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

NCT00152581 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2005-12-01

No results posted yet for this study

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.

Conditions

  • Chronic Hepatitis C, HCV Genotype 1

Interventions

DRUG

Pegylated interferon-alfa2a (Pegasys); ribavirin

Sponsors & Collaborators

  • University College London Hospitals

    lead OTHER

Principal Investigators

  • Nikolai V. Naoumov, MD · Institute of Hepatology, University College London

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2002-04-30

Countries

  • United Kingdom

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00152581 on ClinicalTrials.gov