Prophylaxis Versus on Demand Treatment for Children With Hemophilia A
Routine Prophylaxis Treatment Versus On-demand Treatment for Children With Severe Hemophilia A: Comparison of All Bleeding Events in Chinese Hemophilia Patients
2 other identifiers
interventional
30
1 country
5
Brief Summary
Comparison of the effect of three times a week prophylaxis on all bleeds with on-demand treatment for children with severe Hemophilia A.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_4
Started Mar 2013
Shorter than P25 for phase_4
5 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2013
CompletedFirst Submitted
Initial submission to the registry
March 12, 2013
CompletedFirst Posted
Study publicly available on registry
March 13, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2014
CompletedResults Posted
Study results publicly available
January 5, 2015
CompletedMay 19, 2015
April 1, 2015
10 months
March 12, 2013
December 22, 2014
April 30, 2015
Conditions
Outcome Measures
Primary Outcomes (1)
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)
Secondary Outcomes (2)
Difference of Annualized Number of Joint Bleeds Between On-demand and Prophylaxis Period
Week 1-12 (on-demand treatment) and 13-24 (prophylactic treatment)
Difference of Intra-individual Change of Joint Function During Each Period Assessed by the Hemophilia Joint Health Score Between On-demand and Prophylaxis Period
From baseline to Week 12 (on-demand treatment) and Week 24 (prophylactic treatment)
Study Arms (1)
Recombinant Factor VIII
EXPERIMENTALInterventions
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Bayerlead
Study Sites (5)
Unknown Facility
Guangzhou, Guangdong, 510515, China
Unknown Facility
Wuhan, Hubei, 430022, China
Unknown Facility
Beijing, 100730, China
Unknown Facility
Beijing, China
Unknown Facility
Tianjin, China
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Therapeutic Area Head
- Organization
- BAYER
Study Officials
- STUDY DIRECTOR
Bayer Study Director
Bayer
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- GT60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 12, 2013
First Posted
March 13, 2013
Study Start
March 1, 2013
Primary Completion
January 1, 2014
Study Completion
January 1, 2014
Last Updated
May 19, 2015
Results First Posted
January 5, 2015
Record last verified: 2015-04