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ENROLLING_BY_INVITATION

Post-Marketing Surveillance (All Case Surveillance) on Treatment With Alhemo® in Patients With Haemophilia A or Haemophilia B With Inhibitors

A Multi-centre, Open-label, Single-arm, Non-interventional Post-marketing Study to Investigate Safety and Clinical Parameters of Alhemo® Under Routine Clinical Practice in Japan

NCT06285071•Novo Nordisk A/S

View on ClinicalTrials.gov

Summary

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.

Eligibility

Age

All ages

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 patient/LAR and the treating physician before and independently from the decision to include the patient in this study
•Male or female patients, regardless of age
•Diagnosis with HAwI/HBwI

Exclusion Criteria

•\- Previous participation in this study. Participation is defined as having given informed consent in this study

Locations (7)

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

Kagoshima City Hospital

Kagoshima, Japan

St. Marianna University School of Medicine Hospital_Pediatrics

Kanagawa, Japan

Tokyo Medical University Hospital

Tokyo, Japan

Key Dates

Start Date

August 8, 2024

Primary Completion Date

April 30, 2030

Completion Date

April 30, 2030

Last Updated

August 29, 2025

Enrollment

ESTIMATED participants

Conditions

Haemophilia AHaemophilia B

Interventions

Concizumab

DRUG

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

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Haemophilia A, Haemophilia B

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A Study to Investigate the Course of Synovial Hypertrophy in Patients With Haemophilia A on Efanesoctocog Alfa Prophylaxis

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Haemophilia A (Moderate or Severe)Hemophilia, Classic+4 more

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: August 29, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

Post-Marketing Surveillance (All Case Surveillance) on Treatment With Alhemo® in Patients With Haemophilia A or Haemophilia B With Inhibitors

Inclusion Criteria

Exclusion Criteria

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

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