Searching Patterns In the Robustness of Immunological FVIII Tolerance

Searching Patterns In the Robustness of Immunological FVIII Tolerance - SPIRIT

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON57120

Enrollment

150

Registered

2024-09-11

Start date

2024-11-15

Completion date

Unknown

Last updated

2025-09-08

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

Conditions

bleeder's disease Hemophilia

Interventions

None listed

Eligibility

Age

No minimum to 17 Years

Inclusion criteria

Inclusion criteria: Congenital hemophilia A of all severities Using Non-factor therapy Aged under 18 years Written informed consent

Exclusion criteria

Exclusion criteria: Acquired hemophilia A Any other bleeding disorder

Design outcomes

Primary

Measure	Time frame
The main study endpoint are the immunological mechanisms underlying tolerance to FVIII, including presence, titers, subtypes and affinities of FVIII-specific (non)-neutralizing antibodies, FVIII-specific T and B cell responses and immunomodulatory microbial metabolites in the fecal samples (i.e. short chain fatty acids, incl. butyrate and/or tryptophan catabolites).	—

Secondary

Measure	Time frame
N.A.	—

Countries

Netherlands

Outcome results