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

Sponsor:	Bayer
Information provided by:	Bayer
ClinicalTrials.gov Identifier:	NCT00185250

Purpose

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.

Condition	Intervention	Phase
Cardiomyopathies Heart Diseases	Drug: Interferon beta-1b (Betaferon/Betaseron, BAY86-5046) Drug: Placebo	Phase II

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator, Outcomes Assessor) Primary Purpose: Treatment
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

Resource links provided by NLM:

MedlinePlus related topics: Cardiomyopathy Heart Diseases

Drug Information available for: Interferon beta Interferon-beta Interferon beta-1b Interferons

U.S. FDA Resources

Further study details as provided by Bayer:

Primary Outcome Measures:

Presence of Adenovirus, Enterovirus and/or Parvovirus in endomyocardium [ Time Frame: 12 weeks after the end of a 24 weeks treatment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Changes in NYHA functional class [ Time Frame: 12 weeks and 24 weeks after the end of treatment ] [ Designated as safety issue: No ]
Six-minute walking test [ Time Frame: 12 weeks and 24 weeks after the end of treatment ] [ Designated as safety issue: No ]
Single clinical symptoms (dyspnea, fatigue, palpitation, atypical angina and angina pectoris) [ Time Frame: 12 weeks and 24 weeks after the end of treatment ] [ Designated as safety issue: No ]
Quality of life [ Time Frame: 12 weeks and 24 weeks after the end of treatment ] [ Designated as safety issue: No ]
Left ventricular ejection fraction at rest and on exertion [ Time Frame: 12 weeks after the end of treatment ] [ Designated as safety issue: No ]
Regional and global wall motion, left ventricular enddiastolic diameter, and left ventricular endsystolic diameter [ Time Frame: 12 weeks after the end of treatment ] [ Designated as safety issue: No ]
Inflammatory state in endomyocardial biopsies [ Time Frame: 12 weeks after the end of treatment ] [ Designated as safety issue: No ]
Peripheral blood analyses for viral treatment effect and disease markers [ Time Frame: 12 weeks after the end of treatment ] [ Designated as safety issue: No ]
Composite clinical endpoint [ Time Frame: 12 weeks and 24 weeks after the end of treatment ] [ Designated as safety issue: No ]
Hemodynamics [ Time Frame: 12 weeks after the end of treatment ] [ Designated as safety issue: No ]

Enrollment:	138
Study Start Date:	December 2002
Study Completion Date:	November 2005

Arms	Assigned Interventions
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

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

Ages Eligible for Study:	18 Years to 75 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00185250

Locations

France

Nantes, France, 44805

Poitiers Cedex, France, 86021
Germany

Bad Krozingen, Baden-Württemberg, Germany, 79189

Ulm, Baden-Württemberg, Germany, 89075

München, Bayern, Germany, 80636

Greifswald, Mecklenburg-Vorpommern, Germany, 17489

Rostock, Mecklenburg-Vorpommern, Germany, 18057

Göttingen, Niedersachsen, Germany, 37075

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

Ludwigshafen, Rheinland-Pfalz, Germany, 67063

Homburg, Saarland, Germany, 66421

Halle, Sachsen-Anhalt, Germany, 06097

Leipzig, Sachsen, Germany, 04103

Kiel, Schleswig-Holstein, Germany, 24105

Bad Berka, Thüringen, Germany, 99437

Berlin, Germany, 12200

Brandenburg, Germany, 14770

Hamburg, Germany, 20251
Italy

Bergamo, BG, Italy, 24128

Milano, MI, Italy, 20132

Pavia, Italy, 27100
Poland

Warszawa, Poland, 04628

Warszawa, Poland, 00-909
Spain

Madrid, Spain, 28040
Sweden

Göteborg, Sweden, 413 45
United Kingdom

Glasgow, United Kingdom, G11 6NT

Sponsors and Collaborators

Bayer

Investigators

Study Director:

Bayer Study Director

Bayer

More Information

Additional Information:

Click here and search for drug information provided by the FDA This link exits the ClinicalTrials.gov site

Click here and search for information on any recalls, market or product safety alerts by the FDA which might have occurred with this product This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Therapeutic Area Head, Bayer Schering Pharma AG
ClinicalTrials.gov Identifier:	NCT00185250 History of Changes
Other Study ID Numbers:	91115, 305852
Study First Received:	September 10, 2005
Last Updated:	December 18, 2008
Health Authority:	Germany: Federal Institute for Drugs and Medical Devices; Italy: National Monitoring Centre for Clinical Trials - Ministry of Health; France: Afssaps - French Health Products Safety Agency; Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products; Spain: Spanish Agency of Medicines; Sweden: Medical Products Agency; Switzerland: Swissmedic; United Kingdom: Medicines and Healthcare Products Regulatory Agency; United States: Food and Drug Administration

Keywords provided by Bayer:

Cardiomyopathy
idiopathic chronic heart failure
Adenovirus
Enterovirus
Parvovirus

Additional relevant MeSH terms:

Heart Diseases
Cardiomyopathies
Cardiovascular Diseases
Interferon-beta
Interferons
Interferon beta-1b
Antiviral Agents

Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Immunologic Factors
Physiological Effects of Drugs
Antineoplastic Agents
Adjuvants, Immunologic

ClinicalTrials.gov processed this record on February 09, 2012