Status:
COMPLETED
Betaferon/ Betaseron (Interferon Beta-1b) in Patients With Chronic Viral Cardiomyopathy
Lead Sponsor:
Bayer
Conditions:
Cardiomyopathies
Heart Diseases
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
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 ...
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 Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
December 1 2002
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2005
Estimated Enrollment :
138 Patients enrolled
Trial Details
Trial ID
NCT00185250
Start Date
December 1 2002
End Date
November 1 2005
Last Update
December 19 2008
Active Locations (31)
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1
Nantes, France, 44805
2
Poitiers, France, 86021
3
Bad Krozingen, Baden-Wurttemberg, Germany, 79189
4
Ulm, Baden-Wurttemberg, Germany, 89075