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

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.

Study Overview

• Status: Completed
• Conditions: Heart Diseases; Cardiomyopathies
• Intervention / Treatment: Drug: Interferon beta-1b (Betaferon/Betaseron, BAY86-5046); Drug: Interferon beta-1b (Betaferon/Betaseron, BAY86-5046); Drug: Placebo; Drug: Placebo

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 Type: Interventional
• Enrollment (Actual): 138
• Phase: Phase 2

Contacts and Locations

Study Locations

• France
  • Nantes, France, 44805
  • Poitiers Cedex, France, 86021
• Germany
  • Berlin, Germany, 12200
  • Brandenburg, Germany, 14770
  • Hamburg, Germany, 20251
  • Baden-Württemberg
    • Bad Krozingen, Baden-Württemberg, Germany, 79189
    • Ulm, Baden-Württemberg, Germany, 89075
  • Bayern
    • München, Bayern, Germany, 80636
  • Mecklenburg-Vorpommern
    • Greifswald, Mecklenburg-Vorpommern, Germany, 17489
    • Rostock, Mecklenburg-Vorpommern, Germany, 18057
  • Niedersachsen
    • Göttingen, Niedersachsen, Germany, 37075
  • Nordrhein-Westfalen
    • 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
  • Rheinland-Pfalz
    • Ludwigshafen, Rheinland-Pfalz, Germany, 67063
  • Saarland
    • Homburg, Saarland, Germany, 66421
  • Sachsen
    • Leipzig, Sachsen, Germany, 04103
  • Sachsen-Anhalt
    • Halle, Sachsen-Anhalt, Germany, 06097
  • Schleswig-Holstein
    • Kiel, Schleswig-Holstein, Germany, 24105
  • Thüringen
    • Bad Berka, Thüringen, Germany, 99437
• Italy
  • Pavia, Italy, 27100
  • BG
    • Bergamo, BG, Italy, 24128
  • MI
    • Milano, MI, Italy, 20132
• Poland
  • Warszawa, Poland, 00-909
  • Warszawa, Poland, 04628
• Spain
  • Madrid, Spain, 28040
• Sweden
  • Göteborg, Sweden, 413 45
• United Kingdom
  • Glasgow, United Kingdom, G11 6NT

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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; 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
Experimental: Arm 2	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; 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; 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
Placebo Comparator: Arm 4	Drug: Placebo; 0.25 ml in week 1 and 0.50 ml in weeks 2 to 24 given subcutaneously every other day; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Presence of Adenovirus, Enterovirus and/or Parvovirus in endomyocardium	12 weeks after the end of a 24 weeks treatment

Secondary Outcome Measures

Outcome Measure	Time Frame
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
Regional and global wall motion, left ventricular enddiastolic diameter, and left ventricular endsystolic diameter	12 weeks after the end of treatment
Inflammatory state in endomyocardial biopsies	12 weeks after the end of treatment
Peripheral blood analyses for viral treatment effect and disease markers	12 weeks after the end of treatment
Composite clinical endpoint	12 weeks and 24 weeks after the end of treatment
Hemodynamics	12 weeks after the end of treatment

Collaborators and Investigators

• Sponsor: Bayer

Study record dates

Study Major Dates

• Study Start: December 1, 2002
• Study Completion (Actual): November 1, 2005

Study Registration Dates

• First Submitted: September 10, 2005
• First Submitted That Met QC Criteria: September 10, 2005
• First Posted (Estimate): September 16, 2005

Study Record Updates

• Last Update Posted (Estimate): December 19, 2008
• Last Update Submitted That Met QC Criteria: December 18, 2008
• Last Verified: December 1, 2008

More Information

Terms related to this study

• Keywords: Cardiomyopathy; Enterovirus; Adenovirus; idiopathic chronic heart failure; Parvovirus
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Heart Diseases; Cardiomyopathies; Physiological Effects of Drugs; Anti-Infective Agents; Antiviral Agents; Antineoplastic Agents; Immunologic Factors; Adjuvants, Immunologic; Interferons; Interferon-beta; Interferon beta-1b
• Other Study ID Numbers: 91115; 305852