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

Tracking Information

First Received Date ^ICMJE

September 7, 2005

Last Updated Date

November 29, 2005

Start Date ^ICMJE

April 2002

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

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

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00152581 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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

Original Secondary Outcome Measures ^ICMJE

Same as current

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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 ^ICMJE

Interventional

Study Design ^ICMJE

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

Condition ^ICMJE

Chronic Hepatitis C, HCV Genotype 1

Intervention ^ICMJE

Drug: Pegylated interferon-alfa2a (Pegasys); ribavirin

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

Primary Completion Date

Eligibility Criteria ^ICMJE

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 ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United Kingdom

Administrative Information

NCT ID ^ICMJE

NCT00152581

Responsible Party

Study ID Numbers ^ICMJE

01/0277

Study Sponsor ^ICMJE

University College London Hospitals

Collaborators ^ICMJE

Investigators ^ICMJE

Principal Investigator:

Nikolai V. Naoumov, MD

Institute of Hepatology, University College London

Information Provided By

University College London Hospitals

Verification Date

September 2005

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP