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| Tracking Information | |||||
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| 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 |
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| 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:
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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will be discontinued for patients who remain persistently HCV RNA positive at treatment week 12 and they will be withdrawn from the study protocol.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 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 * | |||||
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Enrollment ICMJE | 40 | ||||
| Completion Date | |||||
| Primary Completion Date | |||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 18 Years to 65 Years | ||||
| Accepts Healthy Volunteers | No | ||||
| 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 |
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| Information Provided By | University College London Hospitals | ||||
| Verification Date | September 2005 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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