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

NCT00892112 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2018-08-29

No results posted yet for this study

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.

Conditions

  • Myocardial Diseases
  • Parvovirus B19, Human

Interventions

DRUG

Intravenous Immunoglobulins

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

DRUG

plasma volume expander

10 ml/kg BW will be administrated on four consecutive days.

Sponsors & Collaborators

  • Prothya Biosolutions

    lead INDUSTRY

Principal Investigators

  • S Heymans, PhD, MD · AZM, Maastricht

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-11-30
Primary Completion
2018-06-30
Completion
2018-06-30

Countries

  • Netherlands

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00892112 on ClinicalTrials.gov