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| Sponsor: | University Hospital, Saarland |
|---|---|
| Collaborator: |
Hoffmann-La Roche |
| Information provided by: | University Hospital, Saarland |
| ClinicalTrials.gov Identifier: | NCT00127777 |
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Hepatitis C, Chronic |
Drug: Amantadine sulphate (in addition to standard treatment) |
Phase IV |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Double-Blind Primary Purpose: Treatment |
| 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 |
| Estimated Enrollment: | 700 |
| Study Start Date: | July 2002 |
| Estimated Study Completion Date: | December 2006 |
Primary Objective:
Secondary Objectives:
Eligibility| Ages Eligible for Study: | 18 Years to 70 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
If one or more of the above inclusion criteria are not fulfilled, the patient is excluded from the study!
Exclusion Criteria:
Simultaneous therapy with budipine or other QT-extending medication such as:
If one or more of these exclusion criteria is fulfilled, the patient shall be excluded from the study!
Contacts and Locations
More Information
| ClinicalTrials.gov Identifier: | NCT00127777 History of Changes |
| Other Study ID Numbers: | ML17002 |
| Study First Received: | August 4, 2005 |
| Last Updated: | August 24, 2005 |
| Health Authority: | Germany: Federal Institute for Drugs and Medical Devices |
|
HCV genotype 1 peginterferon alfa-2a ribavirin amantadine treatment-naive |
|
Hepatitis Hepatitis A Hepatitis C Hepatitis C, Chronic Liver Diseases Digestive System Diseases Hepatitis, Viral, Human Virus Diseases Enterovirus Infections Picornaviridae Infections RNA Virus Infections Flaviviridae Infections Hepatitis, Chronic Amantadine Ribavirin |
Peginterferon alfa-2a Interferon-alpha Antiparkinson Agents Anti-Dyskinesia Agents Central Nervous System Agents Therapeutic Uses Pharmacologic Actions Antiviral Agents Anti-Infective Agents Dopamine Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Analgesics, Non-Narcotic Analgesics |