Use-Results Surveillance Study of Sovaldi® Plus Rebetol® in Japanese Patients With Chronic Genotype 2 Hepatitis C Virus Infection
A Prospective Observational Post-Marketing Study of Sovaldi® Plus Rebetol® in Japanese Patients With Chronic Genotype 2 Hepatitis C Virus Infection
1 other identifier
observational
554
1 country
45
Brief Summary
This use-results post-marketing surveillance (PMS) study for Sovaldi® tablets (sofosbuvir, SOF) administered in combination with Rebetol® capsules (ribavirin, REB) will evaluate the safety and efficacy of SOF administered in combination with ribavirin under real world use in Japan. Among adult patients with chronic genotype 2 hepatitis C virus (HCV) infection and treated with SOF+ribavirin in routine clinical use, the primary objective of this study is to evaluate the incidence of adverse drug reactions (ADRs) under real world settings.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Nov 2015
45 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 28, 2015
CompletedFirst Posted
Study publicly available on registry
September 29, 2015
CompletedStudy Start
First participant enrolled
November 12, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 12, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
June 12, 2017
CompletedAugust 1, 2017
July 1, 2017
1.6 years
September 28, 2015
July 28, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Incidence of adverse drug reaction (ADR) under real world settings
Up to 16 weeks
Secondary Outcomes (2)
Proportion of participants with sustained virologic response (SVR) 12 and 24 weeks after discontinuation of therapy (SVR12 and SVR24)
Posttreatment Weeks 12 and 24
Proportion of participants with HCV NS5B resistance associated variants among patients who do not achieve SVR at 12 weeks
Approximately 12 weeks after treatment completion or discontinuation
Study Arms (1)
SOF+REB
Adult patients with genotype 2 chronic HCV infection with or without compensated cirrhosis who take SOF+REB as part of routine clinical care at a participating clinical site.
Interventions
SOF 400 mg tablets administered orally once daily
REB capsules administered orally in a divided daily weight-based dose according to the package insert for the approved Rebetol® labeling in Japan (\< 60 kg = 600 mg , \> 60 kg to ≤ 80 kg = 800 mg, and \> 80 kg = 1000 mg)
Eligibility Criteria
Adult patients with serogroup 2 (genotype 2) chronic HCV infection with or without compensated cirrhosis who take SOF+REB as part of routine clinical care at a participating clinical site.
You may qualify if:
- Adult patients with serogroup 2 (genotype 2) chronic HCV infection with or without compensated cirrhosis
- Patients who are prescribed SOF+REB
You may not qualify if:
- None
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Gilead Scienceslead
- Merck Sharp & Dohme LLCcollaborator
Study Sites (45)
Unknown Facility
Ageo-shi, Japan
Unknown Facility
Bunkyō City, Japan
Unknown Facility
Chuo-shi, Japan
Unknown Facility
Fujioka-shi, Japan
Unknown Facility
Fukui-shi, Japan
Unknown Facility
Fukuoka, Japan
Unknown Facility
Hakodate-shi, Japan
Unknown Facility
Handa-shi, Japan
Unknown Facility
Ichihara-shi, Japan
Unknown Facility
Inashiki-gun, Japan
Unknown Facility
Iruma-gun, Japan
Unknown Facility
Kamogawa-shi, Japan
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Karatsu-shi, Japan
Unknown Facility
Kashiwa-shi, Japan
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Katsushika-ku, Japan
Unknown Facility
Kawagoe-shi, Japan
Unknown Facility
Kawasaki-shi, Japan
Unknown Facility
Kitamoto-shi, Japan
Unknown Facility
Kobe, Japan
Unknown Facility
Kodaira-shi, Japan
Unknown Facility
Kōtoku, Japan
Unknown Facility
Kurume-shi, Japan
Unknown Facility
Kyoto, Japan
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Matsue, Japan
Unknown Facility
Matsuyama, Japan
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Minatoku, Japan
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Miyazaki, Japan
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Morioka, Japan
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Nagoya, Japan
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Osaka, Japan
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Osakasayama-shi, Japan
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Saitama-shi, Japan
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Sakaishi, Japan
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Sapporo, Japan
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Shibuya-ku, Japan
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Shimotsuke-shi, Japan
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Shinjuku-ku, Japan
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Sumida-ku, Japan
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Tagawa-shi, Japan
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Tondabayashi-shi, Japan
Unknown Facility
Toyama, Japan
Unknown Facility
Toyoake-shi, Japan
Unknown Facility
Utsunomiya, Japan
Unknown Facility
Yanagawa-shi, Japan
Unknown Facility
Yokohama, Japan
Biospecimen
Whole blood
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Gilead Study Director
Gilead Sciences
Study Design
- Study Type
- observational
- Observational Model
- ECOLOGIC OR COMMUNITY
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 28, 2015
First Posted
September 29, 2015
Study Start
November 12, 2015
Primary Completion
June 12, 2017
Study Completion
June 12, 2017
Last Updated
August 1, 2017
Record last verified: 2017-07