Controlled trail of immunoglobulin therapy for patients with idiopathic cardiomyopathy and endomyocardial parvovirus B19 persistence - - a prospective, double-blind, randomized, placebo-controlled clinical trial. - IVIg for PVB19 mediated cardiomyopathy

Phase 1

• Conditions: PVB19 mediated cardiomyopathy; MedDRA version: 9.1Level: LLTClassification code 10056419Term: Dilated cardiomyopathy; MedDRA version: 9.1Level: LLTClassification code 10034099Term: Parvovirus B19 infection

• Registration Number: EUCTR2009-009463-61-NL
• Lead Sponsor: Sanquin Plasma Products

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2009-04-02
• Last Update Posted: 18 June 2018

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

- Symptomatic idiopathic cardiomyopathy >6months.
- Optimal conventional heart failure medication <3 months.
- PVB19 viral load >200 copies/mcg DNA in endomyocardial biopsies (EMBs)

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

- Other causes for heart failure
oSignificant coronary artery disease (lesions >70 % stenosis).
oSignificant valvular disease
oUntreated hypertension (blood pressure >140mmHg)
oSubstance abuse
oChemotherapy induced
- 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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: 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.;Secondary Objective: Analysis of the concentration of Parvo B19 antibodies in the serum of the patients before and after treatment, and in the used Nanogam batches and the association with the change of specific PVB19 subtypes.;Primary end point(s): The main study parameter is the change in cardiac ejection fraction presence of the heart from baseline to endpoint.