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| Tracking Information | |||||||||
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| First Received Date † | September 13, 2005 | ||||||||
| Last Updated Date | June 12, 2007 | ||||||||
| Start Date † | November 2001 | ||||||||
| Current Primary Outcome Measures † |
sustained virological response, defined as an undetectable HCV RNA level 24 weeks after the end of anti HCV treatment (i.e. overall 72 weeks after randomization) [ Time Frame: 24 weeks after the end of antiHCV treatment ] | ||||||||
| Original Primary Outcome Measures † | Same as current | ||||||||
| Change History | Complete list of historical versions of study NCT00221624 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures † |
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| Original Secondary Outcome Measures † |
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| Descriptive Information | |||||||||
| Brief Title † | Peginterferon Alfa-2a Plus Ribavirin Plus Amantadine for the Treatment of Hepatitis C Infected Patients | ||||||||
| Official Title † | Randomized Placebo-Controlled Trial of a Triple Therapy Combining Peginterferon Alfa-2a Plus Ribavirin Plus Amantadine Versus Peginterferon Alfa-2a Plus Ribavirin Plus Placebo in Hepatitis C-Infected Patients Non Responders to a First-Line Therapy of Interferon and Ribavirin | ||||||||
| Brief Summary | Response to a second-line anti-HCV treatment in non responder patients to a first-line dual therapy remains very poor. Preliminary studies of amantadine suggest that this drug could be potentially effective to treat hepatitis C. |
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| Detailed Description | Background : Response to a second-line anti-HCV treatment in non responder patients to a first-line dual therapy remains very poor. Preliminary studies of amantadine suggest that this drug could be potentially effective to treat hepatitis C. Design : randomized, double-blind, multicenter trial. Interventions compared : Peg-interferon alfa 2A + ribavirin + amantadine versus Peg-interferon alfa 2A + ribavirin + Placebo Eligibility criteria : Chronic hepatitis C, previously treated with combination of interferon plus ribavirin for at least 24 weeks,detectable HCV RNA. primary outcome : sustained virological response, defined as an undetectable HCV RNA level 24 weeks after the end of anti HCV treatment. |
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| Study Phase | Phase III | ||||||||
| Study Type † | Interventional | ||||||||
| Study Design † | Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Safety/Efficacy Study | ||||||||
| Condition † |
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| Intervention † |
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| 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 † | Completed | ||||||||
| Enrollment † | 131 | ||||||||
| Completion Date | April 2004 | ||||||||
| Primary Completion Date | |||||||||
| Eligibility Criteria † | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||||||
| Ages | 18 Years to 70 Years | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts †† | |||||||||
| Location Countries † | France | ||||||||
| Expanded Access Status | |||||||||
| Administrative Information | |||||||||
| NCT ID † | NCT00221624 | ||||||||
| Responsible Party | |||||||||
| Secondary IDs †† | 2000-030 | ||||||||
| Study Sponsor † | University Hospital, Bordeaux | ||||||||
| Collaborators †† | Hoffmann-La Roche | ||||||||
| Investigators † |
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| Information Provided By | University Hospital, Bordeaux | ||||||||
| Verification Date | June 2007 | ||||||||
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† Required WHO trial registration data element. †† WHO trial registration data element that is required only if it exists. |
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