Dynamics of the anti-factor VIII antibody signature duringtreatment with emicizumab

Recruiting

• Conditions: Hereditary factor VIII deficiency; D66

• Registration Number: DRKS00031196
• Lead Sponsor: niversitätsklinikum Frankfurt, Klinik für Kinder- und Jugendmedizin, Klinische und Molekulare Hämostaseologie

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2023-02-06
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

Severe congenital hemophilia A (CHA)
- Treatment with emicizumab irrespective of any other treatment
- Informed consent

Exclusion Criteria

- No therapy with emicizumab
- Immunosuppressive therapy
- HIV-infection with CD4 cells <200/µl

Study & Design

• Study Type: observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1. Rate of FVIII inhibitor and antibody development during three years of emicizumab prophylaxis in inhibitor negative subjects (inhibitor negative patients at study entry)<br>2. Rate of FVIII inhibitor and antibody disappearance during three years of emicizumab prophylaxis in inhibitor positive subjects (inhibitor positive patients at study entry)

Secondary Outcome Measures

Name	Time	Method
1. Influence of concomitant FVIII treatment on the anti-FVIII inhibitor/ antibody dynamics<br>2. Time to negative inhibitor titers<br>3. Treatment of bleeds and response to treatment<br>4. Dynamics of the inhibitor signature during emicizumab treatment