Myocardial DiseasesPhase 3NCT00892112
Intravenous Immunoglobulin (IVIg) for Parvovirus B19(PVB19) Mediated Cardiomyopathy
A Phase 3 study testing Intravenous Immunoglobulins and plasma volume expander in people with Myocardial Diseases and Parvovirus B19, Human, run by Prothya Biosolutions at 1 site in Netherlands.
Trial summary
A prospective randomized double-blind placebo-controlled trail to investigate the effect of high doses of IVIg on cardiac functional capacity and virus presence in a subgroup of patients with chronic symptomatic ICM and a high PVB19 load in the heart. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Myocardial Diseases, Parvovirus B19, Human
- What is being tested?
- Intravenous Immunoglobulins and plasma volume expander
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteNetherlands
- Study dates
- Nov 2009to Jun 2018
- Phase
- Phase 3
- 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
- Idiopathic cardiomyopathy (LVEF <45%) >6months
- Optimal conventional heart failure medication >3 months.
- PVB19 viral load >200 copies/mcg DNA in endomyocardial biopsies (EMBs).
- Signed informed consent
- Aged between 18 and 75 years
Who cannot join
- Other causes for heart failure
- Significant coronary artery disease (lesions >70 % stenosis)
- Significant valvular disease
- Untreated hypertension (blood pressure >140mmHg)
- Substance abuse
- Chemotherapy induced
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- Significant titer of other cardiotrophic viruses (EV, ADV, HHV6, EBV)
- Pregnancy or lactation
- Systemic diseases such as sarcoidosis, giant cell myocarditis, hemochromatosis, or systemic autoimmune diseases.
- Treatment with any other investigational drug within 7 days before study entry or previous enrolment in this study
- Known with allergic reactions against human plasma or plasma products
- Having an ongoing progressive terminal disease, including HIV infection
- Having renal insufficiency (plasma creatinin >115µmol/L or creatinin clearance <20 ml/min)
- Having an ongoing active disease causing general symptoms e.g. chronic active hepatitis, persistent enterovirus infection with ongoing systemic complaints
- Having detectable anti-IgA antibodies
- Active SLE
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Immunoglobulin Therapy for Patients With Idiopathic Cardiomyopathy and Endomyocardial Parvovirus B19 Persistence - a Prospective, Double-blind, Randomized, Placebo-controlled Clinical Trial
A prospective randomized double-blind placebo-controlled trail to investigate the effect of high doses of IVIg on cardiac functional capacity and virus presence in a subgroup of patients with chronic symptomatic ICM and a high PVB19 load in the heart.
Read the detailed description
Rationale: Parvovirus B19 (PVB19) persistence in the heart has been associated with progressive cardiac dysfunction and evolution to idiopathic cardiomyopathy.
Objective: A controlled trial to investigate whether high dose of intravenous immunoglobulin (IVIg) in addition to conventional heart failure therapy in patients with idiopathic cardiomyopathy and PVB19 persistence in the heart achieves improvement of cardiac function in conjunction with virus elimination.
Study design: All patients will undergo routine diagnostic work-up (including physical examination, coronary angiogram, transthoracic echocardiogram, blood studies and endomyocardial biopsies (EMB)), treatment and follow-up for their heart failure. Patients will be randomized to either receive IVIg or placebo on top of their standard heart failure regimen.
- Conditions
- Myocardial Diseases, Parvovirus B19, Human
- Being tested
- Intravenous Immunoglobulins, plasma volume expander
- Keywords
- Immunoglobulins, Intravenous, Cardiomyopathies, Parvo B19, Human
- Medical subject headings
- Cardiomyopathies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intravenous ImmunoglobulinsDrug
Also called Nanogam
2 gr/kg body weight of intravenous immunoglobulin product Nanogam® administered as 0.5 gr/kg IV over a period of 6 hours on each of 4 consecutive days
plasma volume expanderDrug
Also called G.P.O. ("Gepasteuriseerde Plasma-eiwit Oplossing"), Albuman 40 g/l
10 ml/kg BW will be administrated on four consecutive days.
| Study group | Role | What they receive |
|---|---|---|
| intravenous immunoglobulins | Active comparator | IV, 40 ml/kg over 4 days Receives: Drug: Intravenous Immunoglobulins |
| plasma volume expander Albuman | Placebo comparator | IV, 40 ml/kg over 4 days Receives: Drug: plasma volume expander |
What is being measured
The primary outcome is the main question the study is designed to answer.
The main study parameter is the change in cardiac ejection fraction presence of the heart from baseline to endpoint.
Measured: 6 months
Secondary outcomes (1)
Secondary objectives include changes in presence of cardiotrophic viruses, inflammation , fibrosis, cardiac functional capacity, patient quality of life, other echocardiographic parameters.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2009 (estimated)
- Study startNov 2009
- Primary completionJun 2018
- Study completionJun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Myocardial DiseasesStudies of the same condition, open and under way.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Prothya Biosolutions
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- S Heymans, PhD, MD, Principal investigator, AZM, Maastricht
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00892112
- Sponsor's protocol ID
- MD2009.01
- Status last verified
- Aug 2018
- First submitted
- 1 May 2009
- Last updated
- 29 Aug 2018
- Results posted
- No
- Data monitoring committee
- No
Publications
Hazebroek MR, Henkens MTHM, Raafs AG, Verdonschot JAJ, Merken JJ, Dennert RM, Eurlings C, Abdul Hamid MA, Wolffs PFG, Winkens B, Brunner-La Rocca HP, Knackstedt C, van Paassen P, van Empel VPM, Heymans SRB. Intravenous immunoglobulin therapy in adult patients with idiopathic chronic cardiomyopathy and cardiac parvovirus B19 persistence: a prospective, double-blind, randomized, placebo-controlled clinical trial. Eur J Heart Fail. 2021 Feb;23(2):302-309. doi: 10.1002/ejhf.2082. Epub 2021 Jan 7.
PubMed 33347677
Study at a glance
From the registry record, last updated by the sponsor on 29 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immunoglobulin Therapy for Patients With Idiopathic Cardiomyopathy and Endomyocardial Parvovirus B19 Persistence - a Prospective, Double-blind, Randomized, Placebo-controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT00892112
- Acronym / sponsor ID
- MD2009.01
- Conditions
- Myocardial Diseases, Parvovirus B19, Human
- Keywords
- Immunoglobulins, Intravenous, Cardiomyopathies, Parvo B19, Human
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Prothya BiosolutionsIndustry (pharma, biotech, devices)
- Study start
- Nov 2009 (actual)
- Primary completion
- Jun 2018 (actual)
- Study completion
- Jun 2018 (actual)
- First posted
- 4 May 2009 (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.
A prospective randomized double-blind placebo-controlled trail to investigate the effect of high doses of IVIg on cardiac functional capacity and virus presence in a subgroup of patients with chronic symptomatic ICM and a high PVB19 load in the heart.
Detailed description
Rationale: Parvovirus B19 (PVB19) persistence in the heart has been associated with progressive cardiac dysfunction and evolution to idiopathic cardiomyopathy.
Objective: A controlled trial to investigate whether high dose of intravenous immunoglobulin (IVIg) in addition to conventional heart failure therapy in patients with idiopathic cardiomyopathy and PVB19 persistence in the heart achieves improvement of cardiac function in conjunction with virus elimination.
Study design: All patients will undergo routine diagnostic work-up (including physical examination, coronary angiogram, transthoracic echocardiogram, blood studies and endomyocardial biopsies (EMB)), treatment and follow-up for their heart failure. Patients will be randomized to either receive IVIg or placebo on top of their standard heart failure regimen.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| intravenous immunoglobulins | Active comparator | Drug: Intravenous ImmunoglobulinsIV, 40 ml/kg over 4 days |
| plasma volume expander Albuman | Placebo comparator | Drug: plasma volume expanderIV, 40 ml/kg over 4 days |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Idiopathic cardiomyopathy (LVEF <45%) >6months
- Optimal conventional heart failure medication >3 months.
- PVB19 viral load >200 copies/mcg DNA in endomyocardial biopsies (EMBs).
- Signed informed consent
- Aged between 18 and 75 years
Key exclusion criteria (16 listed)
- Other causes for heart failure
- Significant coronary artery disease (lesions >70 % stenosis)
- Significant valvular disease
- Untreated hypertension (blood pressure >140mmHg)
- Substance abuse
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 |
|---|---|---|
| Intravenous ImmunoglobulinsAlso: Nanogam2 gr/kg body weight of intravenous immunoglobulin product Nanogam® administered as 0.5 gr/kg IV over a period of 6 hours on each of 4 consecutive days | Drug | intravenous immunoglobulins |
| plasma volume expanderAlso: G.P.O. ("Gepasteuriseerde Plasma-eiwit Oplossing"), Albuman 40 g/l10 ml/kg BW will be administrated on four consecutive days. | Drug | plasma volume expander Albuman |
Primary outcome
The main study parameter is the change in cardiac ejection fraction presence of the heart from baseline to endpoint.
Time frame: 6 months
1 secondary outcome
Secondary objectives include changes in presence of cardiotrophic viruses, inflammation , fibrosis, cardiac functional capacity, patient quality of life, other echocardiographic parameters.
Time frame: 6 months
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 29 Aug 2018.
- Derived from this study: PubMed 33347677Hazebroek MR, Henkens MTHM, Raafs AG, Verdonschot JAJ, Merken JJ, Dennert RM, Eurlings C, Abdul Hamid MA, Wolffs PFG, Winkens B, Brunner-La Rocca HP, Knackstedt C, van Paassen P, van Empel VPM, Heymans SRB. Intravenous immunoglobulin therapy in adult patients with idiopathic chronic cardiomyopathy and cardiac parvovirus B19 persistence: a prospective, double-blind, randomized, placebo-controlled clinical trial. Eur J Heart Fail. 2021 Feb;23(2):302-309. doi: 10.1002/ejhf.2082. Epub 2021 Jan 7.
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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.
S Heymans, PhD, MD principal investigator
AZM, Maastricht
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Intravenous Immunoglobulins and plasma volume expander in people with Myocardial Diseases and Parvovirus B19, Human, run by Prothya Biosolutions at 1 site in Netherlands.
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 5 inclusion and 16 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 29 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
The main study parameter is the change in cardiac ejection fraction presence of the heart from baseline to endpoint. (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00892112, which also lists 1 linked publication.
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 29 Aug 2018.