Trial Condition(s):
Retrospective study in Chinese pediatric hemophilia A patients with rFⅧ contained regular prophylaxis (ReCARE)
17653
Not Available
Not Available
To assess and describe real-life treatment choices for rFⅧ contained regular prophylaxis/bleeding prevention treatment in pediatric hemophilia patients in China (2007-2013)
- 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
- 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)
Locations | Status | |
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Locations Investigative Site Many Locations, China | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Retrospective study in Chinese pediatric hemophilia A patients with rFⅧ contained regular prophylaxis
Trial Type:
Observational
Intervention Type:
Biological/Vaccine
Trial Purpose:
N/A
Allocation:
N/A
Blinding:
N/A
Assignment:
N/A
Trial Arms:
1