Brief Title
Prospective, Non-interventional Study to Evaluate the Effectiveness of Elocta Compared to Conventional Factor Products
Official Title
24-month Prospective, Multicentre, Non-interventional Study to Evaluate the Effectiveness of Elocta Compared to Conventional Factor Products in the Prophylactic Treatment of Patients With Haemophilia A (A-SURE)
Brief Summary
The purpose of the study is to evaluate the effectiveness of Elocta compared to conventional factor products in the prophylactic treatment of patients with haemophilia A over a 24-month prospective period. Data will also be collected for a 12 month retrospective period.
Study Type
Observational
Primary Outcome
Annualised bleeding rate (ABR)
Condition
Hemophilia A
Intervention
efmoroctocog alfa
Study Arms / Comparison Groups
Elocta
Description: Elocta will be prescribed and administered for prophylactic treatment of patients with haemophilia A according to usual clinical practice
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
Drug
Estimated Enrollment
358
Start Date
December 2016
Completion Date
October 2021
Primary Completion Date
October 2021
Eligibility Criteria
Inclusion Criteria: - Male patients with a diagnosis of haemophilia A - Received prophylactic treatment with a factor product for management of haemophilia A in the 12 months prior to enrolment - At enrolment prescribed prophylactic treatment with Elocta or conventional factor product regardless of participation in the study - Having at least 12 months documented pre-study treatment data regarding prophylactic treatment prescriptions and bleeding episodes prior to the baseline visit - Signed and dated informed consent provided by the patient or the patient's legally acceptable representative for patients under the legal age before any study-related activities are undertaken. Assent should be obtained from paediatric patients according to local regulations Exclusion Criteria: - Enrolment in a concurrent clinical interventional study involving intake of an investigational medicinal product (IMP), within 1 year prior to enrolment - Previously treated with commercially available extended half-life products other than Elocta - Presence of factor VIII inhibitors (≥0.60 Bethesda Unit [BU]/mL ) at the latest available inhibitor test using the Nijmegen modified Bethesda assay
Gender
Male
Ages
N/A - N/A
Accepts Healthy Volunteers
No
Contacts
Stefan Lethagen, MD, ,
Location Countries
Austria
Location Countries
Austria
Administrative Informations
NCT ID
NCT02976753
Organization ID
Sobi.Elocta-002
Responsible Party
Sponsor
Study Sponsor
Swedish Orphan Biovitrum
Collaborators
ICON plc
Study Sponsor
Stefan Lethagen, MD, Study Director, Sweden Orphan Biovitrum
Verification Date
November 2020