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Ravidasvir + Sofosbuvir in HCV Genotype 4
NCT02371408Phase 3
Key facts
- Status
- Unknown
- Start
- Jan 2015
- Primary completion
- Jan 2016
- Countries
- 1
- Sponsor
- Pharco Pharmaceuticals
- Modality
- Small Molecules
- Drugs
- ravidasvir
- Conditions
- hepatitis C (HCV)
01
Overview
Phase 3, randomised, open-label trial of ravidasvir in hepatitis C (HCV) (6 arms), sponsored by Pharco Pharmaceuticals. Primary endpoint: Sustained Virologic Response at 12 weeks post-treatment. Status: unknown.
02
Design
6 arms- Study design
- RandomizedOpen-label
Naive No RBV
Ravidasvir + Sofosbuvir for 12 weeks
Naive With RBV
Ravidasvir + Sofosbuvir + Ribavirin for 12 weeks
Exp Non-Cirrhotic No RBV
Ravidasvir + Sofosbuvir for 12 weeks
Exp Non-Cirrhotic With RBV
Ravidasvir + Sofosbuvir + Ribavirin for 12 weeks
Exp Cirrhotic 12w
Ravidasvir + Sofosbuvir + Ribavirin for 12 weeks
Exp Cirrhotic 16w
Ravidasvir + Sofosbuvir + Ribavirin for 16 weeks
03
Who it enrols
Adult patients with chronic HCV genotype 4 infection, treatment-naïve or interferon-experienced, with or without cirrhosis.
04
Endpoints
Primary
Sustained Virologic Response at 12 weeks post-treatment
Secondary
Sustained Virologic Response at 4 weeks post-treatment
Sustained Virologic Response at 24 weeks post-treatment
Proportion of treated study participants prematurely discontinuing study treatment
Proportion of patients experiencing treatment-emergent adverse events
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