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Completed

NCT Number: NCT02562742

Use-Results Surveillance Study of Sovaldi® Plus Rebetol® in Japanese Patients With Chronic Genotype 2 Hepatitis C Virus Infection

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.

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Key information

Conditions

Hepatitis C Blood-Borne Infections Communicable Diseases Digestive System Diseases Flaviviridae Infections Hepatitis Hepatitis, Viral, Human Infections Liver Diseases RNA Virus Infections Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Ageo-shi, Japan

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Key Inclusion Criteria:

  • Adult patients with serogroup 2 (genotype 2) chronic HCV infection with or without compensated cirrhosis
  • Patients who are prescribed SOF+REB

Key Exclusion Criteria:

  • None

Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Treatment and study plan

SOF

Drug

SOF 400 mg tablets administered orally once daily

Other names: Sovaldi®, GS-7977, PSI-7977

REB

Drug

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)

Other names: Rebetol®, Ribavirin

Primary outcomes

  1. Incidence of adverse drug reaction (ADR) under real world settings

    Time frame: Up to 16 weeks

Secondary outcomes

  1. 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

    SVR12 and SVR24 are defined as HCV RNA < the lower limit of quantification (LLOQ) 12 and 24 weeks following the last dose of study drug, respectively.

  2. 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

Sponsors and collaborators

Lead sponsor

Gilead Sciences

Industry

Collaborators

  • Merck Sharp & Dohme LLC

Registry information

Official study title

A Prospective Observational Post-Marketing Study of Sovaldi® Plus Rebetol® in Japanese Patients With Chronic Genotype 2 Hepatitis C Virus Infection

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
Sep 29, 2015
Registry last updated
Aug 1, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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