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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.

Register:	ClinicalTrials.gov
Last refreshed on:	6 November 2023
Main ID:	NCT02979119
Date of registration:	21/10/2014
Prospective Registration:	No
Primary sponsor:	PedNet Haemophilia Research Foundation
Public title:	The European Paediatric Network for Haemophilia Management ( PedNet Registry) PedNet
Scientific title:	The European Paediatric Network for Haemophilia Management and the PedNet Haemophilia Registry
Date of first enrolment:	June 2014
Target sample size:	4000
Recruitment status:	Recruiting
URL:	https://clinicaltrials.gov/ct2/show/NCT02979119
Study type:	Observational [Patient Registry]
Study design:
Phase:

Countries of recruitment
Austria	Belgium	Canada	Czechia	Denmark	Finland	France	Germany
Greece	Ireland	Israel	Italy	Netherlands	Norway	Portugal	Spain
Sweden	Switzerland	United Kingdom

Contacts

Name:	Christoph Male, MD
Address:
Telephone:
Email:
Affiliation:	Medical University of Vienna

Name:	Cindy Machielse
Address:
Telephone:	+31850299993
Email:	c.s.machielse@pednet.eu
Affiliation:

Name:	Gili Kenet, PhD, MD
Address:
Telephone:
Email:
Affiliation:	The National Hemophilia Center Ministry of Health Sheba Medical Center Ramat Gan, Israel

Key inclusion & exclusion criteria

Inclusion Criteria:

- Diagnosed with Haemophilia A or B

- Factor VIII/ IX activity of <1 to 25%

- Complete records of Factor treatment and bleeds

- Treated in one of the participating centres

Exclusion Criteria:

- Patients referred because of an inhibitor*

- Informed consent not obtained

Age minimum: N/A
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Factor VIII Deficiency

Factor IX Deficiency

Intervention(s)

Primary Outcome(s)

Number of patients with antibody development to exogenous clotting factors [Time Frame: Until patient reaches age of 18]

Secondary Outcome(s)

Long term outcome different Immune Tolerance Induction (ITI) therapies in patients with inhibitor. [Time Frame: From date first positive inhibitor titer preferably every 3 years until patient reaches age of 18]

Long term outcome of haemophilia on joint status using the Hemophilia Joint Health Score (HJHS) and MRI techniques. [Time Frame: From diagnose every 5 years until patient reaches age of 18]

Secondary ID(s)

Version 6.4 November 2022

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Ethics review

Results

Results available:
Date Posted:
Date Completed:
URL:

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