Post-marketing Surveillance (Special Use-results Surveillance) on Treatment With Alhemo

Novo Nordisk

Status: Invitation-only

Conditions: Haemophilia A, Haemophilia B

Treatments: Drug: Concizumab

Study type: Observational

Funder types: Industry

Identifiers

NCT06831734

U1111-1286-2960 (Other Identifier)

NN7415-7690

Details and patient eligibility

About

The purpose of the study is to investigate the safety and effectiveness of Alhemo in participants under real-world clinical practice in Japan. Total duration of this study is about 6 years. Participants enrolment will be completed in the first 4 years. The observation period of this study will last for about 2 years for each enrolled participant.

Enrollment: 30 estimated patients

Sex: All

Ages: 12+ years old

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 participant/Legally Acceptable Representative (LAR) and the treating physician before and independently from the decision to include the participant in this study.
• Male or female, age above or equal to 12 years at the time of signing informed consent.
• Diagnosis with Haemophilia A (HA) or Haemophilia B (HB).
• Participant who has never been exposed to concizumab or who starts treatment with concizumab within the past 12 weeks at registration.

Exclusion criteria

• Previous participation in this study. Participation is defined as having given informed consent in this study.
• Treatment with any investigational drug within 30 days prior to baseline (the starting date of Alhemo treatment).
• Mental incapacity, unwillingness or language barriers precluding adequate understanding or cooperation.
• A history of hypersensitivity to any ingredients of Alhemo.

Trial design

30 participants in 1 patient group

Concizumab

Description:

Participants with haemophilia A or haemophilia B without inhibitors will be be treated with commercially available Alhemo according to routine clinical practice at the discretion of the treating physician.

Treatment:

Drug: Concizumab