Overview

This trial is active, not recruiting.

Condition hepatitis c virus infection
Treatments sof, cope
Sponsor Gilead Sciences
Collaborator Chugai Pharmaceutical
Start date September 2015
End date May 2017
Trial size 555 participants
Trial identifier NCT02537379, GS-US-334-1444 / COPE1501

Summary

This post-marketing surveillance (PMS) study for Sovaldi® tablets (sofosbuvir, SOF) administered in combination with Copegus® tablets (ribavirin, COPE) 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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model ecologic or community
Time perspective prospective
Arm
Adult patients with genotype 2 chronic HCV infection with or without compensated cirrhosis who take SOF+COPE as part of routine clinical care at a participating clinical site.
sof Sovaldi®
SOF 400 mg tablets administered orally once daily
cope Copegus®
COPE tablets administered orally in a divided daily weight-based dose according to the package insert for the approved Copegus® labeling in Japan (< 60 kg = 600 mg , > 60 kg to ≤ 80 kg = 800 mg, and > 80 kg = 1000 mg)

Primary Outcomes

Measure
Incidence of adverse drug reaction (ADR) under real world settings
time frame: Up to 16 weeks

Secondary Outcomes

Measure
Proportion of participants with sustained virologic response (SVR) 12 and 24 weeks after discontinuation of therapy (SVR12 and SVR24)
time frame: Posttreatment Weeks 12 and 24
Proportion of participants with HCV NS5B resistance associated variants among patients who do not achieve SVR at 12 weeks
time frame: Approximately 12 weeks after treatment completion or discontinuation

Eligibility Criteria

Male or female participants at least 18 years old.

Key Inclusion Criteria: - Adult patients with serogroup 2 (genotype 2) chronic HCV infection with or without compensated cirrhosis - Patients who are prescribed SOF+COPE Key Exclusion Criteria: Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Additional Information

Official title A Prospective Observational Post-Marketing Study of Sovaldi® Plus Copegus® in Japanese Patients With Chronic Genotype 2 Hepatitis C Virus Infection
Trial information was received from ClinicalTrials.gov and was last updated in November 2016.
Information provided to ClinicalTrials.gov by Gilead Sciences.