Simtuzumab (GS-6624) in the Prevention of Progression of Liver Fibrosis in Subjects With Primary Sclerosing Cholangitis (PSC)
This study is currently recruiting participants.
Verified April 2014 by Gilead Sciences
Information provided by (Responsible Party):
First received: August 22, 2012
Last updated: April 7, 2014
Last verified: April 2014
The purpose of this study is to evaluate whether Simtuzumab (GS-6624) is effective at preventing the progression of liver fibrosis in subjects with PSC.
Primary Sclerosing Cholangitis (PSC)
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
|Official 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 Primary Sclerosing Cholangitis (PSC)|
Resource links provided by NLM:
Genetics Home Reference related topics: North American Indian childhood cirrhosis primary sclerosing cholangitisU.S. FDA Resources
Further study details as provided by Gilead Sciences:
Primary Outcome Measures:
- Change from baseline in morphometric quantitative collagen on liver biopsy [ Time Frame: Week 96 ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Safety data including adverse events, extent of exposure, laboratory evaluations, and immunogenicity [ Time Frame: Baseline to Week 96 plus 30 days ] [ Designated as safety issue: No ]Safety data collected will be summarized by treatment arm.
|Study Start Date:||February 2013|
|Estimated Study Completion Date:||May 2016|
|Estimated Primary Completion Date:||May 2016 (Final data collection date for primary outcome measure)|
Experimental: Treatment Arm A
Subject will receive subcutaneous injections of 75 mg of Simtuzumab (GS-6624) weekly for 96 weeks.
Other Name: GS-6624
Experimental: Treatment Arm B
Subject will receive subcutaneous injections of 125 mg of Simtuzumab (GS-6624) weekly for 96 weeks.
Other Name: GS-6624
Placebo Comparator: Treatment Arm C
Subject will receive subcutaneous injections of placebo weekly for 96 weeks.
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