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Mericitabine + SOC in Treatment-Naïve HCV Genotype 1 or 4
NCT00869661Phase 2
Key facts
- Status
- Completed
- Start
- Feb 2001
- Primary completion
- Feb 2012
- Countries
- 10
- Sponsor
- Roche
- Modality
- Small Molecules
- Drugs
- mericitabine
- Conditions
- hepatitis C (HCV)
01
Overview
Phase 2, randomised, double-blind trial of mericitabine in hepatitis C (HCV) (6 arms), sponsored by Roche. Primary endpoint: Sustained Virologic Response. Started Feb 2001; status: completed.
02
Design
6 arms- Study design
- RandomizedDouble-blind
Mericitabine 500mg bid + SOC (12w)
Mericitabine 500mg bid + SOC for 12 weeks, then SOC for 12 weeks. RGT at week 24.
Mericitabine 1000mg bid + SOC (8w)
Mericitabine 1000mg bid + SOC for 8 weeks, then SOC for 16 weeks. RGT at week 24.
Mericitabine 1000mg bid + SOC (12w)
Mericitabine 1000mg bid + SOC for 12 weeks, then SOC for 12 weeks. RGT at week 24.
Mericitabine 1000mg bid + SOC (12w) Fixed
Mericitabine 1000mg bid + SOC for 12 weeks, then SOC for 36 weeks.
SOC Control
SOC (Pegasys + Copegus) for 48 weeks.
Retreatment
Mericitabine + SOC for 24 weeks, then SOC for 24 weeks. For Group 5 failures.
03
Who it enrols
Adult patients with chronic hepatitis C genotype 1 or 4 who are treatment-naive.
04
Endpoints
Primary
Sustained Virologic Response
Secondary
Virologic Response
Virologic Response Post-Treatment
Relapse Rate
Incidence of Adverse Events
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