search
Back to results

Efficacy of Pegylated Interferon Alone in Egyptian Patients With Acute Hepatitis C (ANRS 1213)

Primary Purpose

Hepatitis C

Status
Completed
Phase
Phase 3
Locations
Egypt
Study Type
Interventional
Intervention
pegylated interferon alpha2a
Sponsored by
French National Agency for Research on AIDS and Viral Hepatitis
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hepatitis C focused on measuring Acute hepatitis C, Genotype 4, Pegylated Interferon, Egypt

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • National Hepatology and Tropical Medicine Research Institute

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

1

Arm Description

Outcomes

Primary Outcome Measures

Disappearance of HCV RNA by qualitative PCR 24 weeks after the end of treatment

Secondary Outcome Measures

Changes in HCV RNA load
Normalization of ALT during treatment and 24 weeks after the end of treatment
Study of side effects

Full Information

First Posted
September 8, 2005
Last Updated
February 6, 2008
Sponsor
French National Agency for Research on AIDS and Viral Hepatitis
Collaborators
Hoffmann-La Roche
search

1. Study Identification

Unique Protocol Identification Number
NCT00158522
Brief Title
Efficacy of Pegylated Interferon Alone in Egyptian Patients With Acute Hepatitis C (ANRS 1213)
Official Title
Clinical Trial of the Efficacy of Pegylated Interferon (PEG-IFNα-2a) Alone in Egyptian Patients With Acute Hepatitis C
Study Type
Interventional

2. Study Status

Record Verification Date
February 2008
Overall Recruitment Status
Completed
Study Start Date
February 2003 (undefined)
Primary Completion Date
December 2007 (Actual)
Study Completion Date
December 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
French National Agency for Research on AIDS and Viral Hepatitis
Collaborators
Hoffmann-La Roche

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatitis C
Keywords
Acute hepatitis C, Genotype 4, Pegylated Interferon, Egypt

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
31 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
pegylated interferon alpha2a
Primary Outcome Measure Information:
Title
Disappearance of HCV RNA by qualitative PCR 24 weeks after the end of treatment
Secondary Outcome Measure Information:
Title
Changes in HCV RNA load
Title
Normalization of ALT during treatment and 24 weeks after the end of treatment
Title
Study of side effects

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mostafa K Mohamed
Organizational Affiliation
National Hepatology and Tropical Medicine Research Institute
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Fontanet Arnaud
Organizational Affiliation
Institut Pasteur de Paris
Official's Role
Study Chair
Facility Information:
Facility Name
National Hepatology and Tropical Medicine Research Institute
City
Cairo
Country
Egypt

12. IPD Sharing Statement

Citations:
PubMed Identifier
16434426
Citation
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.
Results Reference
background
PubMed Identifier
15977225
Citation
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.
Results Reference
background
Links:
URL
http://www.anrs.fr
Description
Sponsor web page - information in french and english

Learn more about this trial

Efficacy of Pegylated Interferon Alone in Egyptian Patients With Acute Hepatitis C (ANRS 1213)

We'll reach out to this number within 24 hrs