Drug Use Investigation of Kovaltry in Hemophilia A Patients

Bayer

Status: Completed

Conditions: Hemophilia A

Treatments: Drug: Kovaltry (Antihemophilic Factor [Recombinant], BAY81-8973)

Study type: Observational

Funder types: Industry

Identifiers

NCT02941783

18706

2015/01011 (Other Identifier)

Details and patient eligibility

About

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

Full 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.

Enrollment: 230 patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion criteria

• Male and female hemophilia A patients.
• Patients for whom the decision to treat with Kovaltry was determined prior to enrollment in the study.

Exclusion criteria

• Patients participating in an investigational program with interventions outside of routine clinical practice.
• Patients with an additional diagnosis of any bleeding/coagulation disorder other than hemophilia A

Trial design

230 participants in 1 patient group

BAY81-8973

Description:

Hemophilia A patients who require Factor VIII replacement therapy

Treatment:

Drug: Kovaltry (Antihemophilic Factor [Recombinant], BAY81-8973)