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Simeprevir vs Telaprevir in Hepatitis C Partial and Null Responders
NCT01485991Phase 3
Key facts
- Status
- Completed
- Start
- Feb 2012
- Primary completion
- Apr 2014
- Countries
- 24
- Sponsor
- Janssen Pharmaceutical
- Modality
- Reversible Covalent Inhibitors, Allosteric Modulators, Orthosteric Ligands
- Drugs
- simeprevir
- Conditions
- hepatitis C (HCV)
01
Overview
Phase 3, randomised, double-blind trial of simeprevir in hepatitis C (HCV) (2 arms), sponsored by Janssen Pharmaceutical. Primary endpoint: Sustained Virologic Response 12 Weeks After End of Treatment. Started Feb 2012; status: completed.
02
Design
2 arms- Study design
- RandomizedDouble-blind
Simeprevir Arm
Simeprevir + PegIFN + RBV for 12 weeks, then PegIFN + RBV for 36 weeks
Telaprevir Arm
Telaprevir + PegIFN + RBV for 12 weeks, then PegIFN + RBV for 36 weeks
03
Who it enrols
Adult patients with chronic HCV genotype 1 infection who failed prior peginterferon/ribavirin therapy (null or partial responders), with compensated liver disease and no HIV coinfection.
04
Endpoints
Primary
Sustained Virologic Response 12 Weeks After End of Treatment
Secondary
Sustained Virologic Response 24 Weeks After End of Treatment
Viral Relapse
05
Results
Not all primary endpoints met
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