Trial Condition(s):
Hemophilia A
Prophylaxis versus on demand treatment for children with Hemophilia A
Bayer Identifier:
16287
ClinicalTrials.gov Identifier:
EudraCT Number:
EU CT Number:
Not Available
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.
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
Trial Summary
Enrollment Goal
Trial Dates
Phase
Could I receive a placebo?
Products
Accepts Healthy Volunteers
Where to Participate
| Locations | |
|---|---|
Locations Peking Union Medical College Hospital Beijing, China, 100730 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Institute of Hematology & Blood Diseases Hospital Chinese Ac Tianjin, China | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Beijing Children's Hospital Beijing, China | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Union hospital of Tongji Medical College,Huazhong university Wuhan, China, 430022 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Nanfang Hospital. Guangzhou, China, 510515 | Contact Us: E-mail: [email protected] Phone: Not Available |
Trial Design
Routine prophylaxis treatment versus On-demand treatment for Children with severe Hemophilia A: comparison of all bleeding events in Chinese Hemophilia patients
Trial Type:
Interventional
Intervention Type:
Biological/Vaccine
Trial Purpose:
Treatment
Allocation:
N/A
Blinding:
Open Label
Assignment:
Single Group Assignment
Trial Arms:
1
Primary Outcome
- Difference of annualized number of all bleeds between on-demand and prophylaxis periodAnnualized bleedings period 1 minus period 2 ITT analysis set.Timeframe: Week 1-12 (on-demand treatment) and 13-24 (prophylactic treatment)
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.Timeframe: 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 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.Timeframe: From baseline to Week 12 (on-demand treatment) and Week 24 (prophylactic treatment)
Additional Information
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