Chronic Hepatitis C. Chronic viral hepatitis C
Conditions
Interventions
Subcutaneous treatment with Alpha Interferon -2b (Pasture Made) Every other day plus oral treatment with ribavirin 10-15 mg/kg per day for 24 to 48 weeks according to the genotype of virus..
Treatment - Drugs
Subcutaneous treatment with Alpha Interferon -2b (Pasture Made) Every other day plus oral treatment with ribavirin 10-15 mg/kg per day for 24 to 48 weeks according to the genotype of virus.
Sponsors
Pasteur Institute of Iran (IPI)
Eligibility
Sex/Gender
All
Age
18 Years to 100 Years
Inclusion criteria
Inclusion criteria: 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 Exclusion Criteria: 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.
Exclusion criteria
Exclusion criteria:
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Rapid virologic response (RVR). Timepoint: 1 month after treatment initiation. Method of measurement: PCR. | — |
Secondary
| Measure | Time frame |
|---|---|
| Sustained virologic response (SVR). Timepoint: Every 3 months. Method of measurement: PCR. | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactMehrdad Nooranipour
Baqiyatallah Research Center for Gastroenterology and Liver Diseases
Outcome results
None listed