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

Primary Purpose

Chronic Hepatitis C, HCV Genotype 1

Status

Completed

Phase

Phase 4

Locations

United Kingdom

Study Type

Interventional

Intervention

Pegylated interferon-alfa2a (Pegasys); ribavirin

About this trial

This is an interventional treatment trial for Chronic Hepatitis C, HCV Genotype 1 focused on measuring HCV, genotype 1, treatment, HCV kinetics, T-cells

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Hepatitis Clinic

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Hepatic and serum HCV RNA levels as a predictor for treatment duration

HCV-specific T-cell reactivity as a predictor for treatment duration

Full Information

NCT ID

NCT00152581

First Posted

September 7, 2005

Last Updated

November 29, 2005

Sponsor

University College London Hospitals

1. Study Identification

Unique Protocol Identification Number

NCT00152581

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

Study Type

Interventional

2. Study Status

Record Verification Date

September 2005

Overall Recruitment Status

Completed

Study Start Date

April 2002 (undefined)

Primary Completion Date

undefined (undefined)

Study Completion Date

undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor

University College London Hospitals

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Chronic Hepatitis C, HCV Genotype 1

Keywords

HCV, genotype 1, treatment, HCV kinetics, T-cells

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

40 (false)

8. Arms, Groups, and Interventions

Intervention Type

Drug

Intervention Name(s)

Pegylated interferon-alfa2a (Pegasys); ribavirin

Primary Outcome Measure Information:

Title

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

Secondary Outcome Measure Information:

Title

Hepatic and serum HCV RNA levels as a predictor for treatment duration

Title

HCV-specific T-cell reactivity as a predictor for treatment duration

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Nikolai V. Naoumov, MD

Organizational Affiliation

Institute of Hepatology, University College London

Official's Role

Principal Investigator

Facility Information:

Facility Name

Hepatitis Clinic

City

University College London Hospital

State/Province

London

ZIP/Postal Code

WC1E 6HX

Country

United Kingdom

12. IPD Sharing Statement

Learn more about this trial

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

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