Safety of Efficacy of Sofosbuvir (GS-7977) and Ribavirin in Adults With Recurrent Chronic Hepatitis C Virus (HCV) Post Liver Transplant

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Gilead Sciences
ClinicalTrials.gov Identifier:
NCT01687270
First received: September 12, 2012
Last updated: August 28, 2014
Last verified: August 2014
  Purpose

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.


Condition Intervention Phase
Recurrent Chronic Hepatitis C Virus
Post Liver Transplant
Drug: Sofosbuvir
Drug: RBV
Phase 2

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Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Gilead Sciences:

Primary Outcome Measures:
  • Proportion of participants with sustained virologic response 12 weeks after discontinuation of therapy (SVR12) [ Time Frame: Posttreatment Week 12 ] [ Designated as safety issue: No ]
    SVR12 is defined as HCV RNA < the lower limit of quantitation (LLOQ; ie, < 25 IU/mL) 12 weeks following the last dose of study drug.

  • Proportion of participants who discontinue study drug due to an adverse event [ Time Frame: Baseline to Week 24 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Proportion of participants with sustained virologic response (SVR) at 4, 24, and 48 weeks after discontinuation of therapy (SVR2, SVR4, SVR8, and SVR24) [ Time Frame: Posttreatment Weeks 4, 24, and 48 ] [ Designated as safety issue: No ]
  • Proportion of participants who have HCV RNA < LLOQ by visit while on treatment [ Time Frame: Baseline to Week 24 ] [ Designated as safety issue: No ]
  • Absolute and change from baseline in HCV RNA through Week 8 [ Time Frame: Baseline to Week 8 ] [ Designated as safety issue: No ]
  • Proportion of participants with virologic failure [ Time Frame: Baseline to posttreatment Week 48 ] [ Designated as safety issue: No ]
    Virologic failure is defined as virologic breakthrough (participant achieved undetectable HCV RNA levels during treatment but subsequently had detectable HCV RNA while continuing treatment), non-response (HCV RNA ≥ LLOQ through 24 weeks of treatment), or relapse (participant achieved undetectable HCV RNA levels during treatment maintained undetectable HCV RNA for the duration of treatment or achieved undetectable HCV RNA within 4 weeks of the end of treatment but did not achieve SVR at 4, 24, and 48 weeks posttreatment).


Enrollment: 40
Study Start Date: November 2012
Study Completion Date: August 2014
Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Sofosbuvir+RBV
Participants will receive sofosbuvir+RBV for 24 weeks.
Drug: Sofosbuvir
Sofosbuvir 400 mg tablet administered orally once daily
Other Names:
  • GS-7977
  • PSI-7977
  • Sovaldi®
Drug: RBV
Ribavirin (RBV) 200-mg tablet(s) administered orally in two divided daily doses. RBV dosing (200-1200) will be determined and adjusted according to participants' hemoglobin value, creatinine clearance, and weight.
Other Name: Ribasphere®

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  • Naïve to all nucleotides/nucleoside treatments for chronic HCV infection

Exclusion Criteria:

  • Multi-organ 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 human immunodeficiency virus (HIV) at screening
  • Current, uncontrolled ascites, variceal hemorrhage, hepatic encephalopathy, hepatorenal syndrome, hepatopulmonary syndrome, or other signs of decompensated cirrhosis
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01687270

Locations
United States, California
San Francisco, California, United States
United States, Indiana
Indianapolis, Indiana, United States
United States, Kansas
Kansas City, Kansas, United States
United States, Massachusetts
Boston, Massachusetts, United States
United States, Michigan
Ann Arbor, Michigan, United States
United States, Minnesota
Rochester, Minnesota, United States
United States, New York
New York, New York, United States, 10032
New York, New York, United States, 10016
France
Villejuif, France
Germany
Hannover, Lower Saxony, Germany
New Zealand
Grafton, Auckland, New Zealand
Spain
Barcelona, Spain
Sponsors and Collaborators
Gilead Sciences
Investigators
Study Director: Jill M. Denning, MA Gilead Sciences
  More Information

No publications provided

Responsible Party: Gilead Sciences
ClinicalTrials.gov Identifier: NCT01687270     History of Changes
Other Study ID Numbers: GS-US-334-0126, 2012-002417-19
Study First Received: September 12, 2012
Last Updated: August 28, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Hepatitis C
Hepatitis, Chronic
Hepatitis C, Chronic
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Flaviviridae Infections
Ribavirin
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on October 19, 2014