Study to Investigate GS-7977 and Ribavirin for 24 Weeks in Subjects With Recurrent Chronic HCV Post Liver Transplant
This study is ongoing, but not recruiting participants.
Sponsor:
Gilead Sciences
Information provided by (Responsible Party):
Gilead Sciences
ClinicalTrials.gov Identifier:
NCT01687270
First received: September 12, 2012
Last updated: April 30, 2013
Last verified: April 2013
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Purpose
This is an open-label, single-arm study of GS-7977 and ribavirin (RBV) in subjects 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: GS-7977 Drug: Ribavirin |
Phase 2 |
Access to an investigational treatment associated with this study is available outside the clinical trial. More info ...
| 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 Hepatitis C Virus(HCV) Post Liver Transplant |
Resource links provided by NLM:
Further study details as provided by Gilead Sciences:
Primary Outcome Measures:
- 12 week antiviral efficacy after 24 weeks of treatment [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]Sustained virologic response 12 weeks after discontinuation of therapy (SVR12 defined as HCV RNA < lower limit of quantification(LLoQ) 12 weeks after last dose of study drug).
Secondary Outcome Measures:
- Evaluation of Safety and Tolerability after 24 weeks of treatment [ Time Frame: Safety and Tolerability on treatment and 30 days post last dose ] [ Designated as safety issue: No ]Assess safety laboratory tests and the number, frequency and severity of adverse events through 30 days post last dose of study drug
| Estimated Enrollment: | 40 |
| Study Start Date: | September 2012 |
| Estimated Study Completion Date: | October 2014 |
| Estimated Primary Completion Date: | February 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: GS-7977 and Ribavirin
GS-7977 400 mg once a day + Ribavirin(200-1200 mg/day, divided into doses taken twice a day) for 24 weeks.
|
Drug: GS-7977
Other Name: Sofosbuvir
Drug: Ribavirin
Other Name: RBV
|
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
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
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: | April 30, 2013 |
| Health Authority: | United States: Food and Drug Administration |
Additional relevant MeSH terms:
|
Hepatitis Hepatitis A Hepatitis, Chronic Hepatitis C Hepatitis C, Chronic Liver Diseases Digestive System Diseases Hepatitis, Viral, Human Virus Diseases Enterovirus Infections |
Picornaviridae Infections RNA Virus Infections Flaviviridae Infections Ribavirin Antiviral Agents Anti-Infective Agents Therapeutic Uses Pharmacologic Actions Antimetabolites Molecular Mechanisms of Pharmacological Action |
ClinicalTrials.gov processed this record on June 18, 2013