Hemophilia A Clinical Trial
Official title:
Comparison of Different Prophylaxis Regimens for Moderate to Severe Hemophilia A Pediatric Patients
Title: Comparison of different prophylaxis regimens for hemophilia A pediatric patients
Principal Investigator: Assistant Professor Darintr Sosothikul, MD Research Question: Does
different factor VIII dosage effect outcome of hemophilia treatment in term of breakthrough
bleeding, number of hospital stay and day-off from school? Type Research: Clinical research
Study design: Single center clinical trials
Concise methodology:
1. Study Population: Children with hemophilia A who received treatment at KCMH from May
2015 to March 2016 will be enrolled in this study. The consent will be obtained before
the study.
2. Observation and measurement:
1. History, interesting clinical data and laboratory data will be recorded in
Clinical record Form (CRF)
2. Measurement:
i. Complete blood count (CBC), Factor VIII level, Factor VIII inhibitor level ii.
Number of breakthrough bleedings, number of hospital stay and day-off from school iii.
Joint score from Hemophilia Joint Health Score 2.1 iv. EQ-5D-5L quality of life
assessment score
3. Data analysis: The p-value of less than 0.05 will be considered statistically
significant. Mann-Whitney test will be used to test correlation of these variables
(CBC, Factor VIII level, Factor VIII inhibitor level, Number of breakthrough bleedings,
number of hospital stay, day-off from school, Hemophilia Joint Health Score 2.1,
EQ-5D-5L quality of life assessment score) Sample size: 16 patients
Potential impacts:
The outcomes of different factor VIII concentrate dose between 15-20 U/kg/dose 2 times/week
and 35-40 U/kg/dose 1 time/week will be revealed. These outcomes include number of
breakthrough bleeding, number of hospital stay, day-off from school, joint health and
quality of life. The result of this study will guide further study on optimal dose and
duration of factor VIII treatment of hemophilia A patients in the future.
n/a
Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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