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Clinical Trial Name - Peginterferon Alfa-2a Plus Ribavirin Plus Amantadine for the Treatment of Hepatitis C Infected Pat
| Original Study ID : 7929-01 |
| Secondary ID : 2000-030 |
| NCT ID : NCT00221624 |
| 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. |
| Source : University Hospital, Bordeaux |
| 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. |
| Overall Status : Completed |
| Start Date : November 2001 |
| End Date : April 2004 |
| Completion Date : April 2004 |
| Official Title : Phase 3 |
| Phase : Interventional |
| Study Design : Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Safety/Efficacy Study |
| Enrollment : 131 |
| Verification Date : June 2007 |
| First Received Date : September 13, 2005 |
| Trial Eligibility |
| Criteria : Inclusion Criteria: - Chronic hepatitis C - Previously treated with a combination of interferon plus ribavirin for at least 24 weeks - Detectable HCV RNA (i.e. non responders) - Signed informed consent Exclusion Criteria: - Evidence of another cause of liver disease - Liver cirrhosis (child-Pugh stage BMC) - Alcohol consumption > 30g/day for women or > 40g/day for men ; drug abuse - Other serious relevant disorders : psychiatric condition (especially depression), cardio-vascular disease, renal decompensation, seizure history, hemoglobinopathy, auto-immune disease |
| Gender : Both |
| Minimum Age : 18 Years |
| Maximum Age : 70 Years |
| Healthy Volunteers : No |
| Facilities |
| Facility Name : Service d’hépato-Gastro-Entérologie - Hôpital Haut Leveque - avenue de Magellan |
| City : Pessac |
| Zip Code : 33604 |
| Country : France |
| OutComes |
| Primary OutComes |
| Measure : 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 |
| Secondary OutComes |
| Measure : ALT < upper limit of normal values, |
| Time Frame : 24 weeks after the end of anti-HCV treatment |
| Measure : histological response according to METAVIR score |
| Time Frame : 24 weeks after the end of anti-HCV treatment |
| Measure : adverse effects |
| Time Frame : 24 weeks after the end of anti-HCV treatment |
| Measure : quality of life assessed |
| Time Frame : at week 72 |
| Interventions |
| Type : Drug |
| Name : Peginterferon alfa-2a |
| Type : Drug |
| Name : ribavirin |
| Type : Drug |
| Name : amantadine |
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