A Study to Evaluate the Real-world Effectiveness and Usage of Alprolix in Patients With Haemophilia B in France (B-SURE)

Sobi

Status: Completed

Conditions: Haemophilia B

Treatments: Drug: Alprolix

Study type: Observational

Funder types: Industry; Other

Identifiers

NCT03655340

Sobi.Alprolix-001

Details and patient eligibility

About

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.

Enrollment: 91 patients

Sex: All

Volunteers: No Healthy Volunteers

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

Trial design

91 participants in 2 patient groups

Prophylactic patients

Description:

Alprolix will be prescribed according to local practice and administered by patients with haemophilia B for prophylactic treatment

Treatment:

Drug: Alprolix

On demand patients

Description:

Alprolix will be prescribed according to local practice and administered by patients with haemophilia B for on-demand treatment

Treatment:

Drug: Alprolix