Peginterferon Alfa-2a, Ribavirin, Amantadine/Placebo in Hepatitis C Virus (HCV)-Genotype-1-Infection (PRAMA)
The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2005 by University Hospital, Saarland.
Recruitment status was Active, not recruiting
Information provided by:
University Hospital, Saarland
First received: August 4, 2005
Last updated: August 24, 2005
Last verified: August 2005
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.
Hepatitis C, Chronic
Drug: Amantadine sulphate (in addition to standard treatment)
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Primary Purpose: Treatment
||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
Primary Outcome Measures:
- Proof that peginterferon alfa-2a, ribavirin and amantadine sulphate over a period of 50 weeks improves the permanent virological efficacy by more than 10% compared to peginterferon alfa-2a and ribavirin
Secondary Outcome Measures:
- 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
| Estimated Enrollment:
| Study Start Date:
| Estimated Study Completion Date:
- 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.
- 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.
|Ages Eligible for Study:
||18 Years to 70 Years
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- Female and male subjects over 18 years of age and below 70 years of age
- Serological indication of chronic hepatitis C infection with positive anti-HCV test and serum HCV-RNA quantification >600 IE/ml by means of quantitative proof methods, e.g. Roche AmplicorTM HCV Monitor test, v.2.0.
- Untreated patients with HCV-induced chronic infection.
- Indication of a genotype HCV-1 on the basis of the reverse hybridizing assay Inno LiPA from Bayer Versant (Innogenetics).
- Increased GPT serum level on at least one determination date within the 56-day screening phase prior to start of administration of study medication.
- Histological identification of inflammatory activity in the liver, with or without an indication of compensated cirrhosis, during the 24 months prior to start of the study.
- Compensated liver disease (Child-Pugh Grade A).
- Negative urine or serum pregnancy test in fertile female subjects within 24 hours before taking the first dose of study medication.
- During the administration of study medication and for 24 weeks after the treatment has stopped, patients must apply two approved contraception methods, one of which must have a barrier effect on the male, e.g. condom.
If one or more of the above inclusion criteria are not fulfilled, the patient is excluded from the study!
If one or more of these exclusion criteria is fulfilled, the patient shall be excluded from the study!
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00127777
University Hospital, Saarland
||Stefan Zeuzem, MD
||Saarland University Hospital
No publications provided
History of Changes
|Other Study ID Numbers:
|Study First Received:
||August 4, 2005
||August 24, 2005
||Germany: Federal Institute for Drugs and Medical Devices
Keywords provided by University Hospital, Saarland:
HCV genotype 1
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on September 11, 2014
Hepatitis C, Chronic
Digestive System Diseases
Hepatitis, Viral, Human
RNA Virus Infections
Central Nervous System Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs