Status:
COMPLETED
A Study of Ritonavir-Boosted Danoprevir (RO5190591) in Combination With Pegasys and Ribavirin in Patients With Chronic Hepatitis C Genotype 1
Lead Sponsor:
Hoffmann-La Roche
Conditions:
Hepatitis C, Chronic
Eligibility:
All Genders
18-65 years
Phase:
PHASE1
Brief Summary
This study will evaluate the efficacy, safety and tolerability of danoprevir (RO5190591) plus ritonavir as compared to danoprevir alone or placebo plus ritonavir in patients with chronic hepatitis C g...
Eligibility Criteria
Inclusion
- Adults, 18-65 years of age
- Chronic hepatitis C genotype 1
- HCV treatment naïve, or without sustained virologic response on prior PEG-INF/RBV treatment
- Body mass index (BMI) 18 - 35 kg/m2, inclusive; minimum weight 45 kg
Exclusion
- Liver cirrhosis
- Decompensated liver disease or impaired liver function
- Medical condition associated with chronic liver disease other than chronic hepatitis C
- Positive for hepatitis B or HIV infection at screening
- History of alcohol consumption exceeding 2 standard drinks per day when averaged over the course of a given week
Key Trial Info
Start Date :
August 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2012
Estimated Enrollment :
59 Patients enrolled
Trial Details
Trial ID
NCT01185860
Start Date
August 1 2009
End Date
January 1 2012
Last Update
November 2 2016
Active Locations (4)
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1
Montpellier, France, 34094
2
Christchurch, New Zealand, 8011
3
Grafton, New Zealand, 1010
4
Warsaw, Poland, 01-201