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

Completed

• Conditions: Hemophilia A

• Registration Number: NCT02263066
• Lead Sponsor: Bayer

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)

Detailed Description

Not available

Study Timeline

• Study Start: 2014-10
• Study First Submitted: 2014-10-08
• Study First Submitted QC: 2014-10-10
• Study First Posted: 2014-10-13
• Status Verified: 2015-07
• Primary Completion: 2015-07
• Study Completion: 2015-07
• Last Update Submitted: 2015-07-16
• Last Update Posted: 2015-07-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 181

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)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Duration of regular prophylaxis	Up to 1.5 years
Percentage of rFVIII usage in prophylaxis	Up to 1.5 years
Prophylaxis infusion dose	Up to 1.5 years

Secondary Outcome Measures

Name	Time	Method
Quality of life by questionnaire	Up to 1.5 years
Bleeding frequency	Up to 1.5 years
Joint physical examination score	Up to 1.5 years
Joint radiographic score	Up to 1.5 years