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Simtuzumab in advanced liver fibrosis due to NASH
NCT01672866Phase 2
Key facts
- Status
- Terminated
- Start
- Dec 2012
- Primary completion
- Aug 2016
- Countries
- 9
- Sponsor
- Gilead Sciences
- Modality
- Monoclonal Antibodies
- Drugs
- simtuzumab
- Conditions
- Nonalcoholic steatohepatitis (NASH)Liver Fibrosis (LF)
01
Overview
Phase 2, randomised, double-blind trial of simtuzumab in Nonalcoholic steatohepatitis (NASH) and Liver Fibrosis (LF) (3 arms), sponsored by Gilead Sciences. Primary endpoints: Change From Baseline in Morphometric Quantitative Collagen on Liver Biopsy at 96 weeks and Event Free Survival at 240 weeks. Started Dec 2012; status: terminated.
02
Design
3 arms- Study design
- RandomizedDouble-blind
SIM 75 mg
Simtuzumab 75 mg SC weekly
SIM 125 mg
Simtuzumab 125 mg SC weekly
Placebo
Placebo SC weekly
03
Who it enrols
Adults with NASH and Stage 3-4 fibrosis (Ishak score) but without cirrhosis. Patients must have AST/ALT <= 10x ULN and creatinine < 2.0 mg/dL. Exclusion criteria include cirrhosis, hepatic decompensation, HCV/HBV infection, and recent weight reduction surgery.
04
Endpoints
Primary
Change From Baseline in Morphometric Quantitative Collagen on Liver Biopsy
Event Free Survival
05
Results
Not all primary endpoints met
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