The purpose of the study is to investigate the safety and effectiveness of Alhemo® in all participants under real-world clinical practice in Japan. Participants will get Alhemo® as prescribed by the study doctor. The study will last for about 2 years.
Study Type
OBSERVATIONAL
Enrollment
23
Participants will be treated with commercially available Alhemo (Concizumab) according to routine clinical practice at the discretion of the treating physician. The decision to initiate treatment with commercially available Concizumab 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.
Novo Nordisk Investigational Site
Toshima City, Tokyo, Japan
Mutsu general hospital
Aomori, Japan
Kyushu university hospital_Pediatrics
Fukuoka, Japan
Sapporo Tokushukai Hospital_Pediatrics
Hokkaido, Japan
Number of adverse reaction (AR)
Measured as count of ARs.
Time frame: From baseline (week 0) to end of study (week 104)
Number of serious adverse reaction (SAR)
Measured as count of SARs.
Time frame: From baseline (week 0) to end of study (week 104)
Number of serious adverse event (SAE)
Measured as count of SAEs.
Time frame: From baseline (week 0) to end of study (week 104)
Number of thromboembolic adverse event (AE)
Measured as count of thromboembolic AEs.
Time frame: From baseline (week 0) to end of study (week 104)
Number of shock/anaphylaxis AE
Measured as count of shock/anaphylaxis AEs.
Time frame: From baseline (week 0) to end of study (week 104)
Number of treated spontaneous and traumatic bleeding episodes
Measured as count of bleeding episodes.
Time frame: From baseline (week 0) to end of study (week 104)
Number of treated spontaneous and traumatic target joint bleeding episodes
Measured as count of bleeding episodes.
Time frame: From baseline (week 0) to end of study (week 104)
Number of all treatment requiring bleeding episode
Measured as count of bleeding episodes.
Time frame: From baseline (week 0) to end of study (week 104)
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Kagoshima City Hospital
Kagoshima, Japan
St. Marianna University School of Medicine Hospital_Pediatrics
Kanagawa, Japan
Tokyo Medical University Hospital
Tokyo, Japan