A Post Marketing Surveillance Study for ADYNOVATE in South Korea

  • STATUS
    Recruiting
  • End date
    Dec 31, 2023
  • participants needed
    600
  • sponsor
    Shire
Updated on 3 February 2022
hemostatic
adynovate

Summary

The purpose of this study is to characterize the safety and describe hemostatic effectiveness in patients receiving ADYNOVATE in routine clinical practice.

Details
Condition Hemophilia A
Treatment ADYNOVATE
Clinical Study IdentifierNCT03824522
SponsorShire
Last Modified on3 February 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Participants with a diagnosis of hemophilia A who have been prescribed ADYNOVATE according
to the investigator's judgment shall be included in this study if
The participant or legally authorized representative has given written informed
consent to participate in the study
The participant is indicated for treatment according to the ADYNOVATE South Korea
prescribing information (PI)

Exclusion Criteria

Participants should be excluded from this study if
Any of the contraindications included in the PI for ADYNOVATE apply
The participant or legally authorized representative does not wish to participate in
the study
Participant is enrolled in an interventional trial using an investigational product
other than ADYNOVATE
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How to participate?

Step 1 Connect with a study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer to help accelerate the development of new treatments and to get notified about similar trials.

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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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