An observational study in Hemophilia A, sponsored by Bayer. Completed. Per ClinicalTrials.gov, last updated 2026-09-09.
Sponsored by Bayer · Observational
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.
866 studies on the registry are indexed under Hemophilia A; 137 are open to participants now.
This study's enrollment of 230 is above the median of 80 across 314 observational studies indexed under Hemophilia A.
Browse Hemophilia A studies →Bayer is the lead sponsor of 1,643 studies on the registry; 57 are open to participants now.
Of its 209 completed or terminated interventional studies of FDA-regulated products, 129 (62%) have results posted.
Counted across the registry records on this site, refreshed daily.
Male and female hemophilia A patients are registered after the decision for treatment with Kovaltry has been made by the investigator. Both 'on demand' and 'prophylaxis' treatment are included.
Exclusion Criteria:
Hemophilia A patients who require Factor VIII replacement therapy
Drug: Kovaltry (Antihemophilic Factor [Recombinant], BAY81-8973)
Treatment parameters following the physician's decision based on the summary of product characteristics.
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
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
Number of annual bleeds
Time frame: Up to 2 years
No study locations are listed for this record.
This study is completed, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.
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