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
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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) |
Primary Purpose: | Treatment |
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 |

Arm | Intervention/treatment |
---|---|
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.

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Ages Eligible for Study: | 2 Years to 16 Years (Child) |
Sexes Eligible for Study: | Male |
Accepts Healthy Volunteers: | No |
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

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
China, Guangdong | |
Guangzhou, Guangdong, China, 510515 | |
China, Hubei | |
Wuhan, Hubei, China, 430022 | |
China | |
Beijing, China, 100730 | |
Beijing, China | |
Tianjin, China |
Study Director: | Bayer Study Director | Bayer |
Additional Information:


Responsible Party: | Bayer |
ClinicalTrials.gov Identifier: | NCT01810666 History of Changes |
Other Study ID Numbers: |
16287 2014-001362-10 ( EudraCT Number ) |
First Posted: | March 13, 2013 Key Record Dates |
Results First Posted: | January 5, 2015 |
Last Update Posted: | May 19, 2015 |
Last Verified: | April 2015 |
Hemophilia A Blood Coagulation Disorders, Inherited Blood Coagulation Disorders Hematologic Diseases Coagulation Protein Disorders |
Hemorrhagic Disorders Genetic Diseases, Inborn Factor VIII Coagulants |