Immune tolerance induction (ITI) in patients with hemophilia A: <br>pathophysiologic mechanisms and difference in efficacy between various types of factor VIII (FVIII) products

Completed

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

• Registration Number: NL-OMON49249
• Lead Sponsor: niversitair Medisch Centrum Utrecht

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 28 February 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 45

Inclusion Criteria

- Age: 6 years and older
- Previously confirmed Hemophilia A
- Previously and frequently (> 50 ED) treated with factor VIII
- Willing and be able to understand the study information and sign the informed consent form;Different subgroups:
* 10 adults with an inhibitor (5 patients with mild or moderate hemophilia A, 5 patients with severe hemophilia A)
* 10 adults without an inhibitor after successful ITI
* 20 patients (10 adults, 10 children age > 6 years) without an inhibitor and without a history of ITI

Exclusion Criteria

- Documented history of persisting severe anaemia (defined as haemoglobin <6.0 mmol/L for men and women)
- Other haematologic or immunologic comorbidity
- Recent (< 3 months) or actual use of immunosuppressive drugs (< 9 months for rituximab, < 3 months for other immunosuppressive drugs)
- Active infection at the moment of blood withdrawal

Study & Design

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