check_circleStudy Completed

Hemophilia A

Bayer Identifier:

16287

ClinicalTrials.gov Identifier:

NCT01810666

EudraCT Number:

2014-001362-10

EU CT Number:

Not Available
Prophylaxis versus on demand treatment for children with Hemophilia A

Trial purpose

Comparison of the effect of three times a week prophylaxis on all bleeds with on-demand treatment for children with severe Hemophilia A.

Key Participants Requirements

Sex

Male

Age

2 - 16 Years
  • - Male, aged 2-16yrs
    - Severe hemophilia A (<1% FVIII:C [Blood Clotting Factor VIII:C] )
    - Minimum of at least 50 documented ED (exposure day) prior to enrolment
    - No measurable inhibitor activity at baseline and history of FVIII inhibitor antibody formation
    - Parents or legal guardians document, sign, and date informed consent
  • - Another bleeding disease that is different from hemophilia A
    - Known hypersensitivity to the active substance, mouse or hamster protein
    - Thrombocytopenia (platelet count <100 000/mm3) based on previous medical records

Trial summary

Enrollment Goal
30
Trial Dates
March 2013 - January 2014
Phase
Phase 4
Could I Receive a placebo
No
Products
Kogenate FS (Recombinant Factor VIII, BAY14-2222)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Completed
Peking Union Medical College HospitalBeijing, 100730, China
Completed
Institute of Hematology & Blood Diseases Hospital Chinese AcTianjin, China
Completed
Beijing Children's HospitalBeijing, China
Completed
Union hospital of Tongji Medical College,Huazhong universityWuhan, 430022, China
Completed
Nanfang Hospital.Guangzhou, 510515, China

Primary Outcome

  • Difference of annualized number of all bleeds between on-demand and prophylaxis period
    Annualized bleedings period 1 minus period 2 ITT analysis set.
    date_rangeTime Frame:
    Week 1-12 (on-demand treatment) and 13-24 (prophylactic treatment)
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    Safety Issue:
    No

Secondary Outcome

  • Difference of annualized number of joint bleeds between on-demand and prophylaxis period
    Annualized joint bleedings period 1 minus period 2 ITT analysis set.
    date_rangeTime Frame:
    Week 1-12 (on-demand treatment) and 13-24 (prophylactic treatment)
    enhanced_encryption
    Safety Issue:
    No
  • Difference of intra-individual change of joint function during each period assessed by the Hemophilia Joint Health Score between on-demand and prophylaxis period
    Hemophilia Joint Health Score(HJHS) ranges from 0 to 124. Higher values in the HJHS represent worse situation for the subject. 2-sided Hodges Lehmann estimates for median 95% CI HJHS values difference of changes ITT analysis set.
    date_rangeTime Frame:
    From baseline to Week 12 (on-demand treatment) and Week 24 (prophylactic treatment)
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    Safety Issue:
    No

Trial design

Routine prophylaxis treatment versus On-demand treatment for Children with severe Hemophilia A: comparison of all bleeding events in Chinese Hemophilia patients
Trial Type
Interventional
Intervention Type
Biological/Vaccine
Trial Purpose
Treatment
Allocation
N/A
Blinding
Open Label
Assignment
Single Group Assignment
Trial Arms
1

Additional Information

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