Efficacy and Safety of DEB025 Alone or Combined With Either Ribavirin or Peg-IFN α2a in Chronic Hepatitis C Genotype 2 and 3 naïve Patients
Phase 2
Completed
- Conditions
- Health Condition 1: null- Hepatitis C Chronic
- Registration Number
- CTRI/2010/091/002967
- Lead Sponsor
- ovartis HealthCare Pvt Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 340
Inclusion Criteria
Chronic hepatitis C viral
Plasma HCV RNA level lower limit ≥ 10000 IU/ml assessed by qPCR (quantitative polymerase chain reaction) or equivalent at screening; no upper limit;
HCV genotype 2 or 3;
No previous treatment for Hepatitis C infection
Exclusion Criteria
Patients with evidence of Cirrhosis at the time of screening.
Patients with evidence of Hepatocellular carcinoma at the time of screening.
Any other cause of relevant liver disease other than HCV.
4. ALT greater than or equal to 10 times ULN.
Other protocol-defined inclusion/exclusion criteria may apply
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method