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Post-marketing Surveillance (Special Use-results Surveillance) on Treatment With Alhemo
Sponsor: Novo Nordisk A/S
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.
Official title: 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
Key Details
Gender
All
Age Range
12 Years - Any
Study Type
OBSERVATIONAL
Enrollment
30
Start Date
2025-05-02
Completion Date
2031-01-31
Last Updated
2026-06-15
Healthy Volunteers
Not specified
Conditions
Interventions
Concizumab
Participants will be treated with commercially available Alhemo according to routine clinical practice at the discretion of the treating physician. Administration will be according to the approved product labelling. The decision to treat a participant with Alhemo is made at the physician's discretion before and independently from this study.
Locations (23)
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