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

June 23, 2017 updated by: Gilead Sciences

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

552

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Japan
      • Amagasaki-shi, Japan
      • Asahi-shi, Japan
      • Asahikawa-shi, Japan
      • Beppu-shi, Japan
      • Chichibu-shi, Japan
      • Fujioka-shi, Japan
      • Fukui-shi, Japan
      • Hamamatsu-shi, Japan
      • Iizuka-shi, Japan
      • Inzai-shi, Japan
      • Ishinomaki-shi, Japan
      • Iwaki-shi, Japan
      • Izunokuni-shi, Japan
      • Kahoku-gun, Japan
      • Kanazawa-shi, Japan
      • Kirishima-shi, Japan
      • Kisarazu-shi, Japan
      • Kitamoto-shi, Japan
      • Kobe-shi, Japan
      • Koshigaya-shi, Japan
      • Kure-shi, Japan
      • Moriguchi-shi, Japan
      • Nagakute-shi, Japan
      • Nagaoka-shi, Japan
      • Nagasaki-shi, Japan
      • Nagoya-shi, Japan
      • Nakagami-gun, Japan
      • Nanto-shi, Japan
      • Nishinomiya-shi, Japan
      • Ogi-shi, Japan
      • Okayama-shi, Japan
      • Ome-shi, Japan
      • Osaka-shi, Japan
      • Ota-ku, Japan
      • Sapporo-shi, Japan
      • Sasebo-Shi, Japan
      • Sendai-shi, Japan
      • Shinagawa-ku, Japan
      • Shinjuku-ku, Japan
      • Tokorozawa-shi, Japan
      • Tokushima-shi, Japan
      • Wakayama-shi, Japan
      • Yachiyo-shi, Japan
      • Yokohama-shi, Japan
      • Yufu-shi, Japan

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Adult patients with serogroup 2 (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.

Description

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:

  • None

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Ecologic or Community
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
SOF+COPE
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.
Drug: SOF
SOF 400 mg tablets administered orally once daily
Other Names:
  • Sovaldi®
  • GS-7977
  • PSI-7977
Drug: COPE
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)
Other Names:
  • Ribavirin
  • Copegus®

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Incidence of adverse drug reaction (ADR) under real world settings
Time Frame: Up to 16 weeks
Up to 16 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
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
Approximately 12 weeks after treatment completion or discontinuation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Gilead Sciences

Collaborators

Chugai Pharmaceutical

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 15, 2015

Primary Completion (Actual)

June 5, 2017

Study Completion (Actual)

June 5, 2017

Study Registration Dates

First Submitted

August 28, 2015

First Submitted That Met QC Criteria

August 28, 2015

First Posted (Estimate)

September 1, 2015

Study Record Updates

Last Update Posted (Actual)

June 27, 2017

Last Update Submitted That Met QC Criteria

June 23, 2017

Last Verified

June 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GS-US-334-1444 / COPE1501

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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