GS-US-337-0124: Sofosbuvir/Ledipasvir Fixed-Dose Combination+Ribavirin
Research type
Research Study
Full title
A Phase 2, Multicenter, Open-Label Study to Investigate the Safety and Efficacy of Sofosbuvir/Ledipasvir Fixed-Dose Combination + Ribavirin Administered in Subjects Infected with Chronic HCV who have Advanced Liver Disease or are Post-Liver Transplant
IRAS ID
144748
Contact name
David Mutimer
Contact email
Sponsor organisation
Gilead Sciences, Inc.
Eudract number
2013-002802-30
ISRCTN Number
NA
Clinicaltrials.gov Identifier
NA
Research summary
This is a Phase 2, randomised, open-label study, sponsored by Gilead Sciences. It involves a new experimental fixed-dose combination (FDC) pill, called Sofosbuvir/ledipasvir (SOF/LDV) FDC, with ribavirin (RBV), for the treatment of chronic hepatitis C virus (HCV) infection in subjects with advanced liver disease or who are post-liver transplantation.
The purpose of this study is to see if SOF/LDV FDC + RBV are effective in treating subjects infected with the HCV with genotypes 1 and 4, who have advanced liver disease with permanent liver damage (cirrhosis) and may be showing signs of liver failure or who have undergone liver transplantation, as well as to evaluate the safety and tolerability of SOF/LDV FDC + RBV in these patients.
Dependent upon the stage of the liver disease, patients will be categorised into one of two cohorts, A or B.
Cohort A, subjects with advanced liver disease but have not had a liver transplant. This will include approximately 50 subjects in 2 groups, (1 & 2) where patients would be categorised depending upon the status of hepatic impairment as to moderate or severe.
Cohort B subjects must have already had a liver transplant and they will further be grouped in 5 groups (group 3 (100 subjects), group 4 to 7(each 50 subjects approximately) depending upon the level of cirrhosis and level of hepatic impairment.
The study includes screening up to 6 weeks, Study drug treatment 12 or 24 weeks that includes 13 or 15 visits lasting 1 to 2 hours each and Follow-Up visits up to 24 weeks after last dose of study drug; includes up to 5 visits lasting 1 to 2 hours each (Post-treatment and Post-transplant schedule of assessments are the same).
The Study will involve a total of 400 subjects at approximately 34 study sites in Europe, Canada, Australia, and New Zealand.
REC name
East Midlands - Derby Research Ethics Committee
REC reference
14/EM/0017
Date of REC Opinion
27 Jan 2014
REC opinion
Further Information Favourable Opinion