check_circleStudy 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
  • - 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

  • - 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
No
Products
Kogenate FS (Recombinant Factor VIII, BAY14-2222)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Completed
Many Locations, China

Primary Outcome

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

Secondary Outcome

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