Analysis of the Duration of Combination Therapy That is Necessary for HCV Genotype 1 Eradication

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

Open-label, single centre study evaluating efficacy and viral kinetics of combination PEG-IFNa2a and Ribavirin treatment on CHC genotype 1 patients, administered until viral clearance demonstrated between 4 - 12 weeks, then randomised to further continued combination treatment for one of three defined durations. Followed-up for 24 weeks after treatment cessation.

Objectives:

1. To determine the necessary duration of combination treatment with Pegylated-Interferon alfa2a (PEGASYS) & Ribavirin in Patients infected with genotype 1, in order to achieve viral clearance

2. To identify host factors, which are associated with different patterns of virological response to combination treatment (fast responder, slow responder, non-responder). On this basis, to identify possible predictors for the duration of antiviral treatment.

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

Details

• Lead Sponsor: University College London Hospitals
• Treatments: Interferon alpha-2; Interferon-alpha; Interferons; Peginterferon alfa-2a; Ribavirin

Criteria

Inclusion Criteria:

• Age 18 - 65

• HCV RNA positive

• HCV genotype 1

• Histologically proven chronic hepatitis

• No previous antiviral treatment

Exclusion Criteria:

• Liver histology showing cirrhosis

• Decompensated liver function

• WCC < 1500/mm3 or platelet count <90,000/mm3

• Co-infection with HIV or HBV/HAV

• Alcohol intake greater than 40 units/week

• Current intravenous drug dependence

• Pregnancy or breast feeding of infants

• Inadequate contraception

• Neuropsychiatric disorder

• Neoplastic disease

• Other significant medical problems