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NCT01810666 Clinical Trial

Prophylaxis Versus on Demand Treatment for Children With Hemophilia A

Hemophilia A Clinical Trial

Official title:
Routine Prophylaxis Treatment Versus On-demand Treatment for Children With Severe Hemophilia A: Comparison of All Bleeding Events in Chinese Hemophilia Patients

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01810666
Other study ID # 16287
Secondary ID 2014-001362-10
Status Completed
Phase Phase 4
First received March 12, 2013
Last updated April 30, 2015
Start date March 2013
Est. completion date January 2014

Study information
Verified date April 2015
Source Bayer
Contact n/a
Is FDA regulated No
Health authority China: Food and Drug Administration
Study type Interventional

Clinical Trial Summary

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

Recruitment information / eligibility
Status Completed
Enrollment 30
Est. completion date January 2014
Est. primary completion date January 2014
Accepts healthy volunteers No
Gender Male
Age group 2 Years to 16 Years
Eligibility Inclusion Criteria:

- 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

Exclusion Criteria:

- 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

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Biological:
• Recombinant Factor VIII (Kogenate FS, BAY14-2222)
Participants received Recombinant Factor VIII (Rec. factor VIII) on-demand treatment for 12 weeks followed by a 12 weeks prophylaxis treatment phase. The dose and mode of prophylaxis treatment was 25 IU/Kg, 3 times/per week. The dose in on-demand treatment was decided by physician according to the package insert or the current standard of care.

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 Difference of Annualized Number of All Bleeds Between On-demand and Prophylaxis Period Annualized bleedings period 1 minus period 2 ITT analysis set. Week 1-12 (on-demand treatment) and 13-24 (prophylactic treatment) No
Secondary Difference of Annualized Number of Joint Bleeds Between On-demand and Prophylaxis Period Annualized joint bleedings period 1 minus period 2 ITT analysis set. Week 1-12 (on-demand treatment) and 13-24 (prophylactic treatment) No
Secondary 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. From baseline to Week 12 (on-demand treatment) and Week 24 (prophylactic treatment) No
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