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Набор по приглашению NCT06831734

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

— Наблюдательное Haemophilia A, Haemophilia B

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Concizumab.
Кому может быть актуально
Состояния в реестре: Haemophilia A, Haemophilia B. Базовые параметры: от 12 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Япония
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

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

Обзор

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.

Вмешательства

  • Препарат 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.

Первичные конечные точки

  • Number of adverse reaction (AR) [Срок оценки: From baseline (week 0) to end of study (week 104)]
Вторичные конечные точки (7)
  • Number of serious adverse reaction (SAR) [Срок оценки: From baseline (week 0) to end of study (week 104)]
  • Number of serious adverse event (SAE) [Срок оценки: From baseline (week 0) to end of study (week 104)]
  • Number of thromboembolic adverse event (AE) [Срок оценки: From baseline (week 0) to end of study (week 104)]
  • Number of shock/anaphylaxis adverse event (AE) [Срок оценки: From baseline (week 0) to end of study (week 104)]
  • Number of treated spontaneous and traumatic bleeding episodes [Срок оценки: From baseline (week 0) to end of study (week 104)]
  • Number of treated spontaneous and traumatic target joint bleeding episodes [Срок оценки: From baseline (week 0) to end of study (week 104)]
  • Number of all treatment requiring bleeding episodes [Срок оценки: From baseline (week 0) to end of study (week 104)]

Критерии участия

Критерии включения

  • 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.

Критерии исключения

  • 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Дизайн исследования

Модель наблюдения
Когортное

Центры проведения

Япония · 23 центра
  • 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
  • … и ещё 15 центров

Идентификаторы

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

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗