Status:
COMPLETED
Efficacy of Pegylated Interferon Alone in Egyptian Patients With Acute Hepatitis C (ANRS 1213)
Lead Sponsor:
French National Agency for Research on AIDS and Viral Hepatitis
Collaborating Sponsors:
Hoffmann-La Roche
Conditions:
Hepatitis C
Eligibility:
All Genders
18-65 years
Phase:
PHASE3
Brief Summary
Acute hepatitis C is a liver disease related to a virus: hepatitis C virus (HCV). The type of Hepatitis C Virus present in Egypt (genotype 4), has the reputation to respond poorly to treatment at the ...
Detailed Description
Egypt is the country with the highest HCV prevalence worldwide, and the number of infected Egyptians is estimated around 8 million. HCV incidence is high as well, and a typical hepatology department i...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
February 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2007
Estimated Enrollment :
31 Patients enrolled
Trial Details
Trial ID
NCT00158522
Start Date
February 1 2003
End Date
December 1 2007
Last Update
February 8 2008
Active Locations (1)
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1
National Hepatology and Tropical Medicine Research Institute
Cairo, Egypt