Prophylaxis Versus on Demand Treatment for Children With Hemophilia A
|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.
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|