Clinical trial NCT01687270: Safety and Efficacy of Sofosbuvir and Ribavirin in Adults With Recurrent Chronic Hepatitis C Virus (HCV) Post Liver Transplant
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Recurrent Chronic Hepatitis C Virus
Post Liver Transplant
Lead sponsor: Gilead Sciences
Sponsor class: INDUSTRY
First posted: 2012-09-18
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility 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
* 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

Primary outcomes:
measure: Percentage of Participants With Sustained Virologic Response 12 Weeks After Discontinuation of Therapy (SVR12)
timeFrame: Posttreatment Week 12
measure: Percentage of Participants Who Discontinue Study Drug Due to an Adverse Event
timeFrame: Baseline to Week 24
Secondary outcomes:
measure: Percentage of Participants With Sustained Virologic Response (SVR) at 4, 24, and 48 Weeks After Discontinuation of Therapy (SVR4, SVR24, and SVR48)
timeFrame: Posttreatment Weeks 4, 24, and 48
measure: Percentage of Participants With HCV RNA < LLOQ at Weeks 12 and 24
timeFrame: Weeks 12 and 24
measure: HCV RNA and Change From Baseline at Weeks 2, 4, and 8
timeFrame: Baseline; Weeks 2, 4, and 8
measure: Percentage of Participants With Virologic Failure
timeFrame: Up to Posttreatment Week 24
Other outcomes:
Locations:
city: San Francisco
country: United States
state: California
city: Indianapolis
country: United States
state: Indiana
city: Kansas City
country: United States
state: Kansas
city: Boston
country: United States
state: Massachusetts
city: Ann Arbor
country: United States
state: Michigan
city: Rochester
country: United States
state: Minnesota
city: New York
country: United States
state: New York
city: New York
country: United States
state: New York
city: Villejuif
country: France
city: Hannover
country: Germany
state: Lower Saxony
city: Grafton
country: New Zealand
state: Auckland
city: Barcelona
country: Spain
Study officials:
affiliation: Gilead Sciences
name: Jill M. Denning, MA
role: STUDY_DIRECTOR
References:
citation: 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.