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

Not yet recruiting

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

• Registration Number: NCT06831734
• Lead Sponsor: Novo Nordisk A/S

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2025-02-12
• Study First Submitted QC: 2025-02-12
• Study First Posted: 2025-02-18
• Study Start: 2025-03-31
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-09
• Last Update Posted: 2025-04-11
• Primary Completion: 2031-01-31
• Study Completion: 2031-01-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 30

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Concizumab	Concizumab	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.

Primary Outcome Measures

Name	Time	Method
Number of adverse reaction (AR)	From baseline (week 0) to end of study (week 104)	Count of adverse reaction.

Secondary Outcome Measures

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

Trial Locations

Locations (5)

Chiba university hospital_Pediatrics; 🇯🇵 Chiba, Japan

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

Nanbu Medical Center & Children's Medical Center; 🇯🇵 Okinawa, Japan

Saitama Medical Univ. Hospital Saitama medical center_Department of Transfusion Medicine and Cell Therapy; 🇯🇵 Saitama, Japan

National Center for Child Health and Development_Hematology; 🇯🇵 Tokyo, Japan