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

Hemophilia A Clinical Trial

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Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02263066
• Other study ID #: 17653
• Status: Completed
• Phase: N/A
• First received: October 8, 2014
• Last updated: July 16, 2015
• Start date: October 2014
• Est. completion date: July 2015

Study information

• Verified date: July 2015
• Source: Bayer
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Observational

Clinical Trial 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)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 181
• Est. completion date: July 2015
• Est. primary completion date: July 2015
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 2 Years to 18 Years

Eligibility

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 rF?. 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

Observational Model: Case-Only, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Hemophilia A

Intervention

Biological:
• BAY14-2222_Kogenate-FS FVIII
Depends on Doctor's decision

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Bayer

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Duration of regular prophylaxis		Up to 1.5 years	No
Primary	Prophylaxis infusion dose		Up to 1.5 years	No
Primary	Percentage of rFVIII usage in prophylaxis		Up to 1.5 years	No
Secondary	Bleeding frequency		Up to 1.5 years	No
Secondary	Joint radiographic score		Up to 1.5 years	No
Secondary	Joint physical examination score		Up to 1.5 years	No
Secondary	Quality of life by questionnaire		Up to 1.5 years	No

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