Drug Use Investigation of Kovaltry in Hemophilia A Patients

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

230 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-11-30

Study Completion Date

2025-09-16

Brief Summary

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

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Detailed Description

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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

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Hemophilia A

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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BAY81-8973

Hemophilia A patients who require Factor VIII replacement therapy

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

Intervention Type DRUG

Treatment parameters following the physician's decision based on the summary of product characteristics.

Interventions

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

Treatment parameters following the physician's decision based on the summary of product characteristics.

Intervention Type DRUG

Eligibility Criteria

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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

Eligible Sex

ALL

Accepts Healthy Volunteers

No