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Boceprevir vs Telaprevir in Chronic Hepatitis C
NCT02113631Phase 4
Key facts
- Status
- Completed
- Start
- Sep 2011
- Primary completion
- Apr 2013
- Countries
- 1
- Sponsor
- Louis Stokes Cleveland Department of Veterans Affairs Medical Center
- Modality
- Orthosteric Ligands
- Drugs
- boceprevirtelaprevir
- Conditions
- hepatitis C (HCV)
01
Overview
Phase 4, randomised, open-label trial in hepatitis C (HCV) comparing Telaprevir Arm with Boceprevir Arm (2 arms). Primary endpoint: Safety/Adverse Event Outcome Measure up to 3 weeks. Started Sep 2011; status: completed.
02
Design
2 arms- Study design
- RandomizedOpen-label
Telaprevir Arm
Telaprevir + Peg-IFN + Ribavirin
Boceprevir Arm
Boceprevir + Peg-IFN + Ribavirin
03
Who it enrols
Adult patients with chronic hepatitis C genotype 1 infection, including those with compensated cirrhosis and prior treatment failures. Excludes patients with HIV, Hepatitis B, severe psychiatric disorders, or recent malignancy.
04
Endpoints
Primary
Safety/Adverse Event Outcome Measure
Secondary
Resource use
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