Brief Title
A Study to Evaluate the Real-world Effectiveness and Usage of Alprolix in Patients With Haemophilia B in France
Official Title
A 24-month Prospective, Non-interventional, Multicentre Study to Evaluate the Real-world Effectiveness and Usage of Alprolix in Patients With Haemophilia B in France
Brief Summary
Alprolix (rFIXFc) is a recombinant extended half-life coagulation factor product. The purpose of this non-interventional study is to describe the real-world usage and effectiveness of Alprolix in the on-demand and prophylactic treatment of haemophilia B.
Study Type
Observational
Primary Outcome
Annualised bleeding rate (ABR) (prophylactic treatment)
Condition
Haemophilia B
Intervention
Alprolix
Study Arms / Comparison Groups
Prophylactic patients
Description: Alprolix will be prescribed according to local practice and administered by patients with haemophilia B for prophylactic treatment
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
91
Start Date
September 12, 2018
Completion Date
March 16, 2022
Primary Completion Date
March 16, 2022
Eligibility Criteria
Inclusion Criteria: - Have a diagnosis of haemophilia B and been treated previously with factor IX Product - Have started Alprolix treatment prior to enrolment visit, or at enrolment prescribed treatment with Alprolix, regardless of participation in the study - 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: - Participation in an investigational medicinal product trial at enrolment visit
Gender
All
Ages
N/A - N/A
Accepts Healthy Volunteers
No
Contacts
Elena Santagostino, MD, ,
Location Countries
France
Location Countries
France
Administrative Informations
NCT ID
NCT03655340
Organization ID
Sobi.Alprolix-001
Responsible Party
Sponsor
Study Sponsor
Swedish Orphan Biovitrum
Collaborators
Cerner Enviza
Study Sponsor
Elena Santagostino, MD, Study Director, Swedish Orphan Biovitrum
Verification Date
January 2023