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Clinical Trials in Japan / NCT06831734
Enrolling by invitation Observational

Post-marketing Surveillance (Special Use-results Surveillance) on Treatment With Alhemo

NCT06831734 · tracked via the Priya Life Science Japan tracker
Sponsor
Novo Nordisk A/S
Phase
Observational
Started
2025-05-02
Last updated
2026-06-15

Condition(s) studied

Haemophilia A, Haemophilia B

Investigational drug(s) / intervention(s)

Concizumab →

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.

Study 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.

Eligibility

Sex
ALL
Min age
12 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: * 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. Exclusion Criteria: * 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). * Mental incapacity, unwillingness or language barriers precluding adequate understanding or cooperation. * A history of hypersensitivity to any ingredients of Alhemo.

Primary outcome measure(s)

  • Number of adverse reaction (AR) — From baseline (week 0) to end of study (week 104)
    Count of adverse reaction.

Trial sites (23)

FacilityCityRegionStatus
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

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06831734 on ClinicalTrials.gov ↗ ← All trials in Japan