NCT00127777

Peginterferon Alfa-2a, Ribavirin, Amantadine/Placebo in Hepatitis C Virus (HCV)-Genotype-1-Infection (PRAMA)

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
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 700 (planned)
• Sponsor: University Hospital, Saarland · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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 (e.g. Roche AmplicorTM HCV, v.2.0, sensitivity \<50 IE/ml) 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, e.g. Roche AmplicorTM HCV Monitor v.2.0 (sensitivity \<600 IE/ml). * 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.

Conditions

• Hepatitis C, Chronic

Interventions

Type	Name	Description
DRUG	Amantadine sulphate (in addition to standard treatment)

Timeline

• Start date: 2002-07-01
• Completion: 2006-12-01
• First posted: 2005-08-08
• Last updated: 2005-08-25