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Metformin for Liver Fibrosis in HCV Patients With Insulin Resistance
NCT02306070Phase 2
Key facts
- Status
- Withdrawn
- Start
- Jan 2016
- Primary completion
- Sep 2017
- Countries
- 1
- Sponsor
- Ottawa Hospital Research Institute
- Modality
- Small Molecules
- Drugs
- metformin
- Conditions
- Liver Fibrosis (LF)hepatitis C (HCV)
01
Overview
Phase 2, randomised, open-label trial of metformin in Liver Fibrosis (LF) and hepatitis C (HCV) (2 arms), sponsored by Ottawa Hospital Research Institute. Primary endpoint: Change in FibroScan score at 12 weeks. Planned start Jan 2016; status: withdrawn.
02
Design
2 arms- Study design
- RandomizedOpen-label
Metformin + lifestyle modification
Metformin + lifestyle modification pre, during and post HCV antiviral therapy
No Metformin + Lifestyle modification
No metformin + lifestyle modification pre, during and post HCV antiviral therapy
03
Who it enrols
HCV-infected patients (with or without HIV) intending to start IFN-free HCV antiviral therapy, with insulin resistance and evidence of liver fibrosis, excluding those with pre-existing diabetes or decompensated cirrhosis.
04
Endpoints
Primary
Change in FibroScan score
Secondary
Sustained Virological Response
AST to Platelet Ratio Index
Change in glucose metabolism
Change in lipid levels
Change in anthropometric measures
Change in liver-related inflammatory markers
Alpha-fetoprotein levels
Participant acceptability to study medication dosing
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