Chronic Hepatitis C Treatment by Pegylated Interferon and Ribavirin in Naive Egyptian Patients (ANRS 1211)
|Chronic Hepatitis C||Drug: pegylated interferon alpha2a Drug: ribavirin||Phase 3|
|Study Design:||Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
|Official Title:||Clinical Trial of the Efficacy of the Combination of Pegylated Interferon (PEG-IFNα-2a) Plus Ribavirin in Egyptian Patients With Untreated Chronic Hepatitis C|
- - Disappearance of HCV RNA by qualitative PCR 24 weeks after the end of treatment
- Evaluation of HCV RNA at 12 and 24 weeks
- changes in HCV RNA load during treatment
- Normalization of ALT during treatment and 24 weeks after the end of treatment
- Study of side effects
- Histological changes 24 weeks after the end of treatment (decrease by at least 1 point of the Metavir score)
|Study Start Date:||August 2002|
|Study Completion Date:||January 2005|
Egypt is the country with the highest HCV prevalence worldwide, and the number of infected Egyptians is estimated around 8 million. The HCV genotype circulating in Egypt is genotype 4. This genotype has the reputation, based on the few available data, to respond poorly to treatment. This study will estimate the safety and efficacy of the combination of peg-IFNα-2a plus Ribavirin, in Egyptian patients with chronic hepatitis C. This treatment has been chosen based on its better expected efficacy compared to pegylated interferon alone.
The primary objective of the study is to assess the efficacy and tolerance of the combination of pegylated interferon (peg-IFNα-2a) plus ribavirin in Egyptian patients with chronic hepatitis C and with no prior treatment for HCV.
Methods: Open trial. Follow-up duration: 72 weeks. Enrolment duration: 18 months. Total trial duration: 3 years and a half, including trial analysis (carried out in the 6 months following the follow-up completion of the last patient). Total number of patients: 100. Precision around the expected efficacy rate (40% in intention-to-treat analysis): 9.6%.
Treatment strategy: Peg-IFNα-2a 180microg/week for 48 weeks, Ribavirin at least 11 mg/kg/day for 48 weeks Main inclusion criteria: HCV RNA positive by PCR; METAVIR score : >A2 and >= F1 or >= A1 and > F2; ALAT over 1.5*N; no prior treatment with IFNalpha, PEG-IFNalpha and ribavirin Main exclusion criteria : Liver disease other than hepatitis C; advanced liver disease; negative HCV RNA.
Patient from a cohort follow-up conducted in a village in rural Egypt with High HCV prevalence (Menoufia governorate) will be proposed to participate in the trial. Pre-enrolment investigations, liver biopsy, and patients follow-up will be carried out at a local hospital. Blood test analyses will be carried out under the responsibility of Hepatitis Virology Reference Laboratory at the National Hepatology and Tropical Medicine Institute, Cairo; trial monitoring will be carried out by the Department of Community Medicine of Ain Shams; methodological assistance from the “Unite des Maladies Emergentes” at Pasteur Institute and INSERM U444, Paris.
Treatment for patients with HCV RNA by qualitative PCR still positive after 24 weeks of the combination Peg-IFNα-2a with ribavirin, will be stopped.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00158496
|Ismail Sallam hospital|
|Zawiat Razin, Menoufia, Egypt|
|National Hepatology and Tropical Medicine Research Institute|
|Study Chair:||Arnaud Fontanet||Institut Pasteur de Paris|
|Principal Investigator:||Mostafa K Mohamed||National Hepatology and Tropical Medicine Research Institute|