Hemophilia A
Conditions
Brief summary
To assess and describe real-life treatment choices for rFⅧ contained regular prophylaxis/bleeding prevention treatment in pediatric hemophilia patients in China (2007-2013)
Interventions
BIOLOGICALBAY14-2222_Kogenate-FS FVIII
Depends on Doctor's decision
Sponsors
Bayer
Study design
Observational model
CASE_ONLY
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
MALE
Age
2 Years to 18 Years
Healthy volunteers
No
Inclusion criteria
* Male, 2-\<18 years Hemophilia A, based on documented prior testing and/or screening laboratory Patients who had received regular prophylaxis/bleeding prevention treatment, totally/partially with rFⅧ. Regular prophylaxis/bleeding prevention treatment is defined as that proportion of weeks (≥2 infusion/week) of total treatment weeks≥80%\[10\] , and total duration ≥12 weeks. During the regular prophylaxis period, if there were consecutive 4 weeks that \<2 infusion/week, the beginning day of the 4 weeks is defined as the end of regular prophylaxis. Available patient medical data record Written informed consent by parent/legal representative. Consent should be sought from subjects if appropriate
Exclusion criteria
* Patients with measurable inhibitor activity at baseline and history of FVIII inhibitor antibody formation (≥0.6BU by Bethesda assay at two different time points, documentation must be available) Any individuals with another bleeding disease that is different from hemophilia A (e.g, von Willebrand disease, hemophilia B)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Duration of regular prophylaxis | Up to 1.5 years |
| Prophylaxis infusion dose | Up to 1.5 years |
| Percentage of rFVIII usage in prophylaxis | Up to 1.5 years |
Secondary
| Measure | Time frame |
|---|---|
| Bleeding frequency | Up to 1.5 years |
| Quality of life by questionnaire | Up to 1.5 years |
| Joint radiographic score | Up to 1.5 years |
| Joint physical examination score | Up to 1.5 years |
Countries
China
Outcome results
None listed