Brief Title
ADVATE/ ADYNOVI Hemophilia A Outcome Database (AHEAD)
Official Title
ADVATE/ ADYNOVI Hemophilia A Outcome Database
Brief 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
Study Type
Observational
Primary Outcome
Joint Health Outcomes - Assessed by Physical Exam Using Only the Pain, Bleeding, and Physical Exam Parameters of the Gilbert Scale
Secondary Outcome
Annualized Bleed Rate, All Joints
Condition
Hemophilia A
Intervention
ADVATE
Study Arms / Comparison Groups
rAHF-PFM
Description: Participants treated with rAHF-PFM alone
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Biological
Estimated Enrollment
630
Start Date
June 29, 2011
Completion Date
January 15, 2025
Primary Completion Date
January 15, 2025
Eligibility Criteria
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
Gender
All
Ages
N/A - N/A
Accepts Healthy Volunteers
No
Contacts
Study Director, +1 866 842 5335, [email protected]
Location Countries
Australia
Location Countries
Australia
Administrative Informations
NCT ID
NCT02078427
Organization ID
061001
Responsible Party
Sponsor
Study Sponsor
Baxalta now part of Shire
Collaborators
Baxalta Innovations GmbH, now part of Shire
Study Sponsor
Study Director, Study Director, Shire
Verification Date
September 2020