Safety and Efficacy of Sofosbuvir and Ribavirin in Adults With Recurrent Chronic Hepatitis C Virus (HCV) Post Liver Transplant
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
2 other identifiers
interventional
40
5 countries
12
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Started Nov 2012
12 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 12, 2012
CompletedFirst Posted
Study publicly available on registry
September 18, 2012
CompletedStudy Start
First participant enrolled
November 1, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2014
CompletedResults Posted
Study results publicly available
December 19, 2014
CompletedDecember 19, 2014
December 1, 2014
1.1 years
September 12, 2012
December 11, 2014
December 11, 2014
Conditions
Outcome Measures
Primary Outcomes (2)
Percentage of Participants With Sustained Virologic Response 12 Weeks After Discontinuation of Therapy (SVR12)
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
Baseline to Week 24
Secondary Outcomes (4)
Percentage of Participants With Sustained Virologic Response (SVR) at 4, 24, and 48 Weeks After Discontinuation of Therapy (SVR4, SVR24, and SVR48)
Posttreatment Weeks 4, 24, and 48
Percentage of Participants With HCV RNA < LLOQ at Weeks 12 and 24
Weeks 12 and 24
HCV RNA and Change From Baseline at Weeks 2, 4, and 8
Baseline; Weeks 2, 4, and 8
Percentage of Participants With Virologic Failure
Up to Posttreatment Week 24
Study Arms (1)
SOF+RBV
EXPERIMENTALParticipants will receive sofosbuvir+RBV for 24 weeks.
Interventions
Sofosbuvir 400 mg tablet administered orally once daily
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Gilead Scienceslead
Study Sites (12)
Unknown Facility
San Francisco, California, United States
Unknown Facility
Indianapolis, Indiana, United States
Unknown Facility
Kansas City, Kansas, United States
Unknown Facility
Boston, Massachusetts, United States
Unknown Facility
Ann Arbor, Michigan, United States
Unknown Facility
Rochester, Minnesota, United States
Unknown Facility
New York, New York, 10016, United States
Unknown Facility
New York, New York, 10032, United States
Unknown Facility
Villejuif, France
Unknown Facility
Hanover, Lower Saxony, Germany
Unknown Facility
Grafton, Auckland, New Zealand
Unknown Facility
Barcelona, Barcelona, Spain
Related Publications (1)
Charlton M, Gane E, Manns MP, Brown RS Jr, Curry MP, Kwo PY, Fontana RJ, Gilroy R, Teperman L, Muir AJ, McHutchison JG, Symonds WT, Brainard D, Kirby B, Dvory-Sobol H, Denning J, Arterburn S, Samuel D, Forns X, Terrault NA. Sofosbuvir and ribavirin for treatment of compensated recurrent hepatitis C virus infection after liver transplantation. Gastroenterology. 2015 Jan;148(1):108-17. doi: 10.1053/j.gastro.2014.10.001. Epub 2014 Oct 7.
PMID: 25304641RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Clinical Trial Disclosures
- Organization
- Gilead Sciences, Inc.
Study Officials
- STUDY DIRECTOR
Jill M. Denning, MA
Gilead Sciences
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
- Expanded Access
- Yes
Study Record Dates
First Submitted
September 12, 2012
First Posted
September 18, 2012
Study Start
November 1, 2012
Primary Completion
December 1, 2013
Study Completion
August 1, 2014
Last Updated
December 19, 2014
Results First Posted
December 19, 2014
Record last verified: 2014-12