GS-US-321-0102: GS-6624 in the Prevention of Progression of Liver Fibrosis in Subjects With With Primary Sclerosing Cholangitis (PSC)
Study Status
Open to Enrollment
Study Description
This clinical trial is for men and women with primary sclerosing cholangitis (PSC), a disease in which fibrosis, or scarring, occurs in the bile ducts of the liver. There are currently no treatment options for people with PSC other than liver transplantation, so new treatments are needed.
The experimental drug simtuzumab (also called GS-6624) is designed to help reverse the scarring process. The purpose of the study is to determine if simtuzumab is effective at preventing the progression of liver fibrosis in people with PSC.
Study participants will be randomly assigned to one of three treatment arms:
- Arm 1: 125mg of simtuzumab by self-injection
- Arm 2: 75mg of simtuzumab by self-injection
- Arm 3: placebo by self-injection (a placebo is an inactive substance that looks like simtuzumab but contains no medicine)
Participants will not know which treatment they are receiving. Two different doses of simtuzumab are being studied because it is not known what the best dose is.
Study staff will train participants to self-inject the study drug. Participants will self-inject simtuzumab/placebo once a week for 96 weeks (just under 2 years).
Disease Status and/or Stage
Primary Sclerosing Cholangtis (PSC)
Sponsor
Gilead
Key Eligibility
- Men and women age 18 to 65
- Primary Sclerosing Cholangitis (PSC)
- Chronic cholestatic liver disease of at least 6 months
- 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
Protocol ID
GS-US-321-0102
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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]
