NCT02941783

Drug Use Investigation of Kovaltry in Hemophilia A Patients

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 230 (actual)
• Sponsor: Bayer · Industry
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

Summary

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

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.

Conditions

• Hemophilia A

Interventions

Type	Name	Description
DRUG	Kovaltry (Antihemophilic Factor [Recombinant], BAY81-8973)	Treatment parameters following the physician's decision based on the summary of product characteristics.

Timeline

• Start date: 2016-11-30
• Primary completion: 2022-03-23
• Completion: 2025-09-16
• First posted: 2016-10-21
• Last updated: 2025-10-23

Locations

1 site across 1 country: Japan