CardiomyopathiesPhase 2NCT00185250
Betaferon/ Betaseron (Interferon Beta-1b) in Patients With Chronic Viral Cardiomyopathy
A Phase 2 study testing Interferon beta-1b (Betaferon/Betaseron, BAY86-5046) in people with Cardiomyopathies and Heart Diseases, run by Bayer at 31 sites in 7 countries.
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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Cardiomyopathies, Heart Diseases
- What is being tested?
- Interferon beta-1b (Betaferon/Betaseron, BAY86-5046)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 138 participants
- Where
- 31 sitesin 7 countries
- Study dates
- Dec 2002to Nov 2005
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
31 sites in 7 countries.
31 sites in 7 countries
Germany21 sites
Study site
Bad Berka, Thuringia, 99437
Study site
Bad Krozingen, Baden-Wurttemberg, 79189
Study site
Bad Oeynhausen, North Rhine-Westphalia, 32545
Study site
Berlin, State of Berlin, 12200
Study site
Brandenburg an der Havel, Brandenburg, 14770
Study site
Cologne, North Rhine-Westphalia, 50931
Study site
Dortmund, North Rhine-Westphalia, 44137
Study site
Essen, North Rhine-Westphalia, 45147
Study site
Göttingen, Lower Saxony, 37075
Study site
Greifswald, Mecklenburg-Vorpommern, 17489
Study site
Halle, Saxony-Anhalt, 06097
Study site
Hamburg, Free and Hanseatic City of Hamburg, 20251
Study site
Homburg, Saarland, 66421
Study site
Kiel, Schleswig-Holstein, 24105
Study site
Leipzig, Saxony, 04103
Study site
Ludwigshafen am Rhein, Rhineland-Palatinate, 67063
Study site
München, Bavaria, 80636
Study site
Münster, North Rhine-Westphalia, 48149
Study site
Rostock, Mecklenburg-Vorpommern, 18057
Study site
Ulm, Baden-Wurttemberg, 89075
Study site
Wuppertal, North Rhine-Westphalia, 42117
Italy3 sites
Study site
Bergamo, BG, 24128
Study site
Milan, MI, 20132
Study site
Pavia, 27100
About this study
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
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.
Read the 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
- Being tested
- Interferon beta-1b (Betaferon/Betaseron, BAY86-5046), Placebo
- Keywords
- Cardiomyopathy, idiopathic chronic heart failure, Adenovirus, Enterovirus, Parvovirus
- Medical subject headings
- Cardiomyopathies, Heart Diseases, Adenoviridae Infections, Enterovirus Infections, Parvoviridae Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Interferon beta-1b (Betaferon/Betaseron, BAY86-5046)Drug
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)Drug
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
PlaceboDrug
0.25 ml in week 1 and 0.50 ml in weeks 2 to 24 given subcutaneously every other day
PlaceboDrug
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
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | Experimental | Not described Receives: Drug: Interferon beta-1b (Betaferon/Betaseron, BAY86-5046) |
| Arm 2 | Experimental | Not described Receives: Drug: Interferon beta-1b (Betaferon/Betaseron, BAY86-5046) |
| Arm 3 | Placebo comparator | Not described Receives: Drug: Placebo |
| Arm 4 | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Presence of Adenovirus, Enterovirus and/or Parvovirus in endomyocardium
Measured: 12 weeks after the end of a 24 weeks treatment
Secondary outcomes (10)
Changes in NYHA functional class
Measured: 12 weeks and 24 weeks after the end of treatment
Six-minute walking test
Measured: 12 weeks and 24 weeks after the end of treatment
Single clinical symptoms (dyspnea, fatigue, palpitation, atypical angina and angina pectoris)
Measured: 12 weeks and 24 weeks after the end of treatment
Quality of life
Measured: 12 weeks and 24 weeks after the end of treatment
Left ventricular ejection fraction at rest and on exertion
Measured: 12 weeks after the end of treatment
Regional and global wall motion, left ventricular enddiastolic diameter, and left ventricular endsystolic diameter
Measured: 12 weeks after the end of treatment
Inflammatory state in endomyocardial biopsies
Measured: 12 weeks after the end of treatment
Peripheral blood analyses for viral treatment effect and disease markers
Measured: 12 weeks after the end of treatment
Composite clinical endpoint
Measured: 12 weeks and 24 weeks after the end of treatment
Hemodynamics
Measured: 12 weeks after the end of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2005 (estimated)
- Study startDec 2002
- Study completionNov 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CardiomyopathiesStudies of the same condition, open and under way.
- More trials run by BayerThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 138 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bayer
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Bayer Study Director, Study director, Bayer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00185250
- Sponsor's protocol ID
- 91115
- Other IDs
- 305852
- Status last verified
- Dec 2008
- First submitted
- 10 Sep 2005
- Last updated
- 19 Dec 2008
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00185250
- Acronym / sponsor ID
- 91115
- Conditions
- Cardiomyopathies, Heart Diseases
- Keywords
- Cardiomyopathy, idiopathic chronic heart failure, Adenovirus, Enterovirus, Parvovirus
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 138 participants (actual)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Study start
- Dec 2002
- Study completion
- Nov 2005 (actual)
- First posted
- 16 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Arm 1 | Experimental | Drug: Interferon beta-1b (Betaferon/Betaseron, BAY86-5046) |
| Arm 2 | Experimental | Drug: Interferon beta-1b (Betaferon/Betaseron, BAY86-5046) |
| Arm 3 | Placebo comparator | Drug: Placebo |
| Arm 4 | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | Arm 1 |
| 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 | Arm 2 |
| Placebo0.25 ml in week 1 and 0.50 ml in weeks 2 to 24 given subcutaneously every other day | Drug | Arm 3 |
| Placebo0.25 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 | Drug | Arm 4 |
Primary outcome
Presence of Adenovirus, Enterovirus and/or Parvovirus in endomyocardium
Time frame: 12 weeks after the end of a 24 weeks treatment
10 secondary outcomes
Changes in NYHA functional class
Time frame: 12 weeks and 24 weeks after the end of treatment
Six-minute walking test
Time frame: 12 weeks and 24 weeks after the end of treatment
Single clinical symptoms (dyspnea, fatigue, palpitation, atypical angina and angina pectoris)
Time frame: 12 weeks and 24 weeks after the end of treatment
Quality of life
Time frame: 12 weeks and 24 weeks after the end of treatment
Left ventricular ejection fraction at rest and on exertion
Time frame: 12 weeks after the end of treatment
Regional and global wall motion, left ventricular enddiastolic diameter, and left ventricular endsystolic diameter
Time frame: 12 weeks after the end of treatment
Inflammatory state in endomyocardial biopsies
Time frame: 12 weeks after the end of treatment
Peripheral blood analyses for viral treatment effect and disease markers
Time frame: 12 weeks after the end of treatment
Composite clinical endpoint
Time frame: 12 weeks and 24 weeks after the end of treatment
Hemodynamics
Time frame: 12 weeks after the end of treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Dec 2008.
Related trials for Cardiomyopathies
RecruitingObservational study
AI-powered ECG Analysis Using Willem™ Software in High-risk Cardiac Patients (WILLEM)
Cardiomyopathies, Cardiac Arrest
Not yet recruiting
Human Experimental Models of Pain (HEMP)
Acute Pain
Active, not recruitingObservational study
A Retrospective Observational Study of Epidemiology and Outcomes in Transthyretin Amyloid Cardiomyopathy in Germany
ATTR-CM (Transthyretin Amyloid Cardiomyopathy)
Active, not recruiting
Assessment of Combined CCM and ICD Device in HFrEF
Heart Failure, Heart Failure With Reduced Ejection Fraction
Not yet recruiting
NHLBI SESAME (SEptal Scoring Along Midline Endocardium) Multi-Center Prospective Study Using Improvised Off-Label Devices
Hypertrophic Cardiomyopathy, Left Ventricular Outflow Obstruction
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bayer Study Director study director
Bayer
31 sites in 7 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Interferon beta-1b (Betaferon/Betaseron, BAY86-5046) in people with Cardiomyopathies and Heart Diseases, run by Bayer at 31 sites in 7 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Dec 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 31 sites in Germany, Italy, France, Poland, Spain and 2 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Presence of Adenovirus, Enterovirus and/or Parvovirus in endomyocardium (time frame: 12 weeks after the end of a 24 weeks treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Dec 2008.