rFVIIIFc (Elocta®) ITI Chart Review in Patients With Haemophilia A

Sobi

Status: Completed

Conditions: Hemophilia A With Inhibitor

Treatments: Other: rFVIIIFc

Study type: Observational

Funder types: Industry; Other

Identifiers

NCT03951103

Sobi.Elocta-004

Details and patient eligibility

About

A chart review study of patients with haemophilia A with inhibitors treated with rFVIIIFc (Elocta®) for immune tolerance induction.

Full description

A multicenter, international, non- interventional, retrospective and prospective medical chart review study. Data will be collected from medical records for patients diagnosed with haemophilia A who have been, or who are currently, treated with rFVIIIFc for ITI . The study will be descriptive in nature and report on baseline characteristics, treatment and outcomes for patients who have been, or who are currently, treated with rFVIIIFc for ITI.

Enrollment: 44 patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients diagnosed with haemophilia A who have been, or who are currently, treated with rFVIIIFc for ITI.
• 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 data collection are undertaken. Assent should be obtained from paediatric patients according to local regulations.

Exclusion criteria

• Current participation in any investigational medicinal product trial.

Trial design

44 participants in 1 patient group

Hemophili A patients

Description:

Patients treated with rFVIIIFc for ITI

Treatment:

Other: rFVIIIFc