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Clinical Trials in Japan / NCT06285071
Enrolling by invitation Observational

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

NCT06285071 · tracked via the Priya Life Science Japan tracker
Sponsor
Novo Nordisk A/S
Phase
Observational
Started
2024-08-08
Last updated
2026-06-15

Condition(s) studied

Haemophilia AHaemophilia B

Investigational drug(s) / intervention(s)

Concizumab →

Concizumab: 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.

Study 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

Sex
ALL
Min age
—
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 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

Primary outcome measure(s)

  • Number of adverse reaction (AR) — From baseline (week 0) to end of study (week 104)
    Measured as count of ARs.

Trial sites (11)

FacilityCityRegionStatus
Novo Nordisk Investigational Site Toshima City Tokyo
Mutsu general hospital_Pediatrics Aomori Japan
Kyushu university hospital_Pediatrics Fukuoka Japan
Sapporo Tokushukai Hospital_Pediatrics Hokkaido Japan
Kagoshima City Hospital_Pediatrics Kagoshima Japan
St. Marianna University School of Medicine Hospital_Pediatrics Kanagawa Japan
Hospital of the University of Occupational And Environmental Health Japan_Pediatrics Kitakyusyu-shi, Fukuoka Japan
Nanbu Medical Center & Children's Medical Center_Hematology and Oncology Okinawa Japan
University of the Ryukyus Hospital_Endocrinology and Metabolism, Hematology and Rheumatology Okinawa Japan
Tokyo Medical University Hospital Tokyo Japan
Ogikubo Hospital_Blood Coagulation Tokyo Japan

More Novo Nordisk A/S trials in Japan

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AMAZE 13: A Research Study Investigating How Well the Medicine Zenagamtide Helps People in Asia With Excess Body Weight Lose Weight Starting soon
A Research Study to Look at Long-term Treatment With a Medicine Called NNC6019-0001 for People Who Have Heart Failure Due to Transthyretin Amyloidosis Active, not recruiting
CLEOPATTRA: A Research Study to Look at the Effects of Treatment With a Medicine Called Coramitug (NNC6019-0001) in People With Heart Failure Due to Transthyretin Amyloid (ATTR) Amyloidosis Recruiting

Other trials for the same condition

A Research Study Looking at Long-term Treatment With Mim8 in People With Haemophilia A Active, not recruiting
A Research Study Investigating Denecimig (Mim8) in Adults With Acquired Haemophilia A Starting soon
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 NCT06285071 on ClinicalTrials.gov ↗ ← All trials in Japan