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Register:	EUCTR
Last refreshed on:	3 September 2018
Main ID:	EUCTR2008-001597-33-NL
Date of registration:	29/05/2008
Prospective Registration:	Yes
Primary sponsor:	University Medical Center Utrecht
Public title:	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
Scientific title:	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
Date of first enrolment:	18/06/2009
Target sample size:	300
Recruitment status:	Not Recruiting
URL:	https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2008-001597-33
Study type:	Interventional clinical trial of medicinal product
Study design:	Controlled: yes Randomised: yes Open: yes Single blind: no Double blind: no Parallel group: yes Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: no Placebo: no Other: yes Other specify the comparator: careful observation without medication
Phase:	Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): no Therapeutic confirmatory - (Phase III): yes Therapeutic use (Phase IV): no

Countries of recruitment
Netherlands

Contacts

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Key inclusion & exclusion criteria

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

Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Acute Idiopathic Thrombocytopenic Purpura (ITP) in children
MedDRA version: 14.1 Level: LLT Classification code 10023095 Term: ITP System Organ Class: 10005329 - Blood and lymphatic system disorders

Intervention(s)

Trade Name: Nanogam
Pharmaceutical Form: Solution for infusion
Other descriptive name: HUMAN NORMAL IMMUNOGLOBULIN
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 50-

Primary Outcome(s)

Secondary Objective: Secondary objectives are:

1. To evaluate the clinical parameters during the course of the disease, eg: bleeding score and time between onset of symptoms and recovery of platelet numbers.

2. Comparing the HRQoL in parents and patients with acute ITP who did and did not have IVIG and in those that do and do not develop chronic ITP.

3. Estimation of variability of biological parameters of the immune system of the patient that are supposed to be involved in the differences in outcome between acute vs. chronic disease as well as between response on IVIG treatment vs. non response. These include: A) the genetic polymorphisms of the activating and inhibiting IgG-Fc receptor and other inhibiting immune receptors. B) Immunoglobulin glycosylation variability within the platelet auto antibodies and its changes during time, as well as the changes due to IVIG treatment. C) Quantity and function of regulatory T cells.

Main Objective: The primary objective is to investigate the hypothesis that early IVIG treatment in children with newly diagnosed acute ITP reduces the risk of development of chronic disease.

Primary end point(s): Primary study endpoint is development of chronic ITP, defined by a platelet count of < 150 x 10^9/l six months after diagnosis.

Secondary Outcome(s)

Secondary ID(s)

20081203

Source(s) of Monetary Support

Secondary Sponsor(s)

Ethics review

Results

Results available:
Date Posted:
Date Completed:
URL:

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