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

This study has been completed.
Sponsor:
Information provided by:
Bayer
ClinicalTrials.gov Identifier:
NCT00185250
First received: September 10, 2005
Last updated: December 18, 2008
Last verified: December 2008
  Purpose

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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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

Resource links provided by NLM:


Further study details as provided by Bayer:

Primary Outcome Measures:
  • Presence of Adenovirus, Enterovirus and/or Parvovirus in endomyocardium [ Time Frame: 12 weeks after the end of a 24 weeks treatment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Changes in NYHA functional class [ Time Frame: 12 weeks and 24 weeks after the end of treatment ] [ Designated as safety issue: No ]
  • Six-minute walking test [ Time Frame: 12 weeks and 24 weeks after the end of treatment ] [ Designated as safety issue: No ]
  • Single clinical symptoms (dyspnea, fatigue, palpitation, atypical angina and angina pectoris) [ Time Frame: 12 weeks and 24 weeks after the end of treatment ] [ Designated as safety issue: No ]
  • Quality of life [ Time Frame: 12 weeks and 24 weeks after the end of treatment ] [ Designated as safety issue: No ]
  • Left ventricular ejection fraction at rest and on exertion [ Time Frame: 12 weeks after the end of treatment ] [ Designated as safety issue: No ]
  • Regional and global wall motion, left ventricular enddiastolic diameter, and left ventricular endsystolic diameter [ Time Frame: 12 weeks after the end of treatment ] [ Designated as safety issue: No ]
  • Inflammatory state in endomyocardial biopsies [ Time Frame: 12 weeks after the end of treatment ] [ Designated as safety issue: No ]
  • Peripheral blood analyses for viral treatment effect and disease markers [ Time Frame: 12 weeks after the end of treatment ] [ Designated as safety issue: No ]
  • Composite clinical endpoint [ Time Frame: 12 weeks and 24 weeks after the end of treatment ] [ Designated as safety issue: No ]
  • Hemodynamics [ Time Frame: 12 weeks after the end of treatment ] [ Designated as safety issue: No ]

Enrollment: 138
Study Start Date: December 2002
Study Completion Date: November 2005
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00185250

Locations
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, 04628
Warszawa, Poland, 00-909
Spain
Madrid, Spain, 28040
Sweden
Göteborg, Sweden, 413 45
United Kingdom
Glasgow, United Kingdom, G11 6NT
Sponsors and Collaborators
Bayer
Investigators
Study Director: Bayer Study Director Bayer
  More Information

Additional Information:
No publications provided

Responsible Party: Therapeutic Area Head, Bayer Schering Pharma AG
ClinicalTrials.gov Identifier: NCT00185250     History of Changes
Other Study ID Numbers: 91115, 305852
Study First Received: September 10, 2005
Last Updated: December 18, 2008
Health Authority: Germany: Federal Institute for Drugs and Medical Devices
Italy: National Monitoring Centre for Clinical Trials - Ministry of Health
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Spain: Spanish Agency of Medicines
Sweden: Medical Products Agency
Switzerland: Swissmedic
United Kingdom: Medicines and Healthcare Products Regulatory Agency
United States: Food and Drug Administration

Keywords provided by Bayer:
Cardiomyopathy
idiopathic chronic heart failure
Adenovirus
Enterovirus
Parvovirus

Additional relevant MeSH terms:
Heart Diseases
Cardiomyopathies
Cardiovascular Diseases
Interferon-beta
Interferons
Interferon beta-1b
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Immunologic Factors
Physiological Effects of Drugs
Antineoplastic Agents
Adjuvants, Immunologic

ClinicalTrials.gov processed this record on July 28, 2014