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
1 other identifier
interventional
31
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3
Started Feb 2003
Longer than P75 for phase_3
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2003
CompletedFirst Submitted
Initial submission to the registry
September 8, 2005
CompletedFirst Posted
Study publicly available on registry
September 12, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2007
CompletedFebruary 8, 2008
February 1, 2008
4.8 years
September 8, 2005
February 6, 2008
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Disappearance of HCV RNA by qualitative PCR 24 weeks after the end of treatment
Secondary Outcomes (3)
Changes in HCV RNA load
Normalization of ALT during treatment and 24 weeks after the end of treatment
Study of side effects
Study Arms (1)
1
EXPERIMENTALInterventions
Eligibility Criteria
You may qualify if:
- 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
- +1 more criteria
You may not qualify if:
- 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
- +4 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
National Hepatology and Tropical Medicine Research Institute
Cairo, Egypt
Related Publications (2)
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.
PMID: 16434426BACKGROUNDEl 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.
PMID: 15977225BACKGROUND
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Mostafa K Mohamed
National Hepatology and Tropical Medicine Research Institute
- STUDY CHAIR
Fontanet Arnaud
Institut Pasteur de Paris
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER GOV
Study Record Dates
First Submitted
September 8, 2005
First Posted
September 12, 2005
Study Start
February 1, 2003
Primary Completion
December 1, 2007
Study Completion
December 1, 2007
Last Updated
February 8, 2008
Record last verified: 2008-02