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Enrolling by invitation NCT06831734

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

— 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: from 12 years · 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

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

Overview

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.

Interventions

  • Drug 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.

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 adverse event (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 episodes [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 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.

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

Study design

Observational model
Cohort

Study locations

Japan · 23 centers
  • Chiba university hospital_Pediatrics — Chiba
  • National Hospital Organization Awara Hospital_Hematology and Oncology — Fukui
  • Hoshi General Hospital_Pediatrics — Fukushima
  • Hyogo Prefectural Amagasaki General Medical Center_Haematology — Hyōgo
  • St. Marianna University School of Medicine Hospital_Pediatrics — Kanagawa
  • Saitama Medical Univ. Hospital Saitama medical center_Department of Transfusion Medicine a — Kawagoe
  • Miyagi Children's Hospital_Hematology-Oncology — Miyagi
  • Nagano Children's Hospital_Hematology-Oncology — Nagano
  • … and 15 more centers

Identifiers

NCT: NCT06831734 · NN7415-7690 · U1111-1286-2960

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗