Status:
COMPLETED
Intravenous Immunoglobulin (IVIg) for Parvovirus B19(PVB19) Mediated Cardiomyopathy
Lead Sponsor:
Prothya Biosolutions
Conditions:
Myocardial Diseases
Parvovirus B19, Human
Eligibility:
All Genders
18-75 years
Phase:
PHASE3
Brief 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 ...
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 invest...
Eligibility Criteria
Inclusion
- 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
Exclusion
- Other causes for heart failure
- Significant coronary artery disease (lesions \>70 % stenosis)
- Significant valvular disease
- Untreated hypertension (blood pressure \>140mmHg)
- Substance abuse
- Chemotherapy induced
- 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
Key Trial Info
Start Date :
November 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2018
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT00892112
Start Date
November 1 2009
End Date
June 1 2018
Last Update
August 29 2018
Active Locations (1)
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1
AZM
Maastricht, Netherlands, 6229 HX