Trial Condition(s):

Hemophilia A

Retrospective study in Chinese pediatric hemophilia A patients with rFⅧ contained regular prophylaxis (ReCARE)

Bayer Identifier:

17653

ClinicalTrials.gov Identifier:

NCT02263066

EudraCT Number:

Not Available

Study Completed

Trial Purpose

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

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 Summary

Enrollment Goal
181
Trial Dates
black-arrow
Phase
N/A
Could I receive a placebo?
No
Products
Kogenate FS (Recombinant Factor VIII, BAY14-2222)
Accepts Healthy Volunteers
No

Where to Participate

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Locations
Status
LocationsStatus
Locations

Investigative Site

Many Locations, China

Status
Completed
 

Trial Design