Betaferon/ Betaseron (Interferon Beta-1b) in Patients With Chronic Viral Cardiomyopathy
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
2 other identifiers
interventional
138
7 countries
31
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Dec 2002
Typical duration for phase_2
31 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2002
CompletedFirst Submitted
Initial submission to the registry
September 10, 2005
CompletedFirst Posted
Study publicly available on registry
September 16, 2005
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2005
CompletedDecember 19, 2008
December 1, 2008
September 10, 2005
December 18, 2008
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Presence of Adenovirus, Enterovirus and/or Parvovirus in endomyocardium
12 weeks after the end of a 24 weeks treatment
Secondary Outcomes (10)
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
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
- +5 more secondary outcomes
Study Arms (4)
Arm 1
EXPERIMENTALArm 2
EXPERIMENTALArm 3
PLACEBO COMPARATORArm 4
PLACEBO COMPARATORInterventions
2 MIU per application in week 1 and 4 MIU per application in weeks 2 to 24 given subcutaneously every other day
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Bayerlead
Study Sites (31)
Unknown Facility
Nantes, 44805, France
Unknown Facility
Poitiers, 86021, France
Unknown Facility
Bad Krozingen, Baden-Wurttemberg, 79189, Germany
Unknown Facility
Ulm, Baden-Wurttemberg, 89075, Germany
Unknown Facility
München, Bavaria, 80636, Germany
Unknown Facility
Brandenburg, Brandenburg, 14770, Germany
Unknown Facility
Hamburg, Hamburg, 20251, Germany
Unknown Facility
Göttingen, Lower Saxony, 37075, Germany
Unknown Facility
Greifswald, Mecklenburg-Vorpommern, 17489, Germany
Unknown Facility
Rostock, Mecklenburg-Vorpommern, 18057, Germany
Unknown Facility
Bad Oeynhausen, North Rhine-Westphalia, 32545, Germany
Unknown Facility
Cologne, North Rhine-Westphalia, 50931, Germany
Unknown Facility
Dortmund, North Rhine-Westphalia, 44137, Germany
Unknown Facility
Essen, North Rhine-Westphalia, 45147, Germany
Unknown Facility
Münster, North Rhine-Westphalia, 48149, Germany
Unknown Facility
Wuppertal, North Rhine-Westphalia, 42117, Germany
Unknown Facility
Ludwigshafen am Rhein, Rhineland-Palatinate, 67063, Germany
Unknown Facility
Homburg, Saarland, 66421, Germany
Unknown Facility
Leipzig, Saxony, 04103, Germany
Unknown Facility
Halle, Saxony-Anhalt, 06097, Germany
Unknown Facility
Kiel, Schleswig-Holstein, 24105, Germany
Unknown Facility
Berlin, State of Berlin, 12200, Germany
Unknown Facility
Bad Berka, Thuringia, 99437, Germany
Unknown Facility
Bergamo, BG, 24128, Italy
Unknown Facility
Milan, MI, 20132, Italy
Unknown Facility
Pavia, 27100, Italy
Unknown Facility
Warsaw, 00-909, Poland
Unknown Facility
Warsaw, 04628, Poland
Unknown Facility
Madrid, Madrid, 28040, Spain
Unknown Facility
Gothenburg, 413 45, Sweden
Unknown Facility
Glasgow, G11 6NT, United Kingdom
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Bayer Study Director
Bayer
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
September 10, 2005
First Posted
September 16, 2005
Study Start
December 1, 2002
Study Completion
November 1, 2005
Last Updated
December 19, 2008
Record last verified: 2008-12