A research study of a new medicine, danoprevir, with ritonavir andCopegus (also known as ribavirin), in combination with another newmedicine, RO5024048, and/or Pegasys for the treatment of a diseasecalled chronic hepatitis C, which causes damage to the liver, in patientsthat failed a previous treatment for hepatitis C.
- 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
- EUCTR2010-019585-90-ES
- Lead Sponsor
- F.Hoffmann-La Roche
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 420
- 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 395
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 25
- 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
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method