Retrospective Study in Chinese Pediatric Hemophilia A Patients With rFⅧ Contained Regular Prophylaxis (ReCARE)

Bayer

Status: Completed

Conditions: Hemophilia A

Treatments: Biological: BAY14-2222_Kogenate-FS FVIII

Study type: Observational

Funder types: Industry

Identifiers

NCT02263066

17653

Details and patient eligibility

About

To assess and describe real-life treatment choices for rFⅧ contained regular prophylaxis/bleeding prevention treatment in pediatric hemophilia patients in China (2007-2013)

Enrollment: 181 patients

Sex: Male

Ages: 2 to 18 years old

Volunteers: No Healthy Volunteers

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)

Trial design

181 participants in 1 patient group

Group 1

Description:

Chinese hemophilia A pediatric patients with medical records who had accepted regular prophylaxis, totally/partially with rFⅧ between Nov. 1st 2007 and May 31st 2013

Treatment:

Biological: BAY14-2222_Kogenate-FS FVIII