A Phase 4 interventional study of Pegylated interferon-alfa2a (Pegasys); ribavirin in Chronic Hepatitis C, HCV Genotype 1, sponsored by University College London Hospitals. Completed at 1 site in United Kingdom. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2005-12-01.
Sponsored by University College London Hospitals · Phase 4, Interventional, and Treatment
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:
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will be discontinued for patients who remain persistently HCV RNA positive at treatment week 12 and they will be withdrawn from the study protocol.
2,321 studies on the registry are indexed under Hepatitis C; 102 are open to participants now.
This study's enrollment of 40 is below the median of 79 across 1,633 interventional studies indexed under Hepatitis C.
Browse Hepatitis C studies →University College London Hospitals is the lead sponsor of 61 studies on the registry; 9 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Sustained virological response (HCV RNA negative) 6 months post-treatment cessation
Hepatic and serum HCV RNA levels as a predictor for treatment duration
HCV-specific T-cell reactivity as a predictor for treatment duration
This study is completed, as verified in Sep 2005. You cannot join it, but the record below documents what was studied.
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University College London Hospitals