Prospective study on early immune response to factor VIII exposure in previously untreated patients with severe hemophilia A

Prospective study on early immune response to factor VIII exposure in previously untreated patients with severe hemophilia A - PUPS

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON33198

Enrollment

Registered

2009-11-02

Start date

2009-06-16

Completion date

Unknown

Last updated

2024-05-06

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

Conditions

Bleeding disorder Haemophilia A

Interventions

None listed

Eligibility

Age

2 Years to 11 Years

Inclusion criteria

Inclusion criteria: Severe hemophilia A (factor VIII:C

Exclusion criteria

Exclusion criteria: Mild/moderate hemophilia A (factor VIII:C > 2%) Previously treated patient (>5 exposures to factor VIII concetrate)

Design outcomes

Primary

Measure	Time frame
- FVIII-specific memory B-cells. - T-cell characteristics. - Cytokine/interleukin secretion.	—

Secondary

Measure	Time frame
- F VIII genotype - Variation in immune response of certain polymorphisms in IL10, TNFA, CTLA-4 and MHC class II genes - Copy number variations of FCGR genes	—

Countries

Netherlands

Outcome results