The purpose of this study is to assess the safety and effectiveness of Esperoct® for long-term routine use in patients with Haemophilia A. Participants will get Esperoct® as prescribed by their doctor. The study will last for about 2 years for each participant.
Study Type
OBSERVATIONAL
Enrollment
23
Patients will be treated with commercially available Esperoct® according to routine clinical practice at the discretion of the treating physician. The decision to initiate treatment with commercially available Esperoct® has been made by the patient/Legally Acceptable Representative (LAR) and the treating physician before and independently from the decision to include the patient in this study.
Kurume University Hospital, Pediatrics
Fukuoka, Japan
Gifu University Hospital
Gifu, Japan
Number of adverse reactions (ARs) reported during the observation period
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Time frame: From baseline (week 0) to end of study (week 104)
Number of serious adverse events (SAEs) reported during the observation period
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Time frame: From baseline (week 0) to end of study (week 104)
Number of serious adverse reactions (SARs) reported during the observation period
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Time frame: From baseline (week 0) to end of study (week 104)
Number of patients who have confirmed inhibitory antibodies against FVIII during the observation period
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Time frame: From baseline (week 0) to end of study (week 104)
Number of bleeding episodes requiring treatment for patients using Esperoct® during the observation period assessed by annual bleeding rate (ABR)
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Time frame: From baseline (week 0) to end of study (week 104)
Evaluation of the haemostatic response of Esperoct® measured as number of successes for treatment requiring bleeds
Count, assessed based on a four-point scale (excellent, good, moderate and poor) by counting excellent and good as success and moderate and poor as failure
Time frame: From baseline (week 0) to end of study (week 104)
Evaluation of the haemostatic response of Esperoct® measured as number of successes in treatment of bleeds in perioperative management during surgical procedures
Count, assessed as success/failure based on a four-point scale for haemostatic response (excellent, good, moderate and poor) by counting excellent and good as success and moderate and poor as failure
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Saitama Medical University Hospital, Pediatrics
Iruma-gun, Saitama, Japan
University Hospital Kyoto Prefectual University of Medicine
Kamigyo-ku, Kyoto, Japan
St. Marianna University School of Medicine Hospital_Pediatrics
Kanagawa, Japan
St. Marianna University School of Medicine Hospital
Kanagawa, Japan
Nara Medical University Hospital_Pediatrics
Nara, Japan
Nanbu Medical Center & Children's Medical Center
Okinawa, Japan
Shibuya Children's Clinic, Department of Pediatric
Saitama, Japan
Lake Children Clinic
Shiga, Japan
...and 9 more locations
Time frame: From baseline (week 0) to end of study (week 104)