NCT06285071

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

A Multi-centre, Open-label, Single-arm, Non-interventional Post-marketing Study to Investigate Safety and Clinical Parameters of Alhemo® Under Routine Clinical Practice in Japan

• Status: Enrolling By Invitation
• Phase: —
• Study type: Observational
• Enrollment: 23 (estimated)
• Sponsor: Novo Nordisk A/S · Industry
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Haemophilia A
• Haemophilia B

Interventions

Type	Name	Description
DRUG	Concizumab	Participants will be treated with commercially available Alhemo (Concizumab) according to routine clinical practice at the discretion of the treating physician. The decision to initiate treatment with commercially available Concizumab 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.

Timeline

• Start date: 2024-08-08
• Primary completion: 2030-04-30
• Completion: 2030-04-30
• First posted: 2024-02-29
• Last updated: 2025-08-29

Locations

7 sites across 1 country: Japan