Study Completed

Hemophilia A

Bayer Identifier:

17653

ClinicalTrials.gov Identifier:

NCT02263066

EudraCT Number:

Not Available

EU CT Number:

Not Available

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

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)

Key Participants Requirements

Sex

Male

Age

2 - 18 Years

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

October 2014 - July 2015

Phase

N/A

Could I Receive a placebo

Products

Kogenate FS (Recombinant Factor VIII, BAY14-2222)

Accepts Healthy Volunteer

Where to participate

Status	Institution	Location
Completed		Many Locations, China

Primary Outcome

Duration of regular prophylaxis
Time Frame:
Up to 1.5 years
Safety Issue:
No
Prophylaxis infusion dose
Time Frame:
Up to 1.5 years
Safety Issue:
No
Percentage of rFVIII usage in prophylaxis
Time Frame:
Up to 1.5 years
Safety Issue:
No

Secondary Outcome

Bleeding frequency
Time Frame:
Up to 1.5 years
Safety Issue:
No
Joint radiographic score
Time Frame:
Up to 1.5 years
Safety Issue:
No
Joint physical examination score
Time Frame:
Up to 1.5 years
Safety Issue:
No
Quality of life by questionnaire
Time Frame:
Up to 1.5 years
Safety Issue:
No

Trial design

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

Trial Type

Observational

Intervention Type

Biological/Vaccine

Trial Purpose

N/A

Allocation

N/A

Blinding

N/A

Assignment

N/A

Trial Arms

N/A

Additional Information

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