Status:
COMPLETED
Retrospective Study in Chinese Pediatric Hemophilia A Patients With rFⅧ Contained Regular Prophylaxis
Lead Sponsor:
Bayer
Conditions:
Hemophilia A
Eligibility:
MALE
2-18 years
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)
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
October 1 2014
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
July 1 2015
Estimated Enrollment :
181 Patients enrolled
Trial Details
Trial ID
NCT02263066
Start Date
October 1 2014
End Date
July 1 2015
Last Update
July 17 2015
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Many Locations, China