Ignite Creation Date:
2024-05-05 @ 12:03 PM
Last Modification Date:
2024-10-26 @ 9:19 AM
Study NCT ID:
NCT00221624
Status:
COMPLETED
Last Update Posted:
2007-06-13
First Post:
2005-09-13
Brief Title:
Peginterferon Alfa-2a Plus Ribavirin Plus Amantadine for the Treatment of Hepatitis C Infected Patients
Sponsor:
University Hospital Bordeaux
Organization:
University Hospital Bordeaux
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2007-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PEGARI
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
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 weeksdetectable HCV RNA
primary outcome sustained virological response defined as an undetectable HCV RNA level 24 weeks after the end of anti HCV treatment
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 weeksdetectable HCV RNA
primary outcome sustained virological response defined as an undetectable HCV RNA level 24 weeks after the end of anti HCV treatment
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2000-030 | None | None | None |