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

ID: NCT00185250
Status: Completed
Phase: Phase 2
Start Date: December 01, 2002
First Submitted: September 10, 2005
Last Updated: December 18, 2008
Results: N/A
Organization: Bayer
Sponsors & Collaborators: Bayer
Location: France, Germany, Italy, Poland, Spain, Sweden, United Kingdom
Conditions: Cardiomyopathies, Heart Diseases
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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.

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.
Condition or disease Intervention/treatment Phase

Cardiomyopathies

Heart Diseases

Drug: Interferon beta-1b (Betaferon/Betaseron, BAY86-5046)
Other Names
Drug: Interferon beta-1b (Betaferon/Betaseron, BAY86-5046)
Other Names
Drug: Placebo
Other Names
Drug: Placebo
Other Names
Phase 2

Tracking Information

First Submitted DateSeptember 10, 2005
Last Update Posted DateDecember 18, 2008
Start DateDecember 01, 2002
Actual Completion DateNovember 01, 2005
Primary Completion DateN/A
Results First Submitted DateN/A
Received Results Disposit DateN/A

Current Primary Outcome Measures

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

Original Primary Outcome Measures

Not Available

Current Secondary Outcome Measures

  • Changes in NYHA functional class [Time Frame: 12 weeks and 24 weeks after the end of treatment]

  • Six-minute walking test [Time Frame: 12 weeks and 24 weeks after the end of treatment]

  • Single clinical symptoms (dyspnea, fatigue, palpitation, atypical angina and angina pectoris) [Time Frame: 12 weeks and 24 weeks after the end of treatment]

  • Quality of life [Time Frame: 12 weeks and 24 weeks after the end of treatment]

  • Left ventricular ejection fraction at rest and on exertion [Time Frame: 12 weeks after the end of treatment]

  • Regional and global wall motion, left ventricular enddiastolic diameter, and left ventricular endsystolic diameter [Time Frame: 12 weeks after the end of treatment]

  • Inflammatory state in endomyocardial biopsies [Time Frame: 12 weeks after the end of treatment]

  • Peripheral blood analyses for viral treatment effect and disease markers [Time Frame: 12 weeks after the end of treatment]

  • Composite clinical endpoint [Time Frame: 12 weeks and 24 weeks after the end of treatment]

  • Hemodynamics [Time Frame: 12 weeks after the end of treatment]

Original Secondary Outcome Measures

Not Available

Study Design

Brief TitleBetaferon/ Betaseron (Interferon Beta-1b) in Patients With Chronic Viral Cardiomyopathy
Official TitleDouble-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
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.

Study TypeInterventional
Study PhasePhase 2
Estimated Enrollment
138
Allocation
Randomized
Interventional Model
Parallel Assignment
Masking
Triple
Primary Purpose
Treatment
Conditions
Cardiomyopathies
Heart Diseases
Target Follow-Up Duration N/A
Biospecimen:
N/A
Sampling MethodN/A
Study PopulationN/A
Intervention
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

Other Names
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

Other Names
Drug: Placebo

0.25 ml in week 1 and 0.50 ml in weeks 2 to 24 given subcutaneously every other day

Other Names
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

Other Names
Study Groups/Cohorts
Arm 1

Arm 2

Arm 3

Arm 4

Study Arms
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

Arm Intervention/Treatment
Experimental Arm 1
Drug : Interferon beta-1b (Betaferon/Betaseron, BAY86-5046)
Experimental Arm 2
Drug : Interferon beta-1b (Betaferon/Betaseron, BAY86-5046)
Placebo Comparator Arm 3
Drug : Placebo
Placebo Comparator Arm 4
Drug : Placebo

Recruitment Information

Recruitment Status:Completed
Enrollment138
Completion DateNovember 01, 2005
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
GenderAll
Age18 Years to 75 Years
Accepts Healthy VolunteersNo
Contacts
Not Available
Listed Location Countries
France
Germany
Italy
Poland
Spain
Sweden
United Kingdom

Administrative Information

NCT Number:NCT00185250
Other Study ID Numbers
91115
305852
Has Data Monitoring CommitteeYes
U.S. FDA-regulated Product Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Device Product Not Approved or Cleared by U.S. FDA: No
IPD Sharing Statement
Not Available
Responsible PartyTherapeutic Area Head,
Study Sponsor
Bayer
Collaborators
Not Available
Investigators
Study Director
Bayer Study Director
Bayer