GS-US-321-0105: GS-6624 in the Treatment of Liver Fibrosis in Subjects With Advanced Liver Fibrosis But Not Cirrhosis Secondary to Non-Alcoholic Steatohepatitis (NASH)
Study Status
Open to Enrollment
Study Description
This clinical trial is for men and women with advanced liver fibrosis as a result of NASH (non-alcoholic steatohepatitis). NASH is a disease that results when fat accumulates in the liver; the body’s immune system responds by attacking liver cells which in time causes fibrosis (scar tissue). When enough scarring is present, the liver is said to be cirrhotic. Currently, no treatment exists for reversing liver fibrosis and preventing cirrhosis due to NASH other than liver transplantation, so new treatments are needed.
GS-6624 is an experimental drug designed to help reverse the scarring process. The purpose of this study is to determine if GS-6624 can reverse advanced fibrosis in the liver and prevent cirrhosis.
Study participants will be randomly assigned to one of three treatment arms:
- Arm 1: 125mg of GS-6624
- Arm 2: 75mg of GS-6624
- Arm 3: placebo (a blank substance that looks like GS-6624 but does not contain any medicine)
In each arm, participants will self-inject the study drug/placebo once a week for 95 weeks, followed by an 8-week follow-up. Study participants will not know which treatment they are receiving.
Total study participation will last about 108 weeks, or about 2 years. Participants will be compensated for their time at each study visit.
Disease Status and/or Stage
Advanced Liver Fibrosis as a Result of NASH (non-lcoholic steatohepatitis)
Sponsor
Gilead
Key Eligibility
- Men and women age 18 to 65
- Chronic liver disease due to NASH with advanced fibrosis but not cirrhosis
- Liver disease due to viral hepatitis or alcoholic liver disease not eligible
- Detailed eligibility reviewed when you contact the study team
Principal Investigator
Contact
- Hepatitis Research Team
- (646) 962-HEPC (4372)
- Gastroenterology Medical Practice
- (646) 962-4463
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Contact Us
For general inquiries, or if you need assistance finding a study, please contact:
Robert Hagerty
Subject Recruitment Manager
Tel: (646) 962-9340
[email protected]
