Short term Efficacy and Safety of Alpha Interferon -2b (Pasture Made) plus Ribavirin for Treatment of the Patients with Chronic Hepatitis C
- Conditions
- Chronic Hepatitis C.Chronic viral hepatitis C
- Registration Number
- IRCT138812123307N4
- Lead Sponsor
- Pasteur Institute of Iran (IPI)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 100
Inclusion Criteria: Impossibility for administration of peg-interferon according to recommendation of relevant specialist, older than 18 years, HCV RNA in serum on polymerase-chain-reaction (PCR) assay
decompensated cirrhosis, autoimmune disease, evidence of cancer on ultrasonography or a high serum alfa-fetoprotein concentration, co-infection with HBV or HIV, neutropenia (neutrophil count <1500 cells/mm3), thrombocytopenia (platelet count <90,000 cells/mm3), anemia (hemoglobin level <12 gr/dl for women and <13 gr/dl for men), creatinine concentration more than 1.5 times the upper limit of normal range, organ transplantation, neoplastic disease, severe cardiac or chronic pulmonary disease, poorly controlled psychiatric disorder, seizure disorder, retinopathy, active drug or alcohol abuse, pregnancy in patient or spouse or unwillingness to use contraception.
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Rapid virologic response (RVR). Timepoint: 1 month after treatment initiation. Method of measurement: PCR.
- Secondary Outcome Measures
Name Time Method Sustained virologic response (SVR). Timepoint: Every 3 months. Method of measurement: PCR.