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Infliximab as Adjunct for Hepatitis C (PARTNER)
NCT00512278Phase 2
Key facts
- Status
- Completed
- Start
- Jul 2007
- Primary completion
- May 2012
- Countries
- 1
- Modality
- Monoclonal Antibodies
- Drugs
- infliximab
- Conditions
- hepatitis C (HCV)
01
Overview
Phase 2, randomised, double-blind trial in hepatitis C (HCV) comparing Infliximab Arm with Placebo Arm (2 arms). Primary endpoint: Sustained Virological Response at 72 weeks. Started Jul 2007; status: completed.
02
Design
2 arms- Study design
- RandomizedDouble-blind
Infliximab Arm
Infliximab + PEG-IFN alpha-2b + Ribavirin
Placebo Arm
Placebo + PEG-IFN alpha-2b + Ribavirin
03
Who it enrols
Treatment-naive patients with chronic Hepatitis C Genotype 1. Excludes patients with decompensated liver disease, HIV, Hepatitis B, or history of autoimmune hepatitis.
04
Endpoints
Primary
Sustained Virological Response
Secondary
Non-detectable HCV-RNA
Serious Adverse Events
Medically Significant Infections
05
Results
Not all primary endpoints met
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