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

Sobi

Status: Completed

Conditions: Haemophilia B; Haemophilia A

Treatments: Drug: ELOCTA; Drug: ALPROLIX

Study type: Observational

Funder types: Industry

Identifiers

NCT03055611

Sobi.HAEM89-002

Details and patient eligibility

About

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.

Enrollment: 201 patients

Sex: All

Volunteers: No Healthy Volunteers

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.

Trial design

201 participants in 2 patient groups

Haemophilia A patients

Description:

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

Treatment:

Drug: ELOCTA

Haemophilia B patients

Description:

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

Treatment:

Drug: ALPROLIX