Health Condition 1: B182- Chronic viral hepatitis C
Conditions
Interventions
Intervention1: PEG-Inferon: Genotypes 1 and 4: PEG-Inferon 1.5 µg/kg body weight/wk subcutaneously + Ribavirin (800 mg/day for �65 kg
1400 mg/day for 105 kg) orally.
Genotypes 2 and 3: PEG-Inferon 1.5 µg/kg body weight/wk subcutaneously + Ribavirin 800 mg/day orally.
The duration of therapy for genotype 1 and 4 is 48 weeks and for
Sponsors
Virchow Biotech Pvt Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 1. Adult male or female between 18-65 years (both years inclusive). 2. Patient with chronic hepatitis C infection. 3. Presence of serum alanine aminotransferase (ALT) levels 1.5 times greater than normal (N 4. Compensated liver disease at the time of baseline visit as defined by Child-Pugh class A. 5. Hemoglobin >=9 g/dL (females), >=10 g/dL (males); platelet count >=75 Ã? 109/L; neutrophil count >=1.5 Ã? 109/L; thyroid stimulating hormone (TSH) within normal limits (0.35 â?? 5.50 mIU/mL). 6. Willing to give written informed consent and adhere to study visit schedule
Exclusion criteria
Exclusion criteria: 1. Any evidence of other liver diseases HAV, HBV, HDV, alpha 2 anti-trypsin deficiency, Wilsonâ??s disease, primary biliary cirrhosis, alcoholic liver disease or autoimmune liver disease, hemochromatosis. 2. A chronic alcoholic or patient with drug abuse problem or severe psychiatric condition. 3. Pregnant or intent to be pregnant during the study period or nursing mothers. 4. Patient with immune suppression associated with organ transplantation especially liver transplantation. 5. History of hypersensitivity to interferon or its diluents. Significant psychiatric disease especially depression. 6. Severe cardiovascular disease. 7. Patient with human immunodeficiency virus (HIV) infection.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Percentage of patients with sustained virological response (defined as undetectable serum HCV RNA 24 weeks after cessation of therapy).Timepoint: at 72 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| 2. Percentage of patients with normalisation of ALT at 12, 24 weeks and 48 weeks and 24 weeks after cessation of therapy.Timepoint: at 12, 24 weeks and 48 weeks;Percentage of patients with undetectable serum HCV RNA at 12, 24 weeks and at 48 weeksTimepoint: at 12, 24 weeks and at 48 weeks | — |
Countries
India
Contacts
Public ContactDr Hemanth Nandigala
Virchow Biotech Private Limited
Outcome results
None listed