Chronic Hepatitis C Treatment by Pegylated Interferon and Ribavirin in Naive Egyptian Patients (ANRS 1211)

• Status: Completed
• Trial end date: 2005-01-01
• Target enrollment: 0
• Participant gender: All

Summary

Chronic hepatitis C is a liver disease related to a virus: hepatitis C virus (HCV). The type of HCV present in Egypt (genotype 4), has the reputation to respond poorly to Interferon treatment at the chronic stage. Pegylated Interferon is a new form of Interferon that stays in the body for longer time and allows the patient to take less injection per week. It has proved to be more effective than standard Interferon. The combination of two drugs, Interferon and Ribavirin, is considered to be the best treatment available for chronic hepatitis C.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: French National Agency for Research on AIDS and Viral Hepatitis
• Collaborator: Hoffmann-La Roche
• Treatments: Interferon alpha-2; Interferon-alpha; Interferons; Peginterferon alfa-2a; Ribavirin

Criteria

Inclusion Criteria:

• HCV antibodies using a third generation test

• HCV RNA positive by PCR

• Liver biopsy in the past 18 months with METAVIR score over A2 and over or equal to F1, or over or equal A1 and over F2

• ALT over 1.5 time the normal range in the 24 weeks prior to inclusion (Week-28; W-2);

• Patients never treated with ribavirin, IFNalpha or PEG-IFNalpha

• Normal albumin

• Prothrombin time over or equal to 60 percent

• Normal bilirubin

• Alpha-foeto-protein under or equal to 3 times the normal range for the laboratory

• HBs antigen negative

• Two negative Kato test (for S.mansoni) three days apart

• Hemoglobin over or equal 11g/dl,

• Leucocytes over or equal 3000/mm3

• Neutrophils over or equal 1500/mm3

• Platelets over or equal 100 000/mm3

• Blood creatinin over or equal 150 micromol/l

• Normal TSH

• Anti-nuclear antibodies under 1/160

• Fasting blood sugar between 70-115mg/dl (if glucose intolerance or diabetes: HbA1C <= 8,5%)

• Normal ophthalmologic examination in patients with history of blood pressure and/or diabetes

• 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

• Alcohol intake over 50g/day for males and 40 g/day for females

• Ongoing intravenous drug use

• Aggravated liver cirrhosis (history or presence of ascitis, oesophageal varicosis, liver encephalopathy)

• Hepatocellular carcinoma

• 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 <10 kPa

• Medical or surgical condition, non-stabilised, with life expectancy lower than two years.

• Pregnancy or breastfeeding