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|
|Actual Primary Completion Date :||July 2016|
|Actual 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01672853
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|Study Director:||Rob Myers, M.D.||Gilead Sciences|