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

NCT00185250 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 138

Last updated 2008-12-19

No results posted yet for this study

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.

Conditions

  • Cardiomyopathies
  • Heart Diseases

Interventions

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

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

Sponsors & Collaborators

Principal Investigators

  • Bayer Study Director · Bayer

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2002-12-31
Completion
2005-11-30

Countries

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

Study Locations

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00185250 on ClinicalTrials.gov