A Long-term Study of ADYNOVI/ADYNOVATE in Participants With Haemophilia A
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)
The main aim of this study is to check for long-term side effects from ADYNOVI/ADYNOVATE prophylaxis in participants with haemophilia A when used under standard clinical practice in the real-world clinical setting.
Number of Participants With Adverse Events (AE) and Serious Adverse Events (SAE)
Change From Baseline in Estimated Glomerular Filtration Rate (eGFR) at Specified Time Points
Study Arms / Comparison Groups
Haemophilia A Group
Description: Participants with haemophilia A in the study will receive ADYNOVI/ADYNOVATE prescribed prophylactically by physicians based on their standard clinical practice and in accordance with the national summary of product characteristics (SmPC).
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
July 9, 2020
February 28, 2030
Primary Completion Date
February 28, 2030
Inclusion Criteria - 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 factor VIII (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.
N/A - N/A
Accepts Healthy Volunteers
Study Director, +1 866 842 5335, [email protected]
Baxalta now part of Shire
Study Director, Study Director, Shire