Alisporivir with pegIFN/RBV in protease inhibitor (PI) treatment failure patients with chronic hepatitis C

• Conditions: Chronic hepatitis C genotype 1 protease inhibitor (PI) treatment failure; MedDRA version: 14.1Level: LLTClassification code 10008912Term: Chronic hepatitis CSystem Organ Class: 10021881 - Infections and infestations; Therapeutic area: Diseases [C] - Virus Diseases [C02]

• Registration Number: EUCTR2011-004653-31-ES
• Lead Sponsor: ovartis Farmacéutica S.A

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-02-01
• Last Update Posted: 26 June 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 173

Inclusion Criteria

1. HCV GT1 patients with previous PI treatment failure. 2. Timing of the PI treatment. the minimum time from the last dose of previous PI treatment to the first dose of study medication is three months. 3. Diagnosed Chronic hepatitis C virus infection 4. Infection with HCV genotype 1
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 44
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 44

Exclusion Criteria

1. Use of other investigational drugs at the time of enrollment, 2. History of hypersensitivity to any pegIFN or RBV. 3. Any null non-responders to prior pegIFN/RBV treatment, Other protocol-defined inclusion/exclusion criteria may apply

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified