Chronic Hepatitis C Treatment by Pegylated Interferon and Ribavirin in Naive Egyptian Patients (ANRS 1211)

NCT00158496 | Completed Phase 3 DMC

• 1 other identifier: ANRS 1211
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 2

Brief Summary

Chronic hepatitis C is a liver disease related to a virus: hepatitis C virus (HCV). The type of HCV present in Egypt (genotype 4), has the reputation to respond poorly to Interferon treatment at the chronic stage. 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 proved to be more effective than standard Interferon. The combination of two drugs, Interferon and Ribavirin, is considered to be the best treatment available for chronic hepatitis C.

Conditions

Chronic Hepatitis C

Keywords

Chronic Hepatitis C; Genotype 4; Pegylated Interferon; Ribavirin; Egypt

Outcome Measures

Primary Outcomes (1)

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

Secondary Outcomes (5)

• Evaluation of HCV RNA at 12 and 24 weeks

• changes in HCV RNA load during treatment

• Normalization of ALT during treatment and 24 weeks after the end of treatment

• Study of side effects

• Histological changes 24 weeks after the end of treatment (decrease by at least 1 point of the Metavir score)

Interventions

pegylated interferon alpha2a DRUG

ribavirin DRUG

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• HCV antibodies using a third generation test
• HCV RNA positive by PCR
• Liver biopsy in the past 18 months with METAVIR score over A2 and over or equal to F1, or over or equal A1 and over F2
• Patients never treated with ribavirin, IFNalpha or PEG-IFNalpha
• Normal albumin
• Prothrombin time over or equal to 60 percent
• Normal bilirubin
• Alpha-foeto-protein under or equal to 3 times the normal range for the laboratory
• HBs antigen negative
• Two negative Kato test (for S.mansoni) three days apart
• Hemoglobin over or equal 11g/dl,
• Leucocytes over or equal 3000/mm3
• Neutrophils over or equal 1500/mm3
• Platelets over or equal 100 000/mm3
• Blood creatinin over or equal 150 micromol/l

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
• Alcohol intake over 50g/day for males and 40 g/day for females
• Ongoing intravenous drug use
• Aggravated liver cirrhosis (history or presence of ascitis, oesophageal varicosis, liver encephalopathy)
• Hepatocellular carcinoma
• 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

Sponsors & Collaborators

• French National Agency for Research on AIDS and Viral Hepatitis: lead
• Hoffmann-La Roche: collaborator

Study Sites (2)

Ismail Sallam hospital

Zawiat Razin, Menoufia, Egypt

Location

National Hepatology and Tropical Medicine Research Institute

Cairo, Egypt

Location

Related Publications (4)

• Marzouk D, Sass J, Bakr I, El Hosseiny M, Abdel-Hamid M, Rekacewicz C, Chaturvedi N, Mohamed MK, Fontanet A. Metabolic and cardiovascular risk profiles and hepatitis C virus infection in rural Egypt. Gut. 2007 Aug;56(8):1105-10. doi: 10.1136/gut.2006.091983. Epub 2006 Sep 6.

  PMID: 16956918 BACKGROUND

• Mohamed MK, Bakr I, El-Hoseiny M, Arafa N, Hassan A, Ismail S, Anwar M, Attala M, Rekacewicz C, Zalata K, Abdel-Hamid M, Esmat G, Fontanet A. HCV-related morbidity in a rural community of Egypt. J Med Virol. 2006 Sep;78(9):1185-9. doi: 10.1002/jmv.20679.

  PMID: 16847958 BACKGROUND

• 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: 16434426 BACKGROUND

• Arafa N, El Hoseiny M, Rekacewicz C, Bakr I, El-Kafrawy S, El Daly M, Aoun S, Marzouk D, Mohamed MK, Fontanet A. Changing pattern of hepatitis C virus spread in rural areas of Egypt. J Hepatol. 2005 Sep;43(3):418-24. doi: 10.1016/j.jhep.2005.03.021.

  PMID: 16019104 BACKGROUND

Related Links

• Sponsor web page - information in french and english

MeSH Terms

Conditions

Hepatitis C, Chronic

Interventions

peginterferon alfa-2a; Ribavirin

Condition Hierarchy (Ancestors)

Hepatitis C; Blood-Borne Infections; Communicable Diseases; Infections; Hepatitis, Viral, Human; Virus Diseases; Flaviviridae Infections; RNA Virus Infections; Hepatitis, Chronic; Hepatitis; Liver Diseases; Digestive System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Ribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides

Study Officials

• Arnaud Fontanet

  Institut Pasteur de Paris

  STUDY CHAIR

• Mostafa K Mohamed

  National Hepatology and Tropical Medicine Research Institute

  PRINCIPAL INVESTIGATOR

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: August 1, 2002
• Study Completion: January 1, 2005
• Last Updated: April 24, 2007

Record last verified: 2007-04

Locations

EG (2)