Dynamics of the anti-factor VIII antibody signature during treatment with emicizumab

Dynamics of the anti-factor VIII antibody signature during treatment with emicizumab - NAVIGATE

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

DRKS

Registry ID

DRKS00031196

Enrollment

100

Registered

2023-02-06

Start date

2023-04-26

Completion date

Unknown

Last updated

2025-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

D66

Interventions

Group 1: Patients with severe haemophilia A receiving Emicizumab therapy.

Eligibility

Sex/Gender

All

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
1. Rate of FVIII inhibitor and antibody development during three years of emicizumab prophylaxis in inhibitor negative subjects (inhibitor negative patients at study entry) 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

Measure	Time frame
1. Influence of concomitant FVIII treatment on the anti-FVIII inhibitor/ antibody dynamics 2. Time to negative inhibitor titers 3. Treatment of bleeds and response to treatment 4. Dynamics of the inhibitor signature during emicizumab treatment	—

Countries

Germany

Contacts

Public ContactStephan Schultze-Strasser

Universitätsklinikum Frankfurt, Klinik für Kinder- und Jugendmedizin, Klinische und Molekulare Hämostaseologie

Schultze-Strasser@med.uni-frankfurt.de+496963016998

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026