Following Longitudinally the Outcome of nonsevere hemophilia A patients that are treated With FVIII concentrates for bleeding or surgery.

Recruiting

• Conditions: factor VIII deficiency; nonsevere hemophilia A; 10005330

• Registration Number: NL-OMON46704
• Lead Sponsor: Academisch Medisch Centrum

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: 75

Inclusion Criteria

Nonsevere Hemophilia A patient or Hemophilia A carrier
Need for FVIII treatment for bleeding or surgery

Exclusion Criteria

Use of immunosuppressive medication
Presence of immunological disease
Presence of FVIII inhibitors

Study & Design

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

Primary Outcome Measures

Name	Time	Method
<p>The primary outcome is the identification of:<br /><br>1. Markers of an immune system prone for the development of inhibitors. ;<br /><br>2. Markers of systemic inflammation that may indicate risk of an anti-FVIII<br /><br>immune response, before inhibitors occur.<br /><br><br /><br>Determinants that will be assessed are subdivided in following categories: (1)<br /><br>patient specific determinants (F8 gene mutation and other known genomic<br /><br>predictors), (2) treatment specific determinants (reason for treatment,<br /><br>intensity of treatment, occurrence of an infection) and (3) immunological<br /><br>determinants (FVIII specific T and B cell responses, RNA expression profiles<br /><br>and biomarkers).</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Not applicable.</p><br>