Prospective study on early immune response to factor VIII exposure in previously untreated patients with severe hemophilia A

Completed

• Conditions: Bleeding disorder; Haemophilia A; 10064477

• Registration Number: NL-OMON33198
• Lead Sponsor: Academisch Medisch Centrum

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 6 May 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 20

Inclusion Criteria

Severe hemophilia A (factor VIII:C <2%)
Previously untreated Patient
Minimally treated patient (< 5 exposures to factor VIII concentrate)

Exclusion Criteria

Mild/moderate hemophilia A (factor VIII:C > 2%)
Previously treated patient (>5 exposures to factor VIII concetrate)

Study & Design

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

Primary Outcome Measures

Name	Time	Method
<p>- FVIII-specific memory B-cells.<br /><br>- T-cell characteristics.<br /><br>- Cytokine/interleukin secretion.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>- F VIII genotype<br /><br>- Variation in immune response of certain polymorphisms in IL10, TNFA, CTLA-4<br /><br>and MHC class II genes<br /><br>- Copy number variations of FCGR genes</p><br>