Post-Marketing Surveillance (All Case Surveillance) on Treatment With Alhemo® in Patients With Haemophilia A or Haemophilia B With Inhibitors

Novo Nordisk

Status: Invitation-only

Conditions: Haemophilia B; Haemophilia A

Treatments: Drug: Concizumab

Study type: Observational

Funder types: Industry

Identifiers

NCT06285071

NN7415-7557

U1111-1274-4740 (Other Identifier)

Details and patient eligibility

About

The purpose of the study is to investigate the safety and effectiveness of Alhemo® in all participants under real-world clinical practice in Japan. Participants will get Alhemo® as prescribed by the study doctor. The study will last for about 2 years.

Enrollment: 23 estimated patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion criteria

• Signed consent obtained before any study-related activities (study-related activities are any procedure related to recording of data according to the protocol)
• The decision to initiate treatment with commercially available Alhemo® has been made by the patient/LAR and the treating physician before and independently from the decision to include the patient in this study
• Male or female patients, regardless of age
• Diagnosis with HAwI/HBwI

Exclusion criteria

- Previous participation in this study. Participation is defined as having given informed consent in this study

Trial design

23 participants in 1 patient group

Concizumab

Description:

Participants with haemophilia A or haemophilia B with inhibitors will be treated with commercially available Alhemo (Concizumab) according to routine clinical practice at the discretion of the treating physician. Recruitment will be completed after 4.5 years from the launch of Concizumab. The observation period for each participant is 2 years. Total duration of this study is about 6.5 years.

Treatment:

Drug: Concizumab