Short Course of Interferon Treatment in Patients With HCV Infection

• Status: Completed
• Trial end date: 2007-11-01
• Target enrollment: 0
• Participant gender: All

Summary

To determine if a shorter course of interferon and ribavirin therapy will be sufficient in carefully selected patients with chronic hepatitis C virus genotype 3 infection, as compared to the standard length of treatment of 6 months.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Aga Khan University
• Collaborator: Getz Pharma
• Treatments: Interferons; Iron-Dextran Complex; Ribavirin

Criteria

Inclusion Criteria:

• Adult males and non-pregnant females (more than 18 and less than equal to 50 years of age).

• Treatment naïve patients.

• Serological evidence of hepatitis C infection by an anti-HCV antibody test

• HCV PCR positive

• Genotype 3

• Absence of cirrhosis on liver biopsy.

• Absence of alcohol or drug abuse.

Exclusion Criteria:

• Patients who do not consent to be included in the study.

• Pregnant or breast feeding females.

• Patients with a hemoglobin of <10g/dl, ANC <1500c/mm, and a platelet count <90000c/mm.

• Genotype non 3

• HCV PCR positive at the end of 4 weeks of treatment.

• Presence of cirrhosis on liver biopsy.

• Decompensated liver disease.

• History or other evidence of a medical condition associated with chronic liver disease other than CHC (e.g., hemochromatosis, autoimmune hepatitis, metabolic liver disease, alcoholic liver disease, toxin exposure)

• History of having received IFN, PEG-IFN, RBV therapy previously.

• History of systemic antiviral therapy or investigational drug 3 months prior to the first dose of study treatment.

• Patients expected to need systemic antiviral therapy at any time during their participation in the study.

• Exceptions from the last two exclusion criteria are patients who have had a limited (less than 7 day) course of acyclovir or valacyclovir for herpetic lesions more than 1 month prior to the first administration of trial treatment.