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Simeprevir + Sofosbuvir in HCV Genotype 1 with Mild Decompensation
NCT02485080Phase 4
Key facts
- Status
- Withdrawn
- Start
- Sep 2015
- Primary completion
- Jan 2016
- Countries
- 1
- Sponsor
- Stanford University
- Modality
- Reversible Covalent Inhibitors, Allosteric Modulators, Orthosteric Ligands
- Drugs
- simeprevir
- Conditions
- hepatitis C (HCV)
01
Overview
Phase 4, open-label, single-arm trial of simeprevir in hepatitis C (HCV), sponsored by Stanford University. Primary endpoint: Sustained Virologic Response 12 weeks post-treatment. Planned start Sep 2015; status: withdrawn.
02
Design
1 arm- Study design
- Non-randomizedOpen-labelSingle group
Simeprevir + Sofosbuvir
Simeprevir 150 mg daily + Sofosbuvir 400 mg daily for 24 weeks
03
Who it enrols
Adult patients (18-72 years) with chronic HCV genotype 1 and cirrhosis (CPT score <= 6) who are IFN-intolerant or unwilling to take IFN. Excludes patients with uncontrolled decompensation (ascites, HE, varices), CPT >= 7, MELD > 10, HIV/HBV coinfection, or prior HCV protease inhibitor treatment.
04
Endpoints
Primary
Sustained Virologic Response 12 weeks post-treatment
Secondary
Serious Adverse Events
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