A Randomized, Open-label, Multicenter Study to Evaluate the Sustained Virologic Response of the HCVProtease Inhibitor Danoprevir Boosted with Low Dose Ritonavir (Danoprevir/r) and Copegus, inCombination with the HCV Polymerase Inhibitor Prodrug RO5024048 and/or Pegasys in ChronicHepatitis C Genotype 1 Patients Who Failed with a Previous Course of Peginterferon alfa plus RibavirinCombination Therapy - Matterhor

• Conditions: Chronic Hepatitis C; MedDRA version: 13.1Level: LLTClassification code 10008912Term: Chronic hepatitis CSystem Organ Class: 10021881 - Infections and infestations

• Registration Number: EUCTR2010-019585-90-IT
• Lead Sponsor: F.Hoffmann-La Roche

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2011-05-18
• Last Update Posted: 25 March 2013

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 420

Inclusion Criteria

Adult patients, age 18 years and older
- Presence of hepatitis C infection, genotype 1a or 1b
- Documentation of previous treatment failure after receiving approved doses of peginterferon plus ribavirin for at
least 12 weeks
- Patients must have discontinued prior hepatitis C treatment at least 12 weeks prior to study start
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
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

- Infection with any hepatitis C genotype or subtype other than genotype 1a or 1b
- Patients with cirrhosis
- Patients who were discontinued from previous peginterferon plus ribavirin therapy due to reasons other than
insufficient therapeutic response
- Co-infection with hepatitis B or human immunodeficiency virus (HIV)
- History or evidence of chronic liver disease other than hepatitis C

Study & Design

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