Drug Use Investigation of Kovaltry in Hemophilia A Patients

Special Drug Investigation of Kovaltry in Hemophilia A Patients

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02941783

Acronym

18706

Enrollment

230

Registered

2016-10-21

Start date

2016-11-30

Completion date

2025-09-09

Last updated

2026-09-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hemophilia A

Keywords

Kovaltry, hemophilia A, Japan, Post-marketing surveillance

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.

Interventions

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

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

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

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

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame	Description
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.
Number of annual bleeds	Up to 2 years	—

Contacts

STUDY_DIRECTORBayer Study Director

Bayer

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Sep 10, 2026