (RNA) not detected 12 weeks after the last dose of study drug.
Percentage of participants achieving Sustained Virologic Response (SVR) [At 4, 8, 12 and 24 weeks after last dose of Maviret (up to approximately 36 weeks)]
SVR defined as HCV Ribonucleic acid (RNA) < Lower limit of quantification (LLOQ).
Percentage of Participants with On-Treatment Virologic Failure (Breakthrough) [Up to approximately 36 weeks]
On-treatment virologic failure (breakthrough) defined as at least 1 documented HCV RNA < 50 IU/mL followed by HCV RNA ≥ 50 IU/mL during treatment or failure to suppress (each measured on-treatment HCV RNA value ≥ 50 IU/mL).
Percentage of Participants with After-Treatment Virologic Failure (Relapse) [Up to approximately 36 weeks]
After-treatment virologic failure (relapse) is defined as confirmed HCV RNA ≥ LLOQ between the end of treatment and 24 weeks after the last dose of study drug among participants who completed treatment with HCV RNA levels < LLOQ at the end of treatment.

Eligibility Criteria

Criteria

Ages Eligible for Study:

12 Years to 17 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Chronic Hepatitis C Virus (HCV) infection treated in daily practice with Maviret
Enrolled after Maviret treatment begins
Prior treatment with Maviret

Exclusion Criteria:

None

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Kariya Toyota General Hospital /ID# 239046	Kariya-shi	Aichi	Japan	448-8505
2	Nagoya City University Hospital /ID# 238745	Nagoya shi	Aichi	Japan	467-8602
3	Nagoya University Hospital /ID# 226746	Nagoya-shi	Aichi	Japan	4668560
4	Misawa Municipal Misawa Hospital /ID# 229544	Misawa-shi	Aomori	Japan	033-0123
5	Chiba University Hospital /ID# 225889	Chiba-shi	Chiba	Japan	260-8677
6	Matsuyama Red Cross Hospital /ID# 239387	Matsuyama-shi	Ehime	Japan	790-8524
7	Shikoku Central Hospital of the Mutual Aid /ID# 230273	Shikoku Chuo	Ehime	Japan	799-0101
8	Kurume University Hospital /ID# 224112	Kurume-shi	Fukuoka	Japan	830-0011
9	Shirakawa Kosei General Hosp. /ID# 240816	Shirakawa-shi	Fukushima	Japan	961-0005
10	Gifu Municipal Hospital /ID# 225890	Gifu-shi	Gifu	Japan	500-8513
11	Gunma University Hospital /ID# 231700	Maebashi-shi	Gunma	Japan	371-8511
12	Machida Clinic /ID# 238744	Maebashi	Gunma	Japan	371-0232
13	Heisei Hidaka Clinic /ID# 231758	Takasaki City	Gunma	Japan	370-0001
14	Hyogo Prefectural Amagasaki General Medical Center /ID# 239388	Amagasaki-shi	Hyogo	Japan	660-8550
15	Fujikawa Clinic /ID# 221135	Kanzaki-gun	Hyogo	Japan	679-2337
16	Yamada Clinic /ID# 225909	Fujisawa-shi	Kanagawa	Japan	251-0046
17	National Hospital Organization Sagamihara National Hospital /ID# 221136	Sagamihara-shi	Kanagawa	Japan	252-0392
18	Kawaguchi Clinic /ID# 226843	Yokohama-shi	Kanagawa	Japan	234-0054
19	Kumamoto Shinto General Hospital /ID# 223245	Kumamoto-shi	Kumamoto	Japan	862-8655
20	Kyoto Shimogamo Hospital /ID# 233903	Kyoto City	Kyoto	Japan	6060866
21	University Hospital Kyoto Prefectural University of Medicine /ID# 229599	Kyoto-shi	Kyoto	Japan	602-8566
22	Ise Red Cross Hospital /ID# 222018	Ise-shi	Mie	Japan	516-0008
23	Mie University Hospital /ID# 233864	Tsu-shi	Mie	Japan	514-8507
24	Aizawa Hospital /ID# 223247	Matsumoto-shi	Nagano	Japan	390-0814
25	Nara Hospital Kinki University Faculty of Medicine, /ID# 224609	Ikoma-shi	Nara	Japan	630-0227
26	Nakatsu Municipal Hospital /ID# 233390	Nakatsu-shi	Oita	Japan	871-0011
27	Saitama Children's Medical Center /ID# 227633	Saitama-shi	Saitama	Japan	330-8777
28	Tamakoshi Clinic /ID# 224113	Hamamatsu-shi	Shizuoka	Japan	335-0023
29	National Center for Child Health and Development /ID# 225293	Setagaya-ku	Tokyo	Japan	157-8535
30	Tottori University Hospital /ID# 227634	Yonago-shi	Tottori	Japan	683-8504
31	Heartlife Hospital /ID# 249394	Nakagami-gun		Japan	901-2417
32	Oita Cardiovascular Hospital /ID# 239725	Oita		Japan	861-1104
33	Shonai Hospital /ID# 232294	Yamagata		Japan	9978515