clinical trial · NCT02941783
Drug Use Investigation of Kovaltry in Hemophilia A Patients
Bayer·—·completed·n = 230
Hemophilia AKovaltry (Antihemophilic Factor [Recombinant], BAY81-8973)
brief summary
The objective in this study is collecting post-marketing information on the safety and efficacy of Kovaltry under the routine clinical practice.
started
Nov 30, 2016
primary completion
Mar 23, 2022
completion
Sep 16, 2025
last updated
Oct 23, 2025
detailed description
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.
sourced from ClinicalTrials.gov · pharmadog mirrors structured fields, not the full protocol