Brief Title
Drug Use Investigation of Kovaltry in Hemophilia A Patients
Official Title
Drug Use Investigation of Kovaltry in Hemophilia A Patients
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 Type
Observational
Primary Outcome
Number of participants with adverse events as measure of safety and tolerability
Secondary Outcome
Number of annual bleeds
Condition
Hemophilia A
Intervention
Kovaltry (Antihemophilic Factor [Recombinant], BAY81-8973)
Study Arms / Comparison Groups
BAY81-8973
Description: Hemophilia A patients who require Factor VIII replacement therapy
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Drug
Estimated Enrollment
30
Start Date
November 30, 2016
Completion Date
November 30, 2021
Primary Completion Date
May 31, 2021
Eligibility 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
Gender
All
Ages
N/A - N/A
Accepts Healthy Volunteers
No
Contacts
Bayer Study Director, (+) 1-888-8422937, [email protected]
Location Countries
Japan
Location Countries
Japan
Administrative Informations
NCT ID
NCT02941783
Organization ID
18706
Secondary IDs
2015/01011
Responsible Party
Sponsor
Study Sponsor
Bayer
Study Sponsor
Bayer Study Director, Study Director, Bayer
Verification Date
February 2021