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

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

This study has been completed.

Study NCT00152581. Last updated on November 29, 2005. Information provided by University College London Hospitals

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Descriptive Information Fields

Brief Title ^†

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

Official Title ^†

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

Brief 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:

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
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.

Detailed Description

Forty treatment-naïve patients with chronic hepatitis C, all infected with genotype 1, will be entered into this study. All 40 patients will be started on the same regimen of 180mg Pegylated-Interferon alfa2a (PEGASYS) weekly plus Ribavirin 1000-1200mg daily. HCV RNA in the serum will be monitored by qualitative PCR at treatment weeks 4, 8 and 12. Patients who become HCV RNA negative at any of the above time-points (4,8 or 12), will be randomised into one of three groups to continue the same antiviral regimen for an additional 3 month, 6 month or 9 month period. All these patients will subsequently be followed-up and monitored for a further 6 months after stopping all antiviral treatment.

Treatment will be discontinued for patients who remain persistently HCV RNA positive at treatment week 12 and they will be withdrawn from the study protocol.

Study Phase

Phase IV

Study Type ^†

Interventional

Study Design ^†

Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study

Primary Outcome Measure ^†

Sustained virological response (HCV RNA negative) 6 months post-treatment cessation

Secondary Outcome Measure ^†

Hepatic and serum HCV RNA levels as a predictor for treatment duration
HCV-specific T-cell reactivity as a predictor for treatment duration

Condition ^†

Chronic Hepatitis C, HCV Genotype 1

Intervention ^†

Drug: Pegylated interferon-alfa2a (Pegasys); ribavirin

MEDLINE PMIDs

Links

Recruitment Information Fields

Recruitment Status ^†

Completed

Enrollment ^†

Start Date ^†

April 2002

Completion Date

Eligibility 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

Gender

Both

Ages

18 Years to 65 Years

Accepts Healthy Volunteers

Contacts ^††

Location Countries ^†

United Kingdom

Administrative Information Fields

NCT ID ^†

NCT00152581

Organization ID

01/0277

Secondary IDs ^††

Study Sponsor ^†

University College London Hospitals

Collaborators ^††

Investigators ^†

Principal Investigator:

Nikolai V. Naoumov, MD

Institute of Hepatology, University College London

Information Provided By

University College London Hospitals

Verification Date

September 2005

First Received Date ^†

September 7, 2005

Last Updated Date

November 29, 2005

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.