Brief Title
Retrospective Study in Chinese Pediatric Hemophilia A Patients With rFⅧ Contained Regular Prophylaxis
Official Title
Retrospective Study in Chinese Pediatric Hemophilia A Patients With rFⅧ Contained Regular Prophylaxis
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)
Study Type
Observational
Primary Outcome
Duration of regular prophylaxis
Secondary Outcome
Bleeding frequency
Condition
Hemophilia A
Intervention
BAY14-2222_Kogenate-FS FVIII
Study Arms / Comparison Groups
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
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Biological
Estimated Enrollment
181
Start Date
October 2014
Completion Date
July 2015
Primary Completion Date
July 2015
Eligibility Criteria
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)
Gender
Male
Ages
2 Years - 18 Years
Accepts Healthy Volunteers
No
Contacts
Bayer Study Director, ,
Location Countries
China
Location Countries
China
Administrative Informations
NCT ID
NCT02263066
Organization ID
17653
Responsible Party
Sponsor
Study Sponsor
Bayer
Study Sponsor
Bayer Study Director, Study Director, Bayer
Verification Date
July 2015