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.
Study Type
OBSERVATIONAL
Enrollment
30
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.
Chiba university hospital_Pediatrics
Chiba, 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
Number of adverse reaction (AR)
Count of adverse reaction.
Time frame: From baseline (week 0) to end of study (week 104)
Number of serious adverse reaction (SAR)
Count of serious adverse reaction.
Time frame: From baseline (week 0) to end of study (week 104)
Number of serious adverse event (SAE)
Count of serious adverse event.
Time frame: From baseline (week 0) to end of study (week 104)
Number of thromboembolic adverse event (AE)
Count of thromboembolic adverse event.
Time frame: From baseline (week 0) to end of study (week 104)
Number of shock/anaphylaxis adverse event (AE)
Count of shock/anaphylaxis adverse event.
Time frame: From baseline (week 0) to end of study (week 104)
Number of treated spontaneous and traumatic bleeding episodes
Count of treated spontaneous and traumatic bleeding episodes.
Time frame: From baseline (week 0) to end of study (week 104)
Number of treated spontaneous and traumatic target joint bleeding episodes
Count of treated spontaneous and traumatic target joint bleeding episodes.
Time frame: From baseline (week 0) to end of study (week 104)
Number of all treatment requiring bleeding episodes
Count of all treatment requiring bleeding episodes.
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Nagano red cross hospital_Pediatrics
Nahano, Japan
Nanbu Medical Center & Children's Medical Center
Okinawa, Japan
Kansai Medical University Hospital_Pediatrics
Osaka, Japan
Saitama Medical Univ. Hospital Saitama medical center_Department of Transfusion Medicine and Cell Therapy
Saitama, Japan
Matsue red cross hospital_Pediatrics
Shimane, Japan
National Center for Child Health and Development_Hematology
Tokyo, Japan
Time frame: From baseline (week 0) to end of study (week 104)