Genetic Determinants of the Outcome of Immune Tolerance Induction therapy in patients with severe haemophilia A and inhibitors
Recruiting
- Conditions
- coagulation disorderHemophilia10005330
- Registration Number
- NL-OMON54650
- Lead Sponsor
- Academisch Medisch Centrum
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 50
Inclusion Criteria
1. Severe haemophilia A, defined as a baseline FVIII activity of <0.01 IU mL-1.
2. A current or a history of inhibitor development.
3. Received or is currently receiving immune tolerance induction therapy of any
kind.
4. Written informed consent.
Exclusion Criteria
Refused informed consent
Study & Design
- Study Type
- Observational invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>The genetic determinants under study include copy number variations and single<br /><br>nucleotide polymorphisms in FCGR2A, FCGR2B, FCGR2C, FCGR3A, FCGR3B, F8<br /><br>genotype, F8 haplotype, SNPs in the IL-10, TNF-a and CTLA-4 genes.<br /><br>The main study outcome is the cumulative incidence of completely successful ITI<br /><br>associated with potential genetic determinants. </p><br>
- Secondary Outcome Measures
Name Time Method <p>The secundary study outcome is the cumulative incidence of partially successful<br /><br>ITI associated with potential genetic determinants. </p><br>