Efficacy of Pegylated Interferon Alone in Egyptian Patients With Acute Hepatitis C (ANRS 1213)
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 chronic hepatitis stage. Without treatment, 85% of patients with acute hepatitis C become chronically HCV infected which means that the virus stays present in the body. 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 also proved to be more effective than standard Interferon in treatment of chronic hepatitis C.
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Clinical Trial of the Efficacy of Pegylated Interferon (PEG-IFNα-2a) Alone in Egyptian Patients With Acute Hepatitis C|
- Disappearance of HCV RNA by qualitative PCR 24 weeks after the end of treatment
- Changes in HCV RNA load
- Normalization of ALT during treatment and 24 weeks after the end of treatment
- Study of side effects
|Study Start Date:||February 2003|
|Study Completion Date:||December 2007|
|Primary Completion Date:||December 2007 (Final data collection date for primary outcome measure)|
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 in Cairo diagnoses between 5 and 10 acute hepatitis C per month. The HCV genotype circulating in Egypt is genotype 4. This genotype has the reputation to respond poorly to treatment at the chronic hepatitis stage. It would therefore be interesting to assess the treatment efficacy at the acute stage. This study will evaluate the efficacy of pegylated interferon (peg-IFNα-2a) alone in Egyptian patients with acute hepatitis C.
The study primary objective is to evaluate the efficacy and tolerance of pegylated interferon (peg-IFNα-2a) alone in Egyptian patients with acute hepatitis C.
Methods: One arm clinical trial. Follow-up duration: 36 to 48 weeks depending on response to treatment.
Main inclusion criteria: ALT> 3*N; HCV RNA positive by PCR and negative HCV serology at first presentation or positive HCV serology with a clear and unique exposure within 2 months prior the acute hepatitis episode; no prior treatment with IFNα, peg-IFNα and ribavirin; signed informed consent.
Main exclusion criteria : Liver disease other than hepatitis C. Treatment strategy: Peg-IFNα-2a 180microg/week (subcutaneous injection) for 12 weeks. Patients with positive HCV RNA by qualitative PCR at the end of the 12 weeks treatment period will be offered to continue on the same regimen up to 24 weeks.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00158522
|National Hepatology and Tropical Medicine Research Institute|
|Principal Investigator:||Mostafa K Mohamed||National Hepatology and Tropical Medicine Research Institute|
|Study Chair:||Fontanet Arnaud||Institut Pasteur de Paris|