Betaferon/ Betaseron (Interferon Beta-1b) in Patients With Chronic Viral Cardiomyopathy
NCT ID: NCT00185250
Last Updated: 2008-12-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
138 participants
INTERVENTIONAL
2002-12-31
2005-11-30
Brief Summary
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Betaferon (interferon beta-1b) is marketed for the treatment of Multiple Sclerosis already, but until now, it has not been proven whether it is also effective in patients with chronic viral myocardial disease.
This study will be conducted to examine the efficacy and safety of Betaferon in patients with this disease. The aim of the treatment is to eliminate the virus from the heart so that the heart function and clinical status can gradually improve.
Detailed Description
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Bayer Schering Pharma AG, Germany is the sponsor of the trial.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Arm 1
Interferon beta-1b (Betaferon/Betaseron, BAY86-5046)
2 MIU per application in week 1 and 4 MIU per application in weeks 2 to 24 given subcutaneously every other day
Arm 2
Interferon beta-1b (Betaferon/Betaseron, BAY86-5046)
2 MIU per application in week 1, 4 MIU per application in weeks 2 to 3 and 8 MIU per application in weeks 4 to 24 given subcutaneously every other day
Arm 3
Placebo
0.25 ml in week 1 and 0.50 ml in weeks 2 to 24 given subcutaneously every other day
Arm 4
Placebo
0.25 ml in week 1, 0.50 ml in weeks 2 to 3 and 1.00 ml in weeks 4 to 24 given subcutaneously every other day
Interventions
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Interferon beta-1b (Betaferon/Betaseron, BAY86-5046)
2 MIU per application in week 1 and 4 MIU per application in weeks 2 to 24 given subcutaneously every other day
Interferon beta-1b (Betaferon/Betaseron, BAY86-5046)
2 MIU per application in week 1, 4 MIU per application in weeks 2 to 3 and 8 MIU per application in weeks 4 to 24 given subcutaneously every other day
Placebo
0.25 ml in week 1 and 0.50 ml in weeks 2 to 24 given subcutaneously every other day
Placebo
0.25 ml in week 1, 0.50 ml in weeks 2 to 3 and 1.00 ml in weeks 4 to 24 given subcutaneously every other day
Eligibility Criteria
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Inclusion Criteria
* Being in a chronic (at least 6 month after the onset of clinical symptoms) and stable phase of the disease
* Impaired cardiac function
Exclusion Criteria
* Any other disease which could better explain the patient's clinical symptoms
* Any other severe and/or malignant disease.
* Suffering from convulsions, depression or suicidal ideas judged by a physician
* Serious viral or bacterial infections during the last weeks
* Pregnancy or lactation
18 Years
75 Years
ALL
No
Sponsors
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Bayer
INDUSTRY
Responsible Party
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Bayer Schering Pharma AG
Principal Investigators
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Bayer Study Director
Role: STUDY_DIRECTOR
Bayer
Locations
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Nantes, , France
Poitiers, , France
Bad Krozingen, Baden-Wurttemberg, Germany
Ulm, Baden-Wurttemberg, Germany
München, Bavaria, Germany
Brandenburg, Brandenburg, Germany
Hamburg, City state of Hamburg, Germany
Göttingen, Lower Saxony, Germany
Greifswald, Mecklenburg-Vorpommern, Germany
Rostock, Mecklenburg-Vorpommern, Germany
Bad Oeynhausen, North Rhine-Westphalia, Germany
Cologne, North Rhine-Westphalia, Germany
Dortmund, North Rhine-Westphalia, Germany
Essen, North Rhine-Westphalia, Germany
Münster, North Rhine-Westphalia, Germany
Wuppertal, North Rhine-Westphalia, Germany
Ludwigshafen am Rhein, Rhineland-Palatinate, Germany
Homburg, Saarland, Germany
Leipzig, Saxony, Germany
Halle, Saxony-Anhalt, Germany
Kiel, Schleswig-Holstein, Germany
Berlin, State of Berlin, Germany
Bad Berka, Thuringia, Germany
Bergamo, BG, Italy
Milan, MI, Italy
Pavia, , Italy
Warsaw, , Poland
Warsaw, , Poland
Madrid, Madrid, Spain
Gothenburg, , Sweden
Glasgow, , United Kingdom
Countries
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Other Identifiers
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305852
Identifier Type: -
Identifier Source: secondary_id
91115
Identifier Type: -
Identifier Source: org_study_id