The objective in this study is collecting post-marketing information on the safety and efficacy of Kovaltry under the routine clinical practice.
This company-sponsored study is a single-arm, prospective, observational study in hemophilia A patients administered Kovaltry. 200 cases will be planned to be registered as safety analysis set in three-year period. Within 200 cases, 50 cases less than 12 years old will be planned to be registered. Target population are all hemophilia A patients. The treatment should be performed based on the product label in Japan. The standard observation period is two years.
Study Type
OBSERVATIONAL
Enrollment
230
Treatment parameters following the physician's decision based on the summary of product characteristics.
Many Locations
Multiple Locations, Japan
Number of participants with adverse events as measure of safety and tolerability
Time frame: Up to 2 years
Number of participants with serious adverse events as measure of safety and tolerability
Time frame: Up to 2 years
Number of annual bleeds
Time frame: Up to 2 years
Efficacy of controlling of bleeds
The efficacy is evaluated by the investigator and given on a four point scale: Excellent, Good, Moderate and Poor.
Time frame: Up to 2 years
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