Trials / Terminated
TerminatedNCT01672866
Safety and Efficacy of Simtuzumab (SIM, GS-6624) in Adults With Advanced Liver Fibrosis But Not Cirrhosis Secondary to Non-Alcoholic Steatohepatitis (NASH)
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 Molecule 2 (LOXL2), in Subjects With Advanced Liver Fibrosis But Not Cirrhosis Secondary to Non-Alcoholic Steatohepatitis (NASH)
- Status
- Terminated
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 222 (actual)
- Sponsor
- Gilead Sciences · Industry
- Sex
- All
- Age
- 18 Years – 65 Years
- Healthy volunteers
- Not accepted
Summary
The primary objective of this study is to evaluate whether SIM (formerly referred to as GS-6624) is effective at preventing the histologic progression of liver fibrosis and the clinical progression to cirrhosis in participants with NASH. It will consist of 2 phases: * Randomized Double-Blind Phase * Open-Label Phase (optional)
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | Placebo | Placebo to match SIM via subcutaneous injection every week |
| BIOLOGICAL | SIM | Subcutaneous injection every week |
Timeline
- Start date
- 2012-12-05
- Primary completion
- 2016-08-02
- Completion
- 2016-12-29
- First posted
- 2012-08-27
- Last updated
- 2019-03-27
- Results posted
- 2019-03-27
Locations
68 sites across 9 countries: United States, Belgium, Canada, France, Germany, Italy, Puerto Rico, Spain, United Kingdom
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT01672866. Inclusion in this directory is not an endorsement.