PROFIT: PRospective studie OF Immune Tolerance induction (ITI)

Recruiting

• Conditions: bleeding disorder; coagulation disorder; 10064477; 10005330

• Registration Number: NL-OMON48806
• Lead Sponsor: niversitair Medisch Centrum Utrecht

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 15 April 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: Not specified
• Target Recruitment: 18

Inclusion Criteria

1. Diagnosis of severe haemophilia A OR haemophilia B. ;AND
2A) Previously Untreated Patient (PUP, < 5 exposure days (EDs))
OR
2B) Treatment with ITI due to presence of inhibitor, whereby ITI is defined as the administration of factor VIII or factor IX concentrate according to the local protocol with the aim of inducing tolerance ;AND
3. Willing and be able to understand the study information and sign the informed consent form. In case of minor patients, this will be done by a proxy.

Exclusion Criteria

- Documented auto-immune disease

Study & Design

• Study Type: Observational non invasive
• Study Design: Not specified