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Betaferon/ Betaseron (Interferon Beta-1b) in Patients With Chronic Viral Cardiomyopathy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00185250
Recruitment Status : Completed
First Posted : September 16, 2005
Last Update Posted : December 19, 2008
Sponsor:
Information provided by:
Bayer

Study Description
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Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Cardiomyopathies Heart Diseases Drug: Interferon beta-1b (Betaferon/Betaseron, BAY86-5046) Drug: Placebo Phase 2

Detailed Description:

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 138 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Double-Blind, Placebo-Controlled, Randomized, Parallel Group, Multicenter Study to Evaluate Efficacy and Safety of 4 and 8 Million Units Betaferon®/Betaseron® (Interferon Beta-1b) Given Subcutaneously Every Other Day Over 24 Weeks in Patients With Chronic Viral Cardiomyopathy
Study Start Date : December 2002
Actual Study Completion Date : November 2005

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cardiomyopathy

Arms and Interventions
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Arm Intervention/treatment
Experimental: Arm 1 Drug: 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
Experimental: Arm 2 Drug: 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 Comparator: Arm 3 Drug: Placebo
0.25 ml in week 1 and 0.50 ml in weeks 2 to 24 given subcutaneously every other day
Placebo Comparator: Arm 4 Drug: 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


Outcome Measures
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Primary Outcome Measures :
  1. Presence of Adenovirus, Enterovirus and/or Parvovirus in endomyocardium [ Time Frame: 12 weeks after the end of a 24 weeks treatment ]

Secondary Outcome Measures :
  1. Changes in NYHA functional class [ Time Frame: 12 weeks and 24 weeks after the end of treatment ]
  2. Six-minute walking test [ Time Frame: 12 weeks and 24 weeks after the end of treatment ]
  3. Single clinical symptoms (dyspnea, fatigue, palpitation, atypical angina and angina pectoris) [ Time Frame: 12 weeks and 24 weeks after the end of treatment ]
  4. Quality of life [ Time Frame: 12 weeks and 24 weeks after the end of treatment ]
  5. Left ventricular ejection fraction at rest and on exertion [ Time Frame: 12 weeks after the end of treatment ]
  6. Regional and global wall motion, left ventricular enddiastolic diameter, and left ventricular endsystolic diameter [ Time Frame: 12 weeks after the end of treatment ]
  7. Inflammatory state in endomyocardial biopsies [ Time Frame: 12 weeks after the end of treatment ]
  8. Peripheral blood analyses for viral treatment effect and disease markers [ Time Frame: 12 weeks after the end of treatment ]
  9. Composite clinical endpoint [ Time Frame: 12 weeks and 24 weeks after the end of treatment ]
  10. Hemodynamics [ Time Frame: 12 weeks after the end of treatment ]

Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Unexplained heart with evidence of Adeno-, Entero- and/or Parvoviruses which must be identified directly in the heart tissue
  • 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:

  • Severe (decompensated) or acute heart failure.
  • 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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00185250


Locations
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France
Nantes, France, 44805
Poitiers Cedex, France, 86021
Germany
Bad Krozingen, Baden-Württemberg, Germany, 79189
Ulm, Baden-Württemberg, Germany, 89075
München, Bayern, Germany, 80636
Greifswald, Mecklenburg-Vorpommern, Germany, 17489
Rostock, Mecklenburg-Vorpommern, Germany, 18057
Göttingen, Niedersachsen, Germany, 37075
Bad Oeynhausen, Nordrhein-Westfalen, Germany, 32545
Dortmund, Nordrhein-Westfalen, Germany, 44137
Essen, Nordrhein-Westfalen, Germany, 45147
Köln, Nordrhein-Westfalen, Germany, 50931
Münster, Nordrhein-Westfalen, Germany, 48149
Wuppertal, Nordrhein-Westfalen, Germany, 42117
Ludwigshafen, Rheinland-Pfalz, Germany, 67063
Homburg, Saarland, Germany, 66421
Halle, Sachsen-Anhalt, Germany, 06097
Leipzig, Sachsen, Germany, 04103
Kiel, Schleswig-Holstein, Germany, 24105
Bad Berka, Thüringen, Germany, 99437
Berlin, Germany, 12200
Brandenburg, Germany, 14770
Hamburg, Germany, 20251
Italy
Bergamo, BG, Italy, 24128
Milano, MI, Italy, 20132
Pavia, Italy, 27100
Poland
Warszawa, Poland, 00-909
Warszawa, Poland, 04628
Spain
Madrid, Spain, 28040
Sweden
Göteborg, Sweden, 413 45
United Kingdom
Glasgow, United Kingdom, G11 6NT
Sponsors and Collaborators
Bayer
Investigators
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Study Director: Bayer Study Director Bayer
More Information
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Responsible Party: Therapeutic Area Head, Bayer Schering Pharma AG
ClinicalTrials.gov Identifier: NCT00185250    
Other Study ID Numbers: 91115
305852
First Posted: September 16, 2005    Key Record Dates
Last Update Posted: December 19, 2008
Last Verified: December 2008
Keywords provided by Bayer:
Cardiomyopathy
idiopathic chronic heart failure
Adenovirus
Enterovirus
Parvovirus
Additional relevant MeSH terms:
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Heart Diseases
Cardiomyopathies
Cardiovascular Diseases
Interferons
Interferon-beta
Interferon beta-1b
 Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Immunologic Factors
Physiological Effects of Drugs
Adjuvants, Immunologic