Phase IIb - GS-6624 in subjects with advanced liver fibrosis
Research type
Research Study
Full title
A Phase 2b, Dose-Ranging, Randomized, Double-Blind, Placebo-Controlled Trial Evaluating the Safety and Efficacy of GS-6624, a Monoclonal Antibody Against Lysyl Oxidase-Like 2 (LOXL2), in Subjects with Advanced Liver Fibrosis but not Cirrhosis Secondary to Non-Alcoholic Steatohepatitis (NASH)
IRAS ID
116280
Contact name
w rosenberg
Sponsor organisation
Gilead Sciences Inc.
Eudract number
2012-002488-88
Clinicaltrials.gov Identifier
Research summary
Non-Alcoholic Steatohepatitis (NASH) is a disease that results when fat accumulates in the liver. The body??s immune system responds to the fat by attacking the liver cells. In time, enough liver cells are damaged that fibrosis (scar tissue) is formed within the liver where the healthy cells used to be. Currently there are no licensed drug treatments available for NASH.The experimental drug GS-6624 is being developed by Gilead Sciences, Inc. to treat many different fibrotic diseases including liver fibrosis. The purpose of this study is to see if GS-6624 is effective at preventing the progression of liver fibrosis in people with advanced liver fibrosis.About 225 participants from approximately 50 sites all over the world will be recruited into this study. Approximately 10 participants will be recruited in the UK, but enrolment is competitive and the number of participants is not capped.Taking part in this study will last about 100 weeks not including the screening visit which can last up to eight weeks. During this time, participants will be required to visit the clinic at least 28 times. Participants will be randomly selected by chance to receive one of three treatments: ?½ 75mg GS-6624 by self-injection or?½ 125mg GS-6624 by self-injection or ?½ Placebo (dummy drug) by self-injection The study is made up of the following parts:?½ Screening: One or more visits to the Study Doctor. The screening may last up to 8 weeks before the study drug is given.?½ Treatment Phase: Weekly self-injection of GS-6624 or placebo every week for 96 weeks for a total of 96 injections.?½ Follow-up: One visit to the Study Doctor 4 weeks following the end of the Treatment Phase (Week 96).Procedures included: medical history, physical examination, vital signs, urine tests, blood tests, liver biopsy, Liver Stiffness Imaging by Ultrasound and / or magnetic resonance elastography (MRE).
REC name
London - Westminster Research Ethics Committee
REC reference
13/LO/0097
Date of REC Opinion
4 Feb 2013
REC opinion
Favourable Opinion