Home
Search
Study Topics
Glossary
|
|
|
|
|
Sponsors and Collaborators: |
French National Agency for Research on AIDS and Viral Hepatitis Hoffmann-La Roche |
---|---|
Information provided by: | French National Agency for Research on AIDS and Viral Hepatitis |
ClinicalTrials.gov Identifier: | NCT00158496 |
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.
Condition | Intervention | Phase |
---|---|---|
Chronic Hepatitis C |
Drug: pegylated interferon alpha2a Drug: ribavirin |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study |
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 |
Estimated Enrollment: | 100 |
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.
Ages Eligible for Study: | 18 Years to 65 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Egypt | |
National Hepatology and Tropical Medicine Research Institute | |
Cairo, Egypt | |
Egypt, Menoufia | |
Ismail Sallam hospital | |
Zawiat Razin, Menoufia, Egypt |
Study Chair: | Arnaud Fontanet | Institut Pasteur de Paris |
Principal Investigator: | Mostafa K Mohamed | National Hepatology and Tropical Medicine Research Institute |
Study ID Numbers: | ANRS 1211 |
Study First Received: | September 8, 2005 |
Last Updated: | April 23, 2007 |
ClinicalTrials.gov Identifier: | NCT00158496 History of Changes |
Health Authority: | Egypt: Ministry of Health and Population |
Chronic Hepatitis C Genotype 4 Pegylated Interferon Ribavirin Egypt |
Antimetabolites Interferon-alpha Liver Diseases Immunologic Factors Hepatitis, Chronic Ribavirin Interferons Hepatitis, Viral, Human Angiogenesis Inhibitors |
Antiviral Agents Hepatitis Virus Diseases Digestive System Diseases Peginterferon alfa-2a Hepatitis C Interferon Alfa-2a Hepatitis C, Chronic |
Antimetabolites Anti-Infective Agents Liver Diseases Molecular Mechanisms of Pharmacological Action Flaviviridae Infections Hepatitis, Chronic Immunologic Factors Antineoplastic Agents Ribavirin Physiological Effects of Drugs Hepatitis, Viral, Human Therapeutic Uses Hepatitis C Angiogenesis Modulating Agents |
Growth Inhibitors Interferon-alpha RNA Virus Infections Growth Substances Interferons Antiviral Agents Angiogenesis Inhibitors Pharmacologic Actions Virus Diseases Hepatitis Digestive System Diseases Peginterferon alfa-2a Interferon Alfa-2a Hepatitis C, Chronic |