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

• Conditions: Haemophilia B; Haemophilia A
• Interventions: Drug: Concizumab

• Registration Number: NCT06285071
• Lead Sponsor: Novo Nordisk A/S

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-02-13
• Study First Submitted QC: 2024-02-26
• Study First Posted: 2024-02-29
• Study Start: 2024-08-08
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-09
• Last Update Posted: 2025-04-11
• Primary Completion: 2030-04-30
• Study Completion: 2030-04-30

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 23

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Concizumab	Concizumab	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.

Primary Outcome Measures

Name	Time	Method
Number of adverse reaction (AR)	From baseline (week 0) to end of study (week 104)	Measured as count of ARs.

Secondary Outcome Measures

Name	Time	Method
Number of treated spontaneous and traumatic bleeding episodes	From baseline (week 0) to end of study (week 104)	Measured as count of bleeding episodes.
Number of serious adverse reaction (SAR)	From baseline (week 0) to end of study (week 104)	Measured as count of SARs.
Number of treated spontaneous and traumatic target joint bleeding episodes	From baseline (week 0) to end of study (week 104)	Measured as count of bleeding episodes.
Number of serious adverse event (SAE)	From baseline (week 0) to end of study (week 104)	Measured as count of SAEs.
Number of thromboembolic adverse event (AE)	From baseline (week 0) to end of study (week 104)	Measured as count of thromboembolic AEs.
Number of shock/anaphylaxis AE	From baseline (week 0) to end of study (week 104)	Measured as count of shock/anaphylaxis AEs.
Number of all treatment requiring bleeding episode	From baseline (week 0) to end of study (week 104)	Measured as count of bleeding episodes.

Trial Locations

Locations (7)

Kyushu university hospital_Pediatrics; 🇯🇵 Fukuoka, Japan

Kagoshima City Hospital; 🇯🇵 Kagoshima, Japan

St. Marianna University School of Medicine Hospital_Pediatrics; 🇯🇵 Kanagawa, Japan

Novo Nordisk Investigational Site; 🇯🇵 Toshima, Tokyo, Japan

Mutsu general hospital; 🇯🇵 Aomori, Japan

Sapporo Tokushukai Hospital_Pediatrics; 🇯🇵 Hokkaido, Japan

Tokyo Medical University Hospital; 🇯🇵 Tokyo, Japan