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

Heart Diseases Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00185250
• Other study ID #: 91115
• Secondary ID: 305852
• Status: Completed
• Phase: Phase 2
• First received: September 10, 2005
• Last updated: December 18, 2008
• Start date: December 2002
• Est. completion date: November 2005

Study information

• Verified date: December 2008
• Source: Bayer
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical DevicesItaly: National Monitoring Centre for Clinical Trials - Ministry of HealthFrance: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal ProductsSpain: Spanish Agency of MedicinesSweden: Medical Products AgencySwitzerland: SwissmedicUnited Kingdom: Medicines and Healthcare Products Regulatory AgencyUnited States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 138
• Est. completion date: November 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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 Design

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

Related Conditions & MeSH terms

• Cardiomyopathies
• Heart Diseases

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Bayer

Countries where clinical trial is conducted

France,  Germany,  Italy,  Poland,  Spain,  Sweden,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Presence of Adenovirus, Enterovirus and/or Parvovirus in endomyocardium		12 weeks after the end of a 24 weeks treatment	No
Secondary	Changes in NYHA functional class		12 weeks and 24 weeks after the end of treatment	No
Secondary	Six-minute walking test		12 weeks and 24 weeks after the end of treatment	No
Secondary	Single clinical symptoms (dyspnea, fatigue, palpitation, atypical angina and angina pectoris)		12 weeks and 24 weeks after the end of treatment	No
Secondary	Quality of life		12 weeks and 24 weeks after the end of treatment	No
Secondary	Left ventricular ejection fraction at rest and on exertion		12 weeks after the end of treatment	No
Secondary	Regional and global wall motion, left ventricular enddiastolic diameter, and left ventricular endsystolic diameter		12 weeks after the end of treatment	No
Secondary	Inflammatory state in endomyocardial biopsies		12 weeks after the end of treatment	No
Secondary	Peripheral blood analyses for viral treatment effect and disease markers		12 weeks after the end of treatment	No
Secondary	Composite clinical endpoint		12 weeks and 24 weeks after the end of treatment	No
Secondary	Hemodynamics		12 weeks after the end of treatment	No

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