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

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

NCT06831734•Novo Nordisk A/S

View on ClinicalTrials.gov

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

Age

12 - No limit years

Sex

ALL

Healthy Volunteers

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.

Locations (9)

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

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

Key Dates

Start Date

May 2, 2025

Primary Completion Date

January 31, 2031

Completion Date

January 31, 2031

Last Updated

August 29, 2025

Enrollment

ESTIMATED participants

Conditions

Haemophilia A, Haemophilia B

Interventions

Concizumab

DRUG