Drug Use Investigation of Kovaltry in Hemophilia A Patients

Active, not recruiting

• Conditions: Hemophilia A
• Interventions: Drug: Kovaltry (Antihemophilic Factor [Recombinant], BAY81-8973)

• Registration Number: NCT02941783
• Lead Sponsor: Bayer

Brief 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.

Study Timeline

• Study First Submitted: 2016-10-20
• Study First Submitted QC: 2016-10-20
• Study First Posted: 2016-10-21
• Study Start: 2016-11-30
• Primary Completion: 2022-03-23
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-16
• Last Update Posted: 2024-12-17
• Study Completion: 2025-09-30

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 231

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.

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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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
BAY81-8973	Kovaltry (Antihemophilic Factor [Recombinant], BAY81-8973)	Hemophilia A patients who require Factor VIII replacement therapy

Primary Outcome Measures

Name	Time	Method
Number of participants with adverse events as measure of safety and tolerability	Up to 2 years
Number of participants with serious adverse events as measure of safety and tolerability	Up to 2 years

Secondary Outcome Measures

Name	Time	Method
Number of annual bleeds	Up to 2 years
Efficacy of controlling of bleeds	Up to 2 years	The efficacy is evaluated by the investigator and given on a four point scale: Excellent, Good, Moderate and Poor.

Trial Locations

Locations (1)

Many Locations; 🇯🇵 Multiple Locations, Japan