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Drug Use Investigation of Kovaltry in Hemophilia A Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02941783
Recruitment Status : Active, not recruiting
First Posted : October 21, 2016
Last Update Posted : May 30, 2023
Sponsor:
Information provided by (Responsible Party):
Bayer

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

Condition or disease Intervention/treatment
Hemophilia A Drug: Kovaltry (Antihemophilic Factor [Recombinant], BAY81-8973)

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 Design
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Study Type : Observational
Actual Enrollment : 231 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Drug Use Investigation of Kovaltry in Hemophilia A Patients
Actual Study Start Date : November 30, 2016
Actual Primary Completion Date : March 23, 2022
Estimated Study Completion Date : March 27, 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hemophilia

Groups and Cohorts
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Group/Cohort Intervention/treatment
BAY81-8973
Hemophilia A patients who require Factor VIII replacement therapy
 Drug: Kovaltry (Antihemophilic Factor [Recombinant], BAY81-8973)
Treatment parameters following the physician's decision based on the summary of product characteristics.


Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  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.


Eligibility Criteria
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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Male and female hemophilia A patients are registered after the decision for treatment with Kovaltry has been made by the investigator. Both 'on demand' and 'prophylaxis' treatment are included.
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02941783


Locations
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Japan
Many Locations
Multiple Locations, Japan
Sponsors and Collaborators
Bayer
Investigators
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Study Director: Bayer Study Director Bayer
More Information
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Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT02941783    
Other Study ID Numbers: 18706
2015/01011 ( Other Identifier: Company Internal )
First Posted: October 21, 2016    Key Record Dates
Last Update Posted: May 30, 2023
Last Verified: May 2023
Keywords provided by Bayer:
Kovaltry
hemophilia A
Japan
Post-marketing surveillance
Additional relevant MeSH terms:
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Hemophilia A
Blood Coagulation Disorders, Inherited
Blood Coagulation Disorders
Hematologic Diseases
Coagulation Protein Disorders
 Hemorrhagic Disorders
Genetic Diseases, Inborn
Factor VIII
Coagulants