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Completed

NCT Number: NCT02941783

Drug Use Investigation of Kovaltry in Hemophilia A Patients

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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Key information

Conditions

Hemophilia A Blood Coagulation Disorders Blood Coagulation Disorders, Inherited Coagulation Protein Disorders Congenital, Hereditary, and Neonatal Diseases and Abnormalities Genetic Diseases, Inborn Hematologic Diseases Hemic and Lymphatic Diseases Hemorrhagic Disorders

Sex eligibility

All sexes

Study type

Observational

Primary location

Many Locations

Multiple Locations, Japan

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Drug

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

Primary outcomes

  1. Number of participants with adverse events as measure of safety and tolerability

    Time frame: Up to 2 years

  2. Number of participants with serious adverse events as measure of safety and tolerability

    Time frame: Up to 2 years

Secondary outcomes

  1. Number of annual bleeds

    Time frame: Up to 2 years

  2. Efficacy of controlling of bleeds

    Time frame: Up to 2 years

    The efficacy is evaluated by the investigator and given on a four point scale: Excellent, Good, Moderate and Poor.

Sponsors and collaborators

Lead sponsor

Bayer

Industry

Registry information

Important dates

Study start
2016
Primary completion
2022
Study completion
2025
First posted
Oct 21, 2016
Registry last updated
Oct 23, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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