Brief Title
A Study to Evaluate the Real-world Usage and Effectiveness of Elocta and Alprolix in Patients With Haemophilia A or B
Official Title
A 24-month Prospective, Non-interventional, Multicentre Study to Evaluate the Real-World Usage and Effectiveness of Elocta and Alprolix in Patients With Haemophilia A or B
Brief Summary
Elocta (rFVIIIFc) and Alprolix (rFIXFc) are recombinant extended half-life coagulation factor products. The purpose of this non-interventional study is to describe the real-world usage and effectiveness of Elocta and Alprolix in the prophylactic treatment of haemophilia A and B.
Study Type
Observational
Primary Outcome
Annualised bleeding rate (ABR)
Condition
Haemophilia A
Intervention
ELOCTA
Study Arms / Comparison Groups
Haemophilia A patients
Description: Elocta will be prescribed according to local practice and administered by patients with haemophilia A 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
201
Start Date
May 9, 2017
Completion Date
April 19, 2022
Primary Completion Date
April 19, 2022
Eligibility Criteria
Inclusion Criteria: - Have a diagnosis of haemophilia A or B and previously treated with factor Product - Have started prophylactic Elocta/Alprolix treatment prior to enrollment visit, or at enrollment prescribed prophylactic treatment with Elocta or 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, from four weeks prior to first injection with Elocta or Alprolix to enrollment visit.
Gender
All
Ages
N/A - N/A
Accepts Healthy Volunteers
No
Contacts
Elena Santagostino, MD, ,
Location Countries
Germany
Location Countries
Germany
Administrative Informations
NCT ID
NCT03055611
Organization ID
Sobi.HAEM89-002
Responsible Party
Sponsor
Study Sponsor
Swedish Orphan Biovitrum
Study Sponsor
Elena Santagostino, MD, Study Director, Swedish Orphan Biovitrum
Verification Date
May 2022