A research study of a new medicine, danoprevir (also known as RO5190591) with ritonavir (also known as NORVIR®) in combination with Pegasys® (also known as PEG-IFN alfa-2a) and Copegus® (also known as ribavirin) for the treatment of a disease called chronic hepatitis C which causes damage to the liver.
- Conditions
- Chronic Hepatitis CMedDRA version: 14.0Level: LLTClassification code 10008912Term: Chronic hepatitis CSystem Organ Class: 10021881 - Infections and infestationsTherapeutic area: Diseases [C] - Virus Diseases [C02]
- Registration Number
- EUCTR2010-019584-10-DE
- Lead Sponsor
- F.Hoffmann-La Roche
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 405
Inclusion Criteria
- Adults patients, >/=18 years of age
- Chronic Hepatitis C, Genotype 1 and 4
- HCV RNA >/=50,000 IU/mL
- treatment-naive
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 380
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 25
Exclusion Criteria
- Patients with cirrhosis or incomplete/transition to cirrhosis
- Patients with other forms of liver disease, HIV infection, hepatocellular carcinoma or severe cardiac disease
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method