Evaluation of Long-term Safety of ADYNOVI/ADYNOVATE (Antihaemophilic Factor [Recombinant] PEGylated Rurioctocog Alfa Pegol) in Patients With Haemophilia A - An ADYNOVI/ADYNOVATE Post-Authorisation Safety Study (PASS)

  • STATUS
    Recruiting
  • End date
    Oct 18, 2028
  • participants needed
    200
  • sponsor
    Baxalta now part of Shire
Updated on 9 September 2021
antihemophilic factor
adynovate

Summary

The main purpose is to evaluate the long-term safety of ADYNOVI/ADYNOVATE prophylaxis in patients with haemophilia A when used under standard clinical practice in the real-world setting.

Details
Condition Hemophilia A, hema, Hemophilia
Treatment ADYNOVI/ADYNOVATE
Clinical Study IdentifierNCT04158934
SponsorBaxalta now part of Shire
Last Modified on9 September 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Participants of any age; except for those in the European Union (EU) must be greater than or equal to (>=) 12 years of age (per the approved EU label)
Signed informed consent obtained from participant and/or legally authorised representative before any study related activities (any procedure related to recording of data according to the protocol)
Participant at any age with haemophilia A prescribed ADYNOVI/ADYNOVATE prophylaxis
Negative FVIII inhibitor test at study entry
Decision to initiate treatment with commercially available ADYNOVI/ADYNOVATE has been made by the participant and/or legally authorised representative and the treating physician before and independently from the decision to include the participant in this study

Exclusion Criteria

Previous participation in this study. Participation is defined as signed informed consent
Known or suspected hypersensitivity to ADYNOVI/ADYNOVATE or related products
Mental incapacity, unwillingness or other barriers precluding adequate understanding or cooperation
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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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