Chronic Hepatitis C Treatment by Pegylated Interferon and Ribavirin in Naive Egyptian Patients (ANRS 1211)
|First Received Date ICMJE||September 8, 2005|
|Last Updated Date||April 23, 2007|
|Start Date ICMJE||August 2002|
|Primary Completion Date||Not Provided|
|Current Primary Outcome Measures ICMJE
||- Disappearance of HCV RNA by qualitative PCR 24 weeks after the end of treatment|
|Original Primary Outcome Measures ICMJE||Same as current|
|Change History||Complete list of historical versions of study NCT00158496 on ClinicalTrials.gov Archive Site|
|Current Secondary Outcome Measures ICMJE
|Original Secondary Outcome Measures ICMJE
|Current Other Outcome Measures ICMJE||Not Provided|
|Original Other Outcome Measures ICMJE||Not Provided|
|Brief Title ICMJE||Chronic Hepatitis C Treatment by Pegylated Interferon and Ribavirin in Naive Egyptian Patients (ANRS 1211)|
|Official Title ICMJE||Clinical Trial of the Efficacy of the Combination of Pegylated Interferon (PEG-IFNα-2a) Plus Ribavirin in Egyptian Patients With Untreated Chronic Hepatitis C|
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.
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.
|Study Type ICMJE||Interventional|
|Study Phase||Phase 3|
|Study Design ICMJE||Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Condition ICMJE||Chronic Hepatitis C|
|Study Arm (s)||Not Provided|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
|Recruitment Status ICMJE||Completed|
|Completion Date||January 2005|
|Primary Completion Date||Not Provided|
|Eligibility Criteria ICMJE||
|Ages||18 Years to 65 Years|
|Accepts Healthy Volunteers||No|
|Contacts ICMJE||Contact information is only displayed when the study is recruiting subjects|
|Location Countries ICMJE||Egypt|
|NCT Number ICMJE||NCT00158496|
|Other Study ID Numbers ICMJE||ANRS 1211|
|Has Data Monitoring Committee||Yes|
|Responsible Party||Not Provided|
|Study Sponsor ICMJE||French National Agency for Research on AIDS and Viral Hepatitis|
|Collaborators ICMJE||Hoffmann-La Roche|
|Information Provided By||French National Agency for Research on AIDS and Viral Hepatitis|
|Verification Date||April 2007|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP