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. - The TIKI study : Treatment with or without IVIG in Kids with acute ITP

Phase 1

• Conditions: Acute Idiopathic Thrombocytopenic Purpura (ITP) in children; MedDRA version: 14.1Level: LLTClassification code 10023095Term: ITPSystem Organ Class: 10005329 - Blood and lymphatic system disorders

• Registration Number: EUCTR2008-001597-33-NL
• Lead Sponsor: niversity Medical Center Utrecht

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2008-05-29
• Last Update Posted: 3 September 2018

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 300

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

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

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 clinical trial of medicinal product
• Study Design: Not specified