ADVATE/ ADYNOVI Hemophilia A Outcome Database (AHEAD)

  • STATUS
    Recruiting
  • End date
    Jan 15, 2025
  • participants needed
    1130
  • sponsor
    Baxalta now part of Shire
Updated on 21 May 2021
Investigator
Takeda Development Center Americas Contact
Primary Contact
CIC (0.5 mi away) Contact
+180 other location
antihemophilic factor
advate

Summary

The purpose of the study is to document the natural history of hemophilia A disease and long-term outcomes in terms of effectiveness, safety and quality of life in participants receiving Antihemophilic Factor (Recombinant) - Plasma/Albumin Free Method (rAHF-PFM) or Antihemophilic Factor (Recombinant) - Pegylated (rAHF-PEG) in routine clinical practice

Details
Condition Hemophilia A, Hemophilia, hema
Treatment Antihemophilic Factor (Recombinant) - Plasma/Albumin Free Method, Advate, ADYNOVI
Clinical Study IdentifierNCT02078427
SponsorBaxalta now part of Shire
Last Modified on21 May 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Participant has hemophilia A {FVIII lesser than or equal to (<=)5%}
Participant is prescribed Antihemophilic Factor (Recombinant) - Plasma/Albumin Free Method (rAHF-PFM) or Antihemophilic Factor (Recombinant) - Pegylated (rAHF-PEG) by the treating physician
Participant or participant's legally authorized representative provides informed consent

Exclusion Criteria

Participant has known hypersensitivity to the active substance or any of the excipients
Participant has known allergic reaction to mouse or hamster proteins
Participant has participated in another clinical study involving an investigational product (IP) or device within 30 days prior to study enrollment or is scheduled to participate in another clinical study involving another FVIII concentrate or device during the course of this study
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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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