Safety and Efficacy of Albumin Interferon Administered Every 4 Weeks in Genotype 2/3 Hepatitis C Patients
- Conditions
- Health Condition 1: null- Chronic Hepatitis C
- Registration Number
- CTRI/2009/091/000148
- Lead Sponsor
- ovartis Healthcare Private Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 0
?Age of 18 years or older
?Clinical diagnosis of chronic hepatitis C
?Infection with HCV genotype 2 or 3
?No previous IFNα-based therapy
?Women of child-bearing potential if not using double barrier method of contraception, pregnant or nursing
?Fertile males, unless condom with spermicide is used and female partner agrees to use one or more of the acceptable methods until 7 months after last dose of RBV
?History or current evidence of decompensated liver disease; other forms of liver disease
?Coinfection with hepatitis B virus (HBV) or human immunodeficiency virus (HIV)
?History of moderate, severe or uncontrolled psychiatric disease
?History of seizure disorder
?History or clinical evidence of chronic cardiac disease, preexisting interstitial lung disease or severe lung disease
?Clinically significant findings on eye/retinal examination
?History of immunologically mediated disease
?Organ transplantation other than cornea or hair transplant
?History of clinically significant hemoglobinopathy
?Diagnosis of malignancy of any organ system with the exception of localized basal cell carcinoma of the skin
?History of galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption
?History of hypersensitivity to any of the study drugs or to drugs with similar chemical structures
?Drug or alcohol addiction within the last 6 months and/or positive drug screening tests
?Received systemic corticosteroids (prednisone equivalent of > 10 mg/day) within 14 days prior to Baseline visit
?Received concomitant systemic antibiotics, antifungals or antivirals for the treatment of active infection within 14 days prior to Baseline visit.
?Received herbal therapies (including milk thistle or glycyrrhizin) or an investigational drug within 35 days prior to Baseline visit
?Have a clinically significant laboratory abnormality
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method ?Adverse eventsTimepoint: at every visit
- Secondary Outcome Measures
Name Time Method ?Viral loadTimepoint: at weeks 4, 12 and 24 of treatment and 24 weeks post-treatment