NCT00185250

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 138 (actual)
• Sponsor: Bayer · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Cardiomyopathies
• Heart Diseases

Interventions

Type	Name	Description
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

Timeline

• Start date: 2002-12-01
• Completion: 2005-11-01
• First posted: 2005-09-16
• Last updated: 2008-12-19

Locations

31 sites across 7 countries: France, Germany, Italy, Poland, Spain, Sweden, United Kingdom