NCT06831734Enrolling by invitation
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
Source: ClinicalTrials.gov · Last updated 15 Jun 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Enrolling by invitation
- Study type
- Observational
- Enrollment
- 30 (estimated)
- First submitted
- 12 Feb 2025
- Start date
- 2 May 2025
- Primary completion date
- 31 Jan 2031
- Lead sponsor
- Novo Nordisk A/S
- Diseases
- Haemophilia
- NCT number
- NCT06831734
What you commit to
- Study type: Observational
- Planned participants: 30
- From 2 May 2025 to the primary completion date, 31 Jan 2031
- 23 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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).
Other illness
- A history of hypersensitivity to any ingredients of Alhemo.
Other
- Mental incapacity, unwillingness or language barriers precluding adequate understanding or cooperation.
Who the study is looking for
- 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.
Age in the registry: 12 years to - · Sex: All
Sites (23)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Chiba university hospital_Pediatrics Coordinator of this site? Confirm its status | Chiba | Japan | Unknown status |
| National Hospital Organization Awara Hospital_Hematology and Oncology Coordinator of this site? Confirm its status | Fukui | Japan | Unknown status |
| Hoshi General Hospital_Pediatrics Coordinator of this site? Confirm its status | Fukushima | Japan | Unknown status |
| Hyogo Prefectural Amagasaki General Medical Center_Haematology Coordinator of this site? Confirm its status | Hyōgo | Japan | Unknown status |
| St. Marianna University School of Medicine Hospital_Pediatrics Coordinator of this site? Confirm its status | Kanagawa | Japan | Unknown status |
| Saitama Medical Univ. Hospital Saitama medical center_Department of Transfusion Medicine and Cell Therapy Coordinator of this site? Confirm its status | Kawagoe | Japan | Unknown status |
| Miyagi Children's Hospital_Hematology-Oncology Coordinator of this site? Confirm its status | Miyagi | Japan | Unknown status |
| Nagano Children's Hospital_Hematology-Oncology Coordinator of this site? Confirm its status | Nagano | Japan | Unknown status |
| Nagano red cross hospital_Pediatrics Coordinator of this site? Confirm its status | Nahano | Japan | Unknown status |
| University of the Ryukyus Hospital_Endocrinology and Metabolism, Hematology and Rheumatology Coordinator of this site? Confirm its status | Okinawa | Japan | Unknown status |
| Nanbu Medical Center & Children's Medical Center_Pediatric Hematology Coordinator of this site? Confirm its status | Okinawa | Japan | Unknown status |
| Arin Clinic Shonika_Pediatrics Coordinator of this site? Confirm its status | Okinawa | Japan | Unknown status |
| Kansai Medical University Hospital_Pediatrics Coordinator of this site? Confirm its status | Osaka | Japan | Unknown status |
| Saitama Children's Med Centre_Hematology-Oncology Coordinator of this site? Confirm its status | Saitama | Japan | Unknown status |
| Fukaya Red Cross Hospital_Haematology Coordinator of this site? Confirm its status | Saitama | Japan | Unknown status |
| Saitama Medical Univ. Hospital Saitama medical center_Department of Transfusion Medicine and Cell Therapy Coordinator of this site? Confirm its status | Saitama | Japan | Unknown status |
| Matsue red cross hospital_Pediatrics Coordinator of this site? Confirm its status | Shimane | Japan | Unknown status |
| Iwata City Hospital_Haematology Coordinator of this site? Confirm its status | Shizuoka | Japan | Unknown status |
| Hamamatsu Medical Center_Pediatrics Coordinator of this site? Confirm its status | Shizuoka | Japan | Unknown status |
| National Center for Child Health and Development_Hematology Coordinator of this site? Confirm its status | Tokyo | Japan | Unknown status |
| Ogikubo Hospital_Blood Coagulation Coordinator of this site? Confirm its status | Tokyo | Japan | Unknown status |
| Ishiyama Clinic Coordinator of this site? Confirm its status | Yamagata | Japan | Unknown status |
| St. Marianna Univ., Yokohama City Seibu HP, Pediatrics Dept, Coordinator of this site? Confirm its status | Yokohama-shi, Kanagawa | Japan | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.