Status:

COMPLETED

Post Marketing Surveillance Study for ADYNOVATE in South Korea

Lead Sponsor:

Takeda

Collaborating Sponsors:

Takeda Pharma Korea Co. Ltd.

Conditions:

Hemophilia A

Eligibility:

All Genders

Brief Summary

The main aim of this study is to check for side effects and medical problems in participants with hemophilia A who are receiving ADYNOVATE in routine clinical practice. Also, it will be checked how ef...

Eligibility Criteria

Inclusion

  • Inclusion Criteria
  • Participants with a diagnosis of hemophilia A who will be newly prescribed with ADYNOVATE or already have been prescribed ADYNOVATE according to the study physician'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:
  • The participant or legally authorized representative does not wish to participate in the study.
  • Any of the contraindications included in the PI for ADYNOVATE apply.
  • Participant is enrolled in an interventional trial using an investigational product other than ADYNOVATE.

Exclusion

    Key Trial Info

    Start Date :

    February 25 2019

    Trial Type :

    OBSERVATIONAL

    Allocation :

    ACTUAL

    End Date :

    January 5 2024

    Estimated Enrollment :

    341 Patients enrolled

    Trial Details

    Trial ID

    NCT03824522

    Start Date

    February 25 2019

    End Date

    January 5 2024

    Last Update

    February 26 2024

    Active Locations (8)

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    Page 1 of 2 (8 locations)

    1

    Kyungpook National University Chilgok Hospital

    Daegu, South Korea, 41404

    2

    Kyungpook National University Hospital

    Daegu, South Korea, 41944

    3

    Daegu Catholic University Medical Center

    Daegu, South Korea, 42472

    4

    Severance Hospital Yonsei University Health System

    Seoul, South Korea, 03722