Safety and Efficacy of Sofosbuvir and Ribavirin in Adults With Recurrent Chronic Hepatitis C Virus (HCV) Post Liver Transplant

December 11, 2014 updated by: Gilead Sciences

A Phase 2, Multicenter, Open-Label Study to Investigate the Safety and Efficacy of GS-7977 and Ribavirin for 24 Weeks in Subjects With Recurrent Chronic HCV Post Liver Transplant

This is an open-label, single-arm study of sofosbuvir (GS-7977) and ribavirin (RBV) in adults who have had a liver transplant which has become re-infected with hepatitis C. The treatment period is 24 weeks with up to 48 weeks of follow up. The total time in this study will last up to 72 weeks not including the screening visit.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Phase 2

Expanded Access

Approved for sale to the public. See expanded access record.

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

  • France
      • Villejuif, France
  • Germany
    • Lower Saxony
      • Hannover, Lower Saxony, Germany
  • New Zealand
    • Auckland
      • Grafton, Auckland, New Zealand
  • Spain
      • Barcelona, Spain
  • United States
    • California
      • San Francisco, California, United States
    • Indiana
      • Indianapolis, Indiana, United States
    • Kansas
      • Kansas City, Kansas, United States
    • Massachusetts
      • Boston, Massachusetts, United States
    • Michigan
      • Ann Arbor, Michigan, United States
    • Minnesota
      • Rochester, Minnesota, United States
    • New York
      • New York, New York, United States, 10016
      • New York, New York, United States, 10032

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

Description

Inclusion Criteria:

  • Subjects with evidence of chronic HCV (all genotypes) documented pretransplantation
  • HCV RNA ≥ 10,000 IU/mL at screening
  • Absence of organ rejection as documented by post transplant liver biopsy taken no more than 12 months prior to baseline/Day 1 visit
  • Liver transplant ≥ 6 months and ≤ 12 years prior to screening
  • Naive to all nucleotide/nucleoside treatments for chronic HCV infection

Exclusion Criteria:

  • Multiorgan transplant that includes heart or lung recipient
  • Subjects with de novo or recurrent Hepatocellular Carcinoma(HCC) post transplant
  • Current use of corticosteroids at any dose > 5mg of prednisone/day (or equivalent dose of corticosteroid)
  • Infection with hepatitis B virus (HBV) or HIV at screening
  • Current, uncontrolled ascites, variceal hemorrhage, hepatic encephalopathy, hepatorenal syndrome, hepatopulmonary syndrome, or other signs of decompensated cirrhosis

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

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: SOF+RBV
Participants will receive sofosbuvir+RBV for 24 weeks.
Drug: Sofosbuvir
Sofosbuvir 400 mg tablet administered orally once daily
Other Names:
  • Sovaldi®
  • GS-7977
  • PSI-7977
Drug: RBV
Ribavirin (RBV) 200-mg tablet(s) administered orally in a divided daily dose starting at 400 mg, subsequently adjusted (range: 200 to 1200 mg in a divided daily dose) based upon a number of factors including hemoglobin value, creatinine clearance, and weight.
Other Names:
  • Ribasphere®

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of Participants With Sustained Virologic Response 12 Weeks After Discontinuation of Therapy (SVR12)
Time Frame: Posttreatment Week 12
SVR12 was defined as HCV RNA < the lower limit of quantitation (LLOQ; ie, < 25 IU/mL) 12 weeks following the last dose of study drug.
Posttreatment Week 12
Percentage of Participants Who Discontinue Study Drug Due to an Adverse Event
Time Frame: Baseline to Week 24
Baseline to Week 24

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of Participants With Sustained Virologic Response (SVR) at 4, 24, and 48 Weeks After Discontinuation of Therapy (SVR4, SVR24, and SVR48)
Time Frame: Posttreatment Weeks 4, 24, and 48
SVR4, SVR 24, and SVR 48 were defined as HCV RNA < LLOQ 4, 24, and 48 weeks following the last dose of study drug, respectively.
Posttreatment Weeks 4, 24, and 48
Percentage of Participants With HCV RNA < LLOQ at Weeks 12 and 24
Time Frame: Weeks 12 and 24
Weeks 12 and 24
HCV RNA and Change From Baseline at Weeks 2, 4, and 8
Time Frame: Baseline; Weeks 2, 4, and 8
Baseline; Weeks 2, 4, and 8
Percentage of Participants With Virologic Failure
Time Frame: Up to Posttreatment Week 24

Virologic failure was defined as on-treatment virologic failure or virologic relapse.

  • On-treatment virologic failure: HCV RNA < LLOQ during treatment with subsequent detectable HCV RNA while continuing treatment
  • Virologic relapse: HCV RNA < LLOQ at last observed on-treatment HCV RNA measurement and HCV RNA ≥ LLOQ after stopping treatment (2 consecutive HCV RNA measurements or last available HCV RNA measurement)
Up to Posttreatment Week 24

Collaborators and Investigators

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

Sponsor

Gilead Sciences

Investigators

  • Study Director: Jill M. Denning, MA, Gilead Sciences

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

November 1, 2012

Primary Completion (Actual)

December 1, 2013

Study Completion (Actual)

August 1, 2014

Study Registration Dates

First Submitted

September 12, 2012

First Submitted That Met QC Criteria

September 13, 2012

First Posted (Estimate)

September 18, 2012

Study Record Updates

Last Update Posted (Estimate)

December 19, 2014

Last Update Submitted That Met QC Criteria

December 11, 2014

Last Verified

December 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GS-US-334-0126
  • 2012-002417-19 (EudraCT Number)

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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