Intravenous Immunoglobulin (IVIg) for Parvovirus B19(PVB19) Mediated Cardiomyopathy

• Status: Completed
• Trial end date: 2018-06-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sanquin; Sanquin Plasma Products BV
• Treatments: Antibodies; gamma-Globulins; Immunoglobulins; Immunoglobulins, Intravenous; Plasma Substitutes; Rho(D) Immune Globulin

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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