Development of chronic disease in newly diagnosed Idiopathic Thrombocytopenic Purpura of Childhood. A randomized controlled study on the influence of treatment with intravenous gammaglobulin on the course of the disease.

Phase 3

Completed

Conditions: idiopathic thrombocytopenic purpura
shortness of platelets due to increased destruction
10035534

Registration Number: NL-OMON38126

Lead Sponsor: niversitair Medisch Centrum Utrecht

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 200

Inclusion Criteria

General inclusion criteria
- Children aged 3 months -16 years, presenting to a pediatrician with newly diagnosed acute ITP and
- Platelet count < 20 x 10 9 /L and
- Bleeding tendency < grade 4 (Buchanan) and
- no prior immunomodulating treatment within 4 weeks before diagnosis and
- signed informed consent by parents and/ or patients

Exclusion Criteria

A patient presenting with any of the following criteria will not be included in the study:;General exclusion criteria
- clinical features that are not compatible with the diagnosis of acute ITP, for example: presence of other auto-immune phenomena, organomegaly, other cytopenias besides thrombocytopenia or features susceptible for infectious disease like hepatitis, Epstein-Barr virus or HIV
- immunomodulating treatment (IVIG, corticosteroids) within 4 weeks before diagnosis
- history of allergic reactions against human plasma, plasma products or intravenous immunoglobulin
- Severe or life threatening bleeding at presentation: grade 4 or 5 (Buchanan)
- No informed consent

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Primary outcome of the study is development of chronic disease, defined by<br /><br>platelet count < 150 x10^9/L after six months. </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>- clinical parameters: bleeding tendency, time to recovery of platelet count<br /><br>- quality of life of patients with ITP<br /><br>- laboratory studies: genetic polymorphisms of IgG-Fc receptors and inhibiting<br /><br>immune receptors, auto-antibody profile, glycosylation of auto-antibodies,<br /><br>quantity and function of regulatory T cells. </p><br>