- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00158522
Efficacy of Pegylated Interferon Alone in Egyptian Patients With Acute Hepatitis C (ANRS 1213)
Clinical Trial of the Efficacy of Pegylated Interferon (PEG-IFNα-2a) Alone in Egyptian Patients With Acute Hepatitis C
Study Overview
Detailed Description
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
Enrollment (Actual)
Phase
- Phase 3
Contacts and Locations
Study Locations
-
-
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Cairo, Egypt
- National Hepatology and Tropical Medicine Research Institute
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Acute hepatitis C:(1)ALT over 3x normal values ; IgM anti-HAV, IgM anti-HBc negative antibody ; negative HCV antibodies (3rd generation ELISA) and positive HCV PCR at first presentation, or, (2)ALT over 4x normal values ; IgM anti-HAV, IgM anti-HBc, CMV, EBV and toxoplasmoses negative antibody and negative HEV PCR ; Positive HCV antibodies (3rd generation ELISA) and positive HCV PCR at first presentation ; a clear history of exposure within 2 months prior the time of diagnosis ; no exposure to hepatotoxic drug or pesticide within 2 weeks prior the time of diagnosis
- Patients without chronic liver disease
- HBsAg negative
- Hemoglobin over or equal to 11g/dl
- Leucocytes over or equal to 3000/mm3
- Polynuclear neutrophils over or equal to 1500/mm3
- Platelets over or equal to 100 000/mm3
- Blood creatinin less or equal to 150 micromol/l
- Blood uric acid within the normal limits of the investigating center
- Normal TSH
- Antinuclear antibodies < 1/160
- Fasting blood sugar 70-115 mg/dl ; if glucose intolerance or diabetes, HbA1C less or equal to 8,5%
- Normal ophthalmologic examination for all patients
- Effective contraception during the treatment period.
- No breastfeeding during the study period
- Signed informed consent
Exclusion Criteria:
- Co-infection with hepatitis B (positive HBs antigen)
- Hemochromatosis
- Alpha-1 anti-trypsin deficiency
- Wilson disease
- Alcoholism-related liver disease
- Gilbert disease
- Liver cirrhosis
- Hepatocellular carcinoma.
- Alcohol intake over 50g/day for males and 40 g/day for females
- Intravenous drug use
- Psychiatric disease: history of severe nervous breakdown or severe psychiatric diseases such as major psychosis, suicidal ideas, suicide attempts…
- Epilepsy
- Auto-immune disease
- Heart disease in the six months preceding enrolment - patients with significant changes at EKG
- Uncontrolled diabetes
- Chronic respiratory insufficiency with hypoxemia under 10 kPa
- Medical or surgical condition non-stabilized, with life expectancy lower than two years
- Pregnancy or breastfeeding
- Unavailability for regular follow-up during the study
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: 1
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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Disappearance of HCV RNA by qualitative PCR 24 weeks after the end of treatment
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Secondary Outcome Measures
Outcome Measure |
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Normalization of ALT during treatment and 24 weeks after the end of treatment
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Study of side effects
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Changes in HCV RNA load
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Collaborators and Investigators
Collaborators
Investigators
- Study Chair: Fontanet Arnaud, Institut Pasteur de Paris
Publications and helpful links
General Publications
- Bakr I, Rekacewicz C, El Hosseiny M, Ismail S, El Daly M, El-Kafrawy S, Esmat G, Hamid MA, Mohamed MK, Fontanet A. Higher clearance of hepatitis C virus infection in females compared with males. Gut. 2006 Aug;55(8):1183-7. doi: 10.1136/gut.2005.078147. Epub 2006 Jan 24.
- El Gaafary MM, Rekacewicz C, Abdel-Rahman AG, Allam MF, El Hosseiny M, Hamid MA, Colombani F, Sultan Y, El-Aidy S, Fontanet A, Mohamed MK. Surveillance of acute hepatitis C in Cairo, Egypt. J Med Virol. 2005 Aug;76(4):520-5. doi: 10.1002/jmv.20392.
Helpful Links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Digestive System Diseases
- RNA Virus Infections
- Virus Diseases
- Infections
- Blood-Borne Infections
- Communicable Diseases
- Liver Diseases
- Flaviviridae Infections
- Hepatitis, Viral, Human
- Enterovirus Infections
- Picornaviridae Infections
- Hepatitis
- Hepatitis A
- Hepatitis C
- Physiological Effects of Drugs
- Anti-Infective Agents
- Antiviral Agents
- Antineoplastic Agents
- Immunologic Factors
- Interferons
- Interferon-alpha
- Peginterferon alfa-2a
- Interferon alpha-2
Other Study ID Numbers
- ANRS 1213
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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