Randomized, Controlled Phase 2a/b Study of the Efficacy and Safety of PEG-rIL-29 Administered in Combination with Ribavirin to Treatment-Naive Subjects with Chronic Hepatitis C Virus Infection - ND
- Conditions
- Chronic Hepatitis C Virus Infection.MedDRA version: 9.1Level: SOCClassification code 10019805
- Registration Number
- EUCTR2009-011786-80-IT
- Lead Sponsor
- ZYMOGENETICS, INC.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 600
1. Males or females between the ages of 18 and 70 years, inclusive, at the time of signing informed consent. 2. No prior therapy for chronic HCV, other than up to 2 weeks of single-agent therapy with a direct-acting antiviral agent, including but not limited to, a protease or polymerase inhibitor. 3. Genotype 1, 2, 3, or 4 HCV RNA. [...]
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
1. Mixed genotype HCV infection. 2. Current or prior history of decompensated liver disease, including any of the following: current or prior history of encephalopathy of any grade, current or prior history of variceal bleeding, current or prior history of ascites, total serum bilirubin >1.5 mg/dL (unless due to Gilbert s disease), albumin <3.5 g/dL, or INR >1.2 3. Currently lactating or breast-feeding . [?]
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