Simtuzumab (GS-6624) in the Prevention of Progression of Liver Fibrosis in Subjects With Primary Sclerosing Cholangitis (PSC)
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|ClinicalTrials.gov Identifier: NCT01672853|
Recruitment Status : Completed
First Posted : August 27, 2012
Last Update Posted : February 24, 2017
|Condition or disease||Intervention/treatment||Phase|
|Primary Sclerosing Cholangitis (PSC)||Biological: Simtuzumab Biological: Placebo||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||235 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Investigator, Outcomes Assessor)|
|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)|
|Study Start Date :||February 2013|
|Primary Completion Date :||July 2016|
|Study Completion Date :||August 2016|
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.
- Change from baseline in morphometric quantitative collagen on liver biopsy [ Time Frame: Week 96 ]
- Safety data including adverse events, extent of exposure, laboratory evaluations, and immunogenicity [ Time Frame: Baseline to Week 96 plus 30 days ]Safety data collected will be summarized by treatment arm.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01672853
Show 75 Study Locations
|Study Director:||Rob Myers, M.D.||Gilead Sciences|