Genetic Determinants of the Outcome of Immune Tolerance Induction therapy in patients with severe haemophilia A and inhibitors

Genetic Determinants of the Outcome of Immune Tolerance Induction therapy in patients with severe haemophilia A and inhibitors - GO ITI Study

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON54650

Enrollment

Registered

2016-05-13

Start date

2016-11-28

Completion date

Unknown

Last updated

2024-04-23

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

Conditions

coagulation disorder Hemophilia

Interventions

None listed

Eligibility

Age

No minimum to 99 Years

Inclusion criteria

Inclusion criteria: 1. Severe haemophilia A, defined as a baseline FVIII activity of

Exclusion criteria

Exclusion criteria: Refused informed consent

Design outcomes

Primary

Measure	Time frame
The genetic determinants under study include copy number variations and single nucleotide polymorphisms in FCGR2A, FCGR2B, FCGR2C, FCGR3A, FCGR3B, F8 genotype, F8 haplotype, SNPs in the IL-10, TNF-a and CTLA-4 genes. The main study outcome is the cumulative incidence of completely successful ITI associated with potential genetic determinants.	—

Secondary

Measure	Time frame
The secundary study outcome is the cumulative incidence of partially successful ITI associated with potential genetic determinants.	—

Countries

Netherlands

Outcome results