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

This study has been completed.
Sponsor:
Collaborator:
Hoffmann-La Roche
Information provided by:
French National Agency for Research on AIDS and Viral Hepatitis
ClinicalTrials.gov Identifier:
NCT00158522
First received: September 8, 2005
Last updated: February 6, 2008
Last verified: February 2008
  Purpose

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.


Condition Intervention Phase
Hepatitis C
Drug: pegylated interferon alpha2a
Phase 3

Study Type: Interventional
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

Resource links provided by NLM:


Further study details as provided by French National Agency for Research on AIDS and Viral Hepatitis:

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

Enrollment: 31
Study Start Date: February 2003
Study Completion Date: December 2007
Primary Completion Date: December 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: pegylated interferon alpha2a

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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00158522

Locations
Egypt
National Hepatology and Tropical Medicine Research Institute
Cairo, Egypt
Sponsors and Collaborators
French National Agency for Research on AIDS and Viral Hepatitis
Hoffmann-La Roche
Investigators
Principal Investigator: Mostafa K Mohamed National Hepatology and Tropical Medicine Research Institute
Study Chair: Fontanet Arnaud Institut Pasteur de Paris
  More Information

Additional Information:
Publications:
Responsible Party: Director, ANRS
ClinicalTrials.gov Identifier: NCT00158522     History of Changes
Other Study ID Numbers: ANRS 1213
Study First Received: September 8, 2005
Last Updated: February 6, 2008
Health Authority: Egypt: Ministry of Health and Population

Keywords provided by French National Agency for Research on AIDS and Viral Hepatitis:
Acute hepatitis C
Genotype 4
Pegylated Interferon
Egypt

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Hepatitis C
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Flaviviridae Infections
Interferon-alpha
Interferon Alfa-2a
Interferons
Peginterferon alfa-2a
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Immunologic Factors
Physiological Effects of Drugs
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Growth Inhibitors
Antineoplastic Agents

ClinicalTrials.gov processed this record on April 17, 2014