Ignite Creation Date:
2024-05-05 @ 11:45 AM
Last Modification Date:
2024-10-26 @ 9:13 AM
Study NCT ID:
NCT00127777
Status:
UNKNOWN
Last Update Posted:
2005-08-25
First Post:
2005-08-04
Brief Title:
Peginterferon Alfa-2a Ribavirin AmantadinePlacebo in Hepatitis C Virus HCV-Genotype-1-Infection PRAMA
Sponsor:
University Hospital Saarland
Organization:
University Hospital Saarland
Study Overview
Official Title:
Randomized Multi-Center Partially Placebo-Controlled Phase IV-Study to Compare Efficacy and Tolerability of 48-Week Combined Therapy With Peginterferon Alfa-2a Ribavirin and Amantadine Sulphate Versus Placebo in Untreated Patients With Chronic Hepatitis C Virus-Genotype-1-Infection
Status:
UNKNOWN
Status Verified Date:
2005-08
Last Known Status:
ACTIVE_NOT_RECRUITING
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:
None
Brief Summary:
This was a randomized multi-center partially placebo-controlled Phase IV study to compare the efficacy and tolerability of a 48-week combined therapy with pegylated interferon alpha-2a ribavirin and amantadine sulphate versus placebo in untreated patients with chronic hepatitis C virus-genotype-1-infection The hypothesis was that there will be an increase in sustained response rate for triple therapy compared to current standard treatment
Detailed Description:
Primary Objective
Proof that a triple-therapy peginterferon alfa-2a ribavirin and amantadine sulphate dispensed over a period of 50 weeks improves the permanent virological efficacy by more than 10 as compared to a combination therapy with peginterferon alpha-2a and ribavirin defined as negative HCV-RNA result obtained by a molecular verification method eg Roche AmplicorTM HCV v20 sensitivity 50 IEml 24 weeks after the end of the therapy
Secondary Objectives
Verification of the initial virological efficacy up to week 12 defined as negative HCV-RNA test results by means of quantitative proof methods eg Roche AmplicorTM HCV Monitor v20 sensitivity 600 IEml
Biochemical efficacy defined by the serum GPT values 24 weeks after the end of the therapy
Virological efficacy measured on the basis of the HCV-RNA values at the end of the therapy
Biochemical efficacy defined by the serum GPT values at the end of the therapy
Proof that a triple-therapy peginterferon alfa-2a ribavirin and amantadine sulphate dispensed over a period of 50 weeks improves the permanent virological efficacy by more than 10 as compared to a combination therapy with peginterferon alpha-2a and ribavirin defined as negative HCV-RNA result obtained by a molecular verification method eg Roche AmplicorTM HCV v20 sensitivity 50 IEml 24 weeks after the end of the therapy
Secondary Objectives
Verification of the initial virological efficacy up to week 12 defined as negative HCV-RNA test results by means of quantitative proof methods eg Roche AmplicorTM HCV Monitor v20 sensitivity 600 IEml
Biochemical efficacy defined by the serum GPT values 24 weeks after the end of the therapy
Virological efficacy measured on the basis of the HCV-RNA values at the end of the therapy
Biochemical efficacy defined by the serum GPT values at the end of the therapy
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