Menu
Enrolling by invitation NCT06285071

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

— Observational Haemophilia A Haemophilia B

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Concizumab.
Who it may be relevant to
Registry conditions: Haemophilia A, Haemophilia B. Basic parameters: No limits · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Japan
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Interventions

  • Drug 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.

Primary outcome measures

  • Number of adverse reaction (AR) [Time frame: From baseline (week 0) to end of study (week 104)]
Secondary outcome measures (7)
  • Number of serious adverse reaction (SAR) [Time frame: From baseline (week 0) to end of study (week 104)]
  • Number of serious adverse event (SAE) [Time frame: From baseline (week 0) to end of study (week 104)]
  • Number of thromboembolic adverse event (AE) [Time frame: From baseline (week 0) to end of study (week 104)]
  • Number of shock/anaphylaxis AE [Time frame: From baseline (week 0) to end of study (week 104)]
  • Number of treated spontaneous and traumatic bleeding episodes [Time frame: From baseline (week 0) to end of study (week 104)]
  • Number of treated spontaneous and traumatic target joint bleeding episodes [Time frame: From baseline (week 0) to end of study (week 104)]
  • Number of all treatment requiring bleeding episode [Time frame: From baseline (week 0) to end of study (week 104)]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Case-only

Study locations

Japan · 11 centers
  • Novo Nordisk Investigational Site — Toshima City
  • Mutsu general hospital_Pediatrics — Aomori
  • Kyushu university hospital_Pediatrics — Fukuoka
  • Sapporo Tokushukai Hospital_Pediatrics — Hokkaido
  • Kagoshima City Hospital_Pediatrics — Kagoshima
  • St. Marianna University School of Medicine Hospital_Pediatrics — Kanagawa
  • Hospital of the University of Occupational And Environmental Health Japan_Pediatrics — Kitakyusyu-shi, Fukuoka
  • Nanbu Medical Center & Children's Medical Center_Hematology and Oncology — Okinawa
  • … and 3 more centers

Identifiers

NCT: NCT06285071 · NN7415-7557 · U1111-1274-4740

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗