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

Chronic Hepatitis C, HCV Genotype 1 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00152581
• Other study ID #: 01/0277
• Status: Completed
• Phase: Phase 4
• First received: September 7, 2005
• Last updated: November 29, 2005
• Start date: April 2002

Study information

• Verified date: September 2005
• Source: University College London Hospitals
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency
• Study type: Interventional

Clinical Trial 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.

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will be discontinued for patients who remain persistently HCV RNA positive at treatment week 12 and they will be withdrawn from the study protocol.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Hepatitis C, HCV Genotype 1
• Hepatitis C, Chronic
• Hepatitis, Chronic

Intervention

Drug:
• Pegylated interferon-alfa2a (Pegasys); ribavirin

Locations

Country	Name	City	State
United Kingdom	Hepatitis Clinic	University College London Hospital	London

Sponsors (1)

Lead Sponsor	Collaborator
University College London Hospitals

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Sustained virological response (HCV RNA negative) 6 months post-treatment cessation
Secondary	Hepatic and serum HCV RNA levels as a predictor for treatment duration
Secondary	HCV-specific T-cell reactivity as a predictor for treatment duration