Drug Use Investigation of Kovaltry in Hemophilia A Patients
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|ClinicalTrials.gov Identifier: NCT02941783|
Recruitment Status : Active, not recruiting
First Posted : October 21, 2016
Last Update Posted : May 30, 2023
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|Condition or disease||Intervention/treatment|
|Hemophilia A||Drug: Kovaltry (Antihemophilic Factor [Recombinant], BAY81-8973)|
|Study Type :||Observational|
|Actual Enrollment :||231 participants|
|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|
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.
- Number of participants with adverse events as measure of safety and tolerability [ Time Frame: Up to 2 years ]
- Number of participants with serious adverse events as measure of safety and tolerability [ Time Frame: Up to 2 years ]
- Number of annual bleeds [ Time Frame: Up to 2 years ]
- 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.
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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|
- Male and female hemophilia A patients.
- Patients for whom the decision to treat with Kovaltry was determined prior to enrollment in the study.
- 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
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
|Multiple Locations, Japan|
|Study Director:||Bayer Study Director||Bayer|
|Other Study ID Numbers:||
2015/01011 ( Other Identifier: Company Internal )
|First Posted:||October 21, 2016 Key Record Dates|
|Last Update Posted:||May 30, 2023|
|Last Verified:||May 2023|
Blood Coagulation Disorders, Inherited
Blood Coagulation Disorders
Coagulation Protein Disorders
Genetic Diseases, Inborn