Back to resultsBetaferon/ Betaseron (Interferon Beta-1b) in Patients With Chronic Viral Cardiomyopathy
Primary Purpose
Cardiomyopathies, Heart Diseases
Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Interferon beta-1b (Betaferon/Betaseron, BAY86-5046)
Interferon beta-1b (Betaferon/Betaseron, BAY86-5046)
Placebo
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Cardiomyopathies focused on measuring Cardiomyopathy, idiopathic chronic heart failure, Adenovirus, Enterovirus, Parvovirus
Eligibility 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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Experimental
Placebo Comparator
Placebo Comparator
Arm Label
Arm 1
Arm 2
Arm 3
Arm 4
Arm Description
Outcomes
Primary Outcome Measures
Presence of Adenovirus, Enterovirus and/or Parvovirus in endomyocardium
Secondary Outcome Measures
Changes in NYHA functional class
Six-minute walking test
Single clinical symptoms (dyspnea, fatigue, palpitation, atypical angina and angina pectoris)
Quality of life
Left ventricular ejection fraction at rest and on exertion
Regional and global wall motion, left ventricular enddiastolic diameter, and left ventricular endsystolic diameter
Inflammatory state in endomyocardial biopsies
Peripheral blood analyses for viral treatment effect and disease markers
Composite clinical endpoint
Hemodynamics
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00185250
Brief Title
Betaferon/ Betaseron (Interferon Beta-1b) in Patients With Chronic Viral Cardiomyopathy
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 Type
Interventional
2. Study Status
Record Verification Date
December 2008
Overall Recruitment Status
Completed
Study Start Date
December 2002 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
November 2005 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Bayer
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cardiomyopathies, Heart Diseases
Keywords
Cardiomyopathy, idiopathic chronic heart failure, Adenovirus, Enterovirus, Parvovirus
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
138 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Arm 1
Arm Type
Experimental
Arm Title
Arm 2
Arm Type
Experimental
Arm Title
Arm 3
Arm Type
Placebo Comparator
Arm Title
Arm 4
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Interferon beta-1b (Betaferon/Betaseron, BAY86-5046)
Intervention Description
2 MIU per application in week 1 and 4 MIU per application in weeks 2 to 24 given subcutaneously every other day
Intervention Type
Drug
Intervention Name(s)
Interferon beta-1b (Betaferon/Betaseron, BAY86-5046)
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
0.25 ml in week 1 and 0.50 ml in weeks 2 to 24 given subcutaneously every other day
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
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
Primary Outcome Measure Information:
Title
Presence of Adenovirus, Enterovirus and/or Parvovirus in endomyocardium
Time Frame
12 weeks after the end of a 24 weeks treatment
Secondary Outcome Measure Information:
Title
Changes in NYHA functional class
Time Frame
12 weeks and 24 weeks after the end of treatment
Title
Six-minute walking test
Time Frame
12 weeks and 24 weeks after the end of treatment
Title
Single clinical symptoms (dyspnea, fatigue, palpitation, atypical angina and angina pectoris)
Time Frame
12 weeks and 24 weeks after the end of treatment
Title
Quality of life
Time Frame
12 weeks and 24 weeks after the end of treatment
Title
Left ventricular ejection fraction at rest and on exertion
Time Frame
12 weeks after the end of treatment
Title
Regional and global wall motion, left ventricular enddiastolic diameter, and left ventricular endsystolic diameter
Time Frame
12 weeks after the end of treatment
Title
Inflammatory state in endomyocardial biopsies
Time Frame
12 weeks after the end of treatment
Title
Peripheral blood analyses for viral treatment effect and disease markers
Time Frame
12 weeks after the end of treatment
Title
Composite clinical endpoint
Time Frame
12 weeks and 24 weeks after the end of treatment
Title
Hemodynamics
Time Frame
12 weeks after the end of treatment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bayer Study Director
Organizational Affiliation
Bayer
Official's Role
Study Director
Facility Information:
City
Nantes
ZIP/Postal Code
44805
Country
France
City
Poitiers Cedex
ZIP/Postal Code
86021
Country
France
City
Bad Krozingen
State/Province
Baden-Württemberg
ZIP/Postal Code
79189
Country
Germany
City
Ulm
State/Province
Baden-Württemberg
ZIP/Postal Code
89075
Country
Germany
City
München
State/Province
Bayern
ZIP/Postal Code
80636
Country
Germany
City
Greifswald
State/Province
Mecklenburg-Vorpommern
ZIP/Postal Code
17489
Country
Germany
City
Rostock
State/Province
Mecklenburg-Vorpommern
ZIP/Postal Code
18057
Country
Germany
City
Göttingen
State/Province
Niedersachsen
ZIP/Postal Code
37075
Country
Germany
City
Bad Oeynhausen
State/Province
Nordrhein-Westfalen
ZIP/Postal Code
32545
Country
Germany
City
Dortmund
State/Province
Nordrhein-Westfalen
ZIP/Postal Code
44137
Country
Germany
City
Essen
State/Province
Nordrhein-Westfalen
ZIP/Postal Code
45147
Country
Germany
City
Köln
State/Province
Nordrhein-Westfalen
ZIP/Postal Code
50931
Country
Germany
City
Münster
State/Province
Nordrhein-Westfalen
ZIP/Postal Code
48149
Country
Germany
City
Wuppertal
State/Province
Nordrhein-Westfalen
ZIP/Postal Code
42117
Country
Germany
City
Ludwigshafen
State/Province
Rheinland-Pfalz
ZIP/Postal Code
67063
Country
Germany
City
Homburg
State/Province
Saarland
ZIP/Postal Code
66421
Country
Germany
City
Halle
State/Province
Sachsen-Anhalt
ZIP/Postal Code
06097
Country
Germany
City
Leipzig
State/Province
Sachsen
ZIP/Postal Code
04103
Country
Germany
City
Kiel
State/Province
Schleswig-Holstein
ZIP/Postal Code
24105
Country
Germany
City
Bad Berka
State/Province
Thüringen
ZIP/Postal Code
99437
Country
Germany
City
Berlin
ZIP/Postal Code
12200
Country
Germany
City
Brandenburg
ZIP/Postal Code
14770
Country
Germany
City
Hamburg
ZIP/Postal Code
20251
Country
Germany
City
Bergamo
State/Province
BG
ZIP/Postal Code
24128
Country
Italy
City
Milano
State/Province
MI
ZIP/Postal Code
20132
Country
Italy
City
Pavia
ZIP/Postal Code
27100
Country
Italy
City
Warszawa
ZIP/Postal Code
00-909
Country
Poland
City
Warszawa
ZIP/Postal Code
04628
Country
Poland
City
Madrid
ZIP/Postal Code
28040
Country
Spain
City
Göteborg
ZIP/Postal Code
413 45
Country
Sweden
City
Glasgow
ZIP/Postal Code
G11 6NT
Country
United Kingdom
12. IPD Sharing Statement
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Betaferon/ Betaseron (Interferon Beta-1b) in Patients With Chronic Viral Cardiomyopathy
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