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Grazoprevir/Elbasvir vs BOC/PR in Chronic HCV GT1
NCT02204475Phase 3
Key facts
- Status
- Withdrawn
- Start
- Nov 2014
- Primary completion
- Jun 2016
- Sponsor
- Merck & Co.
- Modality
- Small Molecules
- Drugs
- grazoprevirelbasvir
- Conditions
- hepatitis C (HCV)
01
Overview
Phase 3, randomised, open-label trial of grazoprevir and elbasvir in hepatitis C (HCV) (2 arms), sponsored by Merck & Co. Primary endpoint: Proportion of participants achieving Sustained Virologic Response 12 weeks after end of treatment. Planned start Nov 2014; status: withdrawn.
02
Design
2 arms- Study design
- RandomizedOpen-label
Grazoprevir/Elbasvir
Grazoprevir 100 mg + Elbasvir 50 mg QD for 12 weeks
BOC/PR
PR lead-in followed by BOC/PR for 24-44 weeks
03
Endpoints
Primary
Proportion of participants achieving Sustained Virologic Response 12 weeks after end of treatment
Secondary
Proportion of treatment-naive participants achieving SVR12
Number of participants experiencing an adverse event
Number of participants withdrawing from study treatment due to AEs
Proportion of prior treatment failure participants achieving SVR12
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