Last updated on May 2020

Drug Use Investigation of Kovaltry in Hemophilia A Patients

Brief description of study

The objective in this study is collecting post-marketing information on the safety and efficacy of Kovaltry under the routine clinical practice.

Detailed Study 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.

Clinical Study Identifier: NCT02941783

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