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

Enrolling by invitation

Conditions studied: Haemophilia A, Haemophilia B

In brief

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.

Key facts

Study ID

NCT06831734

Run by

Novo Nordisk A/S

People needed

30

Starts

2025-05-02

Expected to finish

2031-01-31

Last updated by the study team

2026-06-15

Who can join

Age: 12 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Chiba university hospital_Pediatrics — Chiba, Japan
• National Hospital Organization Awara Hospital_Hematology and Oncology — Fukui, Japan
• Hoshi General Hospital_Pediatrics — Fukushima, Japan
• Hyogo Prefectural Amagasaki General Medical Center_Haematology — Hyōgo, Japan
• St. Marianna University School of Medicine Hospital_Pediatrics — Kanagawa, Japan
• Saitama Medical Univ. Hospital Saitama medical center_Department of Transfusion Medicine and Cell Therapy — Kawagoe, Japan
• Miyagi Children's Hospital_Hematology-Oncology — Miyagi, Japan
• Nagano Children's Hospital_Hematology-Oncology — Nagano, Japan
• Nagano red cross hospital_Pediatrics — Nahano, Japan
• Nanbu Medical Center & Children's Medical Center_Pediatric Hematology — Okinawa, Japan
• Arin Clinic Shonika_Pediatrics — Okinawa, Japan
• University of the Ryukyus Hospital_Endocrinology and Metabolism, Hematology and Rheumatology — Okinawa, Japan
• Kansai Medical University Hospital_Pediatrics — Osaka, Japan
• Saitama Children's Med Centre_Hematology-Oncology — Saitama, Japan
• Saitama Medical Univ. Hospital Saitama medical center_Department of Transfusion Medicine and Cell Therapy — Saitama, Japan
• Fukaya Red Cross Hospital_Haematology — Saitama, Japan
• Matsue red cross hospital_Pediatrics — Shimane, Japan
• Hamamatsu Medical Center_Pediatrics — Shizuoka, Japan
• Iwata City Hospital_Haematology — Shizuoka, Japan
• National Center for Child Health and Development_Hematology — Tokyo, Japan
• Ogikubo Hospital_Blood Coagulation — Tokyo, Japan
• Ishiyama Clinic — Yamagata, Japan
• St. Marianna Univ., Yokohama City Seibu HP, Pediatrics Dept, — Yokohama-shi, Kanagawa, Japan

Full record on ClinicalTrials.gov

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