Follows people with haemophilia treated with Alhemo in routine care
Monitors safety of Alhemo in people with haemophilia A or B without inhibitors.
Plain-language title generated from the registry record
Registry title: Post-marketing Surveillance (Special Use-results Surveillance) on Treatment With Alhemo
Key facts
- Where
- Chiba, Fukui, Fukushima, Hyōgo, Kanagawa, Kawagoe, Miyagi, Nagano, Nahano, Okinawa, Osaka, Saitama, Shimane, Shizuoka, Tokyo, Yamagata, and Yokohama-shi, Kanagawa, JapanSee the 23 sites
Where in Japan
- Chiba university hospital_PediatricsChiba, JapanNo longer taking part
- National Hospital Organization Awara Hospital_Hematology and OncologyFukui, JapanNo longer taking part
- Hoshi General Hospital_PediatricsFukushima, JapanNo longer taking part
- Hyogo Prefectural Amagasaki General Medical Center_HaematologyHyōgo, JapanNo longer taking part
- St. Marianna University School of Medicine Hospital_PediatricsKanagawa, JapanNo longer taking part
- Saitama Medical Univ. Hospital Saitama medical center_Department of Transfusion Medicine and Cell TherapyKawagoe, JapanNo longer taking part
- Miyagi Children's Hospital_Hematology-OncologyMiyagi, JapanNo longer taking part
- Nagano Children's Hospital_Hematology-OncologyNagano, JapanNo longer taking part
- Nagano red cross hospital_PediatricsNahano, JapanNo longer taking part
- Arin Clinic Shonika_PediatricsOkinawa, JapanNo longer taking part
- Nanbu Medical Center & Children's Medical Center_Pediatric HematologyOkinawa, JapanNo longer taking part
- University of the Ryukyus Hospital_Endocrinology and Metabolism, Hematology and RheumatologyOkinawa, JapanNo longer taking part
- Kansai Medical University Hospital_PediatricsOsaka, JapanNo longer taking part
- Fukaya Red Cross Hospital_HaematologySaitama, JapanNo longer taking part
- Saitama Children's Med Centre_Hematology-OncologySaitama, JapanNo longer taking part
- Saitama Medical Univ. Hospital Saitama medical center_Department of Transfusion Medicine and Cell TherapySaitama, JapanNo longer taking part
- Matsue red cross hospital_PediatricsShimane, JapanNo longer taking part
- Hamamatsu Medical Center_PediatricsShizuoka, JapanNo longer taking part
- Iwata City Hospital_HaematologyShizuoka, JapanNo longer taking part
- National Center for Child Health and Development_HematologyTokyo, JapanNo longer taking part
- Ogikubo Hospital_Blood CoagulationTokyo, JapanNo longer taking part
- Ishiyama ClinicYamagata, JapanNo longer taking part
- St. Marianna Univ., Yokohama City Seibu HP, Pediatrics Dept,Yokohama-shi, Kanagawa, JapanNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Novo Nordisk A/S
- Trial code
- NCT06831734
- Record updated
- 15 June 2026
- Original description
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.Read full original descriptionShow less
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
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.
Inclusion: 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: 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); A history of hypersensitivity to any ingredients of Alhemo; Mental incapacity, unwillingness or language barriers precluding adequate understanding or cooperation.