NCT06831734

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

Special Use-results Surveillance on Use of Alhemo in Patients With Haemophilia A or Haemophilia B Without Inhibitors A Multi-centre, Open-label, Non-interventional Post-marketing Study to Investigate the Long-term Safety and Clinical Parameters of Treatment With Alhemo in Patients With Haemophilia A or Haemophilia B Without Inhibitors in Routine Clinical Practice Conditions in Japan

• Status: Enrolling By Invitation
• Phase: —
• Study type: Observational
• Enrollment: 30 (estimated)
• Sponsor: Novo Nordisk A/S · Industry
• Sex: All
• Age: 12 Years
• Healthy volunteers: —

Summary

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.

Conditions

• Haemophilia A, Haemophilia B

Interventions

Type	Name	Description
DRUG	Concizumab	Participants will be treated with commercially available Alhemo according to routine clinical practice at the discretion of the treating physician. Administration will be according to the approved product labelling. The decision to treat a participant with Alhemo is made at the physician's discretion before and independently from this study.

Timeline

• Start date: 2025-05-02
• Primary completion: 2031-01-31
• Completion: 2031-01-31
• First posted: 2025-02-18
• Last updated: 2025-08-29

Locations

9 sites across 1 country: Japan