check_circleStudy Completed
Hemophilia A
Bayer Identifier:
16287
ClinicalTrials.gov Identifier:
EudraCT Number:
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
MaleAge
2 - 16 YearsTrial summary
Enrollment Goal
30Trial Dates
March 2013 - January 2014Phase
Phase 4Could I Receive a placebo
NoProducts
Kogenate FS (Recombinant Factor VIII, BAY14-2222)Accepts Healthy Volunteer
NoWhere to participate
Status | Institution | Location |
---|---|---|
Completed | Peking Union Medical College Hospital | Beijing, 100730, China |
Completed | Institute of Hematology & Blood Diseases Hospital Chinese Ac | Tianjin, China |
Completed | Beijing Children's Hospital | Beijing, China |
Completed | Union hospital of Tongji Medical College,Huazhong university | Wuhan, 430022, China |
Completed | Nanfang Hospital. | Guangzhou, 510515, China |
Primary Outcome
- Difference of annualized number of all bleeds between on-demand and prophylaxis periodAnnualized bleedings period 1 minus period 2 ITT analysis set.date_rangeTime Frame:Week 1-12 (on-demand treatment) and 13-24 (prophylactic treatment)enhanced_encryptionNoSafety Issue:
Secondary Outcome
- Difference of annualized number of joint bleeds between on-demand and prophylaxis periodAnnualized 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_encryptionNoSafety Issue:
- Difference of intra-individual change of joint function during each period assessed by the Hemophilia Joint Health Score between on-demand and prophylaxis periodHemophilia 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)enhanced_encryptionNoSafety Issue:
Trial design
Trial Type
InterventionalIntervention Type
Biological/VaccineTrial Purpose
TreatmentAllocation
N/ABlinding
Open LabelAssignment
Single Group AssignmentTrial Arms
1Additional Information
Click here and search for drug information provided by the FDA.Click here and search for information on any recalls, market or product safety alerts by the FDA which might have occurred with this product.Click here and search for Bayer product resultsClick here to find information about studies related to Bayer Healthcare products conducted in Europe