Efficacy of Pegylated Interferon Alone in Egyptian Patients With Acute Hepatitis C (ANRS 1213)
Hepatitis C
About this trial
This is an interventional treatment trial for Hepatitis C focused on measuring Acute hepatitis C, Genotype 4, Pegylated Interferon, Egypt
Eligibility Criteria
Inclusion Criteria: Acute hepatitis C:(1)ALT over 3x normal values ; IgM anti-HAV, IgM anti-HBc negative antibody ; negative HCV antibodies (3rd generation ELISA) and positive HCV PCR at first presentation, or, (2)ALT over 4x normal values ; IgM anti-HAV, IgM anti-HBc, CMV, EBV and toxoplasmoses negative antibody and negative HEV PCR ; Positive HCV antibodies (3rd generation ELISA) and positive HCV PCR at first presentation ; a clear history of exposure within 2 months prior the time of diagnosis ; no exposure to hepatotoxic drug or pesticide within 2 weeks prior the time of diagnosis Patients without chronic liver disease HBsAg negative Hemoglobin over or equal to 11g/dl Leucocytes over or equal to 3000/mm3 Polynuclear neutrophils over or equal to 1500/mm3 Platelets over or equal to 100 000/mm3 Blood creatinin less or equal to 150 micromol/l Blood uric acid within the normal limits of the investigating center Normal TSH Antinuclear antibodies < 1/160 Fasting blood sugar 70-115 mg/dl ; if glucose intolerance or diabetes, HbA1C less or equal to 8,5% Normal ophthalmologic examination for all patients Effective contraception during the treatment period. No breastfeeding during the study period Signed informed consent Exclusion Criteria: Co-infection with hepatitis B (positive HBs antigen) Hemochromatosis Alpha-1 anti-trypsin deficiency Wilson disease Alcoholism-related liver disease Gilbert disease Liver cirrhosis Hepatocellular carcinoma. Alcohol intake over 50g/day for males and 40 g/day for females Intravenous drug use Psychiatric disease: history of severe nervous breakdown or severe psychiatric diseases such as major psychosis, suicidal ideas, suicide attempts… Epilepsy Auto-immune disease Heart disease in the six months preceding enrolment - patients with significant changes at EKG Uncontrolled diabetes Chronic respiratory insufficiency with hypoxemia under 10 kPa Medical or surgical condition non-stabilized, with life expectancy lower than two years Pregnancy or breastfeeding Unavailability for regular follow-up during the study
Sites / Locations
- National Hepatology and Tropical Medicine Research Institute
Arms of the Study
Arm 1
Experimental
1