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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

181 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-10-31

Study Completion Date

2015-07-31

Brief Summary

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

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Detailed Description

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Conditions

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Hemophilia A

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

RETROSPECTIVE

Study Groups

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Group 1

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

BAY14-2222_Kogenate-FS FVIII

Intervention Type BIOLOGICAL

Depends on Doctor's decision

Interventions

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BAY14-2222_Kogenate-FS FVIII

Depends on Doctor's decision

Intervention Type BIOLOGICAL

Eligibility Criteria

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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)

Minimum Eligible Age

2 Years

Maximum Eligible Age

18 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No