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| ID | Type | Description | Link |
|---|---|---|---|
| 305852 |
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Chronic viral cardiomyopathy is a disease where the cardiac muscle is attacked by a virus and this may result in a reduction in the output of the heart (pump function) thereby causing complaints such as chest pain, shortness of breath and palpitations.
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.
The study has previously been posted by Schering AG, Germany. Schering AG, Germany has been renamed to Bayer Schering Pharma AG, Germany.
Bayer Schering Pharma AG, Germany is the sponsor of the trial.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm 1 | Experimental |
| |
| Arm 2 | Experimental |
| |
| Arm 3 | Placebo Comparator |
| |
| Arm 4 | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Interferon beta-1b (Betaferon/Betaseron, BAY86-5046) | Drug | 2 MIU per application in week 1 and 4 MIU per application in weeks 2 to 24 given subcutaneously every other day |
|
| Measure | Description | Time Frame |
|---|---|---|
| Presence of Adenovirus, Enterovirus and/or Parvovirus in endomyocardium | 12 weeks after the end of a 24 weeks treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in NYHA functional class | 12 weeks and 24 weeks after the end of treatment | |
| Six-minute walking test | 12 weeks and 24 weeks after the end of treatment | |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Bayer Study Director | Bayer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Nantes | 44805 | France | ||||
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| Interferon beta-1b (Betaferon/Betaseron, BAY86-5046) | Drug | 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 | Drug | 0.25 ml in week 1 and 0.50 ml in weeks 2 to 24 given subcutaneously every other day |
|
| Placebo | Drug | 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 |
|
| Single clinical symptoms (dyspnea, fatigue, palpitation, atypical angina and angina pectoris) |
| 12 weeks and 24 weeks after the end of treatment |
| Quality of life | 12 weeks and 24 weeks after the end of treatment |
| Left ventricular ejection fraction at rest and on exertion | 12 weeks after the end of treatment |
| Regional and global wall motion, left ventricular enddiastolic diameter, and left ventricular endsystolic diameter | 12 weeks after the end of treatment |
| Inflammatory state in endomyocardial biopsies | 12 weeks after the end of treatment |
| Peripheral blood analyses for viral treatment effect and disease markers | 12 weeks after the end of treatment |
| Composite clinical endpoint | 12 weeks and 24 weeks after the end of treatment |
| Hemodynamics | 12 weeks after the end of treatment |
| Poitiers |
| 86021 |
| France |
| Bad Krozingen | Baden-Wurttemberg | 79189 | Germany |
| Ulm | Baden-Wurttemberg | 89075 | Germany |
| München | Bavaria | 80636 | Germany |
| Brandenburg an der Havel | Brandenburg | 14770 | Germany |
| Hamburg | Free and Hanseatic City of Hamburg | 20251 | Germany |
| Göttingen | Lower Saxony | 37075 | Germany |
| Greifswald | Mecklenburg-Vorpommern | 17489 | Germany |
| Rostock | Mecklenburg-Vorpommern | 18057 | Germany |
| Bad Oeynhausen | North Rhine-Westphalia | 32545 | Germany |
| Cologne | North Rhine-Westphalia | 50931 | Germany |
| Dortmund | North Rhine-Westphalia | 44137 | Germany |
| Essen | North Rhine-Westphalia | 45147 | Germany |
| Münster | North Rhine-Westphalia | 48149 | Germany |
| Wuppertal | North Rhine-Westphalia | 42117 | Germany |
| Ludwigshafen am Rhein | Rhineland-Palatinate | 67063 | Germany |
| Homburg | Saarland | 66421 | Germany |
| Leipzig | Saxony | 04103 | Germany |
| Halle | Saxony-Anhalt | 06097 | Germany |
| Kiel | Schleswig-Holstein | 24105 | Germany |
| Berlin | State of Berlin | 12200 | Germany |
| Bad Berka | Thuringia | 99437 | Germany |
| Bergamo | BG | 24128 | Italy |
| Milan | MI | 20132 | Italy |
| Pavia | 27100 | Italy |
| Warsaw | 00-909 | Poland |
| Warsaw | 04628 | Poland |
| Madrid | Madrid | 28040 | Spain |
| Gothenburg | 413 45 | Sweden |
| Glasgow | G11 6NT | United Kingdom |
| ID | Term |
|---|---|
| D009202 | Cardiomyopathies |
| D006331 | Heart Diseases |
| D000257 | Adenoviridae Infections |
| D004769 | Enterovirus Infections |
| D010322 | Parvoviridae Infections |
| ID | Term |
|---|---|
| D002318 | Cardiovascular Diseases |
| D004266 | DNA Virus Infections |
| D014777 | Virus Diseases |
| D007239 | Infections |
| D010850 | Picornaviridae Infections |
| D012327 | RNA Virus Infections |
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| ID | Term |
|---|---|
| D000068576 | Interferon beta-1b |
| ID | Term |
|---|---|
| D016899 | Interferon-beta |
| D007370 | Interferon Type I |
| D007372 | Interferons |
| D016207 | Cytokines |
| D036341 | Intercellular Signaling Peptides and Proteins |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D011506 | Proteins |
| D001685 | Biological Factors |
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