Efficacy of Pegylated Interferon Alone in Egyptian Patients With Acute Hepatitis C (ANRS 1213)
|ClinicalTrials.gov Identifier: NCT00158522|
Recruitment Status : Completed
First Posted : September 12, 2005
Last Update Posted : February 8, 2008
|Condition or disease||Intervention/treatment||Phase|
|Hepatitis C||Drug: pegylated interferon alpha2a||Phase 3|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||31 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Clinical Trial of the Efficacy of Pegylated Interferon (PEG-IFNα-2a) Alone in Egyptian Patients With Acute Hepatitis C|
|Study Start Date :||February 2003|
|Actual Primary Completion Date :||December 2007|
|Actual Study Completion Date :||December 2007|
|Experimental: 1||Drug: pegylated interferon alpha2a|
- 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
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|