Prophylaxis Versus on Demand Treatment for Children With Hemophilia A
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|ClinicalTrials.gov Identifier: NCT01810666|
Recruitment Status : Completed
First Posted : March 13, 2013
Results First Posted : January 5, 2015
Last Update Posted : May 19, 2015
|Condition or disease||Intervention/treatment||Phase|
|Hemophilia A||Biological: Recombinant Factor VIII (Kogenate FS, BAY14-2222)||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||30 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Routine Prophylaxis Treatment Versus On-demand Treatment for Children With Severe Hemophilia A: Comparison of All Bleeding Events in Chinese Hemophilia Patients|
|Study Start Date :||March 2013|
|Actual Primary Completion Date :||January 2014|
|Actual Study Completion Date :||January 2014|
U.S. FDA Resources
|Experimental: Recombinant Factor VIII||
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.
- Difference of Annualized Number of All Bleeds Between On-demand and Prophylaxis Period [ Time Frame: Week 1-12 (on-demand treatment) and 13-24 (prophylactic treatment) ]Annualized bleedings period 1 minus period 2 ITT analysis set.
- Difference of Annualized Number of Joint Bleeds Between On-demand and Prophylaxis Period [ Time Frame: Week 1-12 (on-demand treatment) and 13-24 (prophylactic treatment) ]Annualized joint bleedings period 1 minus period 2 ITT analysis set.
- Difference of Intra-individual Change of Joint Function During Each Period Assessed by the Hemophilia Joint Health Score Between On-demand and Prophylaxis Period [ Time Frame: From baseline to Week 12 (on-demand treatment) and Week 24 (prophylactic treatment) ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01810666
|Guangzhou, Guangdong, China, 510515|
|Wuhan, Hubei, China, 430022|
|Beijing, China, 100730|
|Study Director:||Bayer Study Director||Bayer|