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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:
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| 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will be discontinued for patients who remain persistently HCV RNA positive at treatment week 12 and they will be withdrawn from the study protocol. |
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| 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 |
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| Condition † | Chronic Hepatitis C, HCV Genotype 1 | ||||
| Intervention † | Drug: Pegylated interferon-alfa2a (Pegasys); ribavirin | ||||
| MEDLINE PMIDs | |||||
| Links | |||||
| Recruitment Information Fields | |||||
| Recruitment Status † | Completed | ||||
| Enrollment † | 40 | ||||
| Start Date † | April 2002 | ||||
| Completion Date | |||||
| Eligibility Criteria † | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 18 Years to 65 Years | ||||
| Accepts Healthy Volunteers | No | ||||
| 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 † |
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| Information Provided By | University College London Hospitals | ||||
| Verification Date | September 2005 | ||||
| First Received Date † | September 7, 2005 | ||||
| Last Updated Date | November 29, 2005 | ||||