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Vaniprevir + PegIFN/RBV in Japanese CHC Patients
NCT01405937Phase 3
Key facts
- Status
- Completed
- Start
- Aug 2011
- Primary completion
- Feb 2013
- Sponsor
- Merck & Co.
- Modality
- Small Molecules
- Drugs
- vaniprevir
- Conditions
- hepatitis C (HCV)
01
Overview
Phase 3, randomised, open-label trial of vaniprevir in hepatitis C (HCV) (2 arms), sponsored by Merck & Co. Primary endpoints: Sustained Virologic Response 24 Weeks After Completion of All Study Therapy, Adverse Events of Special Interest up to 48 weeks and 1 more. Started Aug 2011; status: completed.
02
Design
2 arms- Study design
- RandomizedOpen-label
Vaniprevir 12 Week Arm
12 weeks Vaniprevir + 24 weeks Peg-IFN/RBV
Vaniprevir 24 Week Arm
24 weeks Vaniprevir + 24 weeks Peg-IFN/RBV
03
Who it enrols
Japanese patients with compensated chronic hepatitis C genotype 1 who relapsed after prior interferon-based therapy. Excludes cirrhosis, HIV, and Hepatitis B coinfection.
04
Endpoints
Primary
Sustained Virologic Response 24 Weeks After Completion of All Study Therapy
Adverse Events of Special Interest
Discontinuation due to Adverse Event
Secondary
Sustained Virologic Response 12 Weeks After Completion of All Study Therapy
Rapid Virologic Response
Complete Early Virologic Response
Undetectable HCV RNA at End of Treatment
Mean Change From Baseline in HCV RNA
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