A Study of GS9190 in combination with PEG & RIBA in treatment of HCV
Research type
Research Study
Full title
A Phase 2b, Randomized, Double-Blind, Placebo-Controlled Trial Comparing 24 or 48 Weeks of GS-9190, in Combination with Peginterferon Alfa 2a and Ribavirin, to 48 Weeks of Peginterferon Alfa 2a and Ribavirin for the Treatment of Genotype-1 Chronic Hepatitis C Virus (HCV) Infection
IRAS ID
7404
Contact name
Graham R Foster
Sponsor organisation
Gilead Sciences, Inc.
Eudract number
2008-004527-31
Clinicaltrials.gov Identifier
Research summary
An estimated 170 million patients worldwide are chronically infected with Hepatitis C virus (HCV), the impact of HCV on morbidity, mortality and associated health-care costs is tremendous. In the US HCV infection accounts for approximately 40-60% of all chronic liver disease, is the primary reason for liver transplantation and results in about 10,000 to 12,000 deaths each year. Treatment with peginterferon alfa 2a (PEG) and ribavirin (RIBA) is the current standard of care for chronic hepatitis C virus (HCV) infection however there is a significant percentage of patients who do not respond to this treatment. There are currently no approved treatment alternatives to PEG and RIBA. This study will compare using the experimental drug GS-9190 with PEG and RIBA or using only PEG and RIBA for treatment of chronic HCV infection. The study has recruited 252 subjects from 65 study sites in the United States and Europe. Subject recruitment ended in April 2009. Each subject's total participation will last 72 weeks (approximately 1.5 years), during which time they will be required to come to the clinic for up to 21 study visits. Following the Week 72 visit, ongoing participants who meet lab eligibility criteria will enter the long-term (3 year) follow-up registry sub-study for continued monitoring of their virus level to confirm it remains undetectable.At every visit specific assessments will be performed including physical exams, vital signs (blood pressure, respiration rate and temperature), blood and urine samples will be collected and a pregnancy test will be done for females capable of having children. Participants will be asked questions regarding medical history, medications taken and any illness/complaints they may have had since starting the study drug.An external independent Data Monitoring Committee (DMC) will periodically review the progress and safety of the study in order to protect participant welfare and preserve study integrity. The DMC will provide recommendations as needed regarding study design and conduct.
REC name
London - Fulham Research Ethics Committee
REC reference
08/H0711/105
Date of REC Opinion
12 Dec 2008
REC opinion
Further Information Favourable Opinion