A Study of OBIZUR in Adults With Acquired Hemophilia A (AHA) in South Korea

Официальное название

Post-Marketing Surveillance (Use-result Surveillance) of OBIZUR Injection [Susoctocog Alpha (Porcine Antihemophilic Factor VIII, Recombinant)] for the Approved Indications in South Korea

Обзор

Acquired hemophilia A (AHA) is a rare bleeding condition which prevents blood clotting. Acquired means that people are not born with this condition or have a family history of blood clotting conditions. People living with AHA can have sudden and severe bleeding. They also have longer bleeding compared to people without AHA. The main aim of the study is to learn how safe OBIZUR is in adults with AHA. Other aims are to see how effective OBIZUR is to control bleeding and how treatment is used in a routine clinical practice setting. The treatment of the participants will be determined by the treating physicians. During the study, data already existing in the participants' medical record and new data will be collected.

Подробное описание

This is a prospective, and retrospective, multicenter, single-arm non-interventional post-marketing surveillance study.

Вмешательства

• Препарат OBIZUR
  OBIZUR injection.

Первичные конечные точки

• Number of Participants With Adverse Events (AEs), Causality to AEs, Serious AEs (SAEs) and AEs of Special Interest (AESI) [Срок оценки: Up to 3 months]
• Number of Participants With Expected/Unexpected AEs and SAEs [Срок оценки: Up to 3 months]
• Number of Participants With Adverse Drug Reactions (ADRs), Unexpected ADRs, Serious ADRs, Expected SADRs and Unexpected SADRs [Срок оценки: Up to 3 months]
• Number of Participants With Special Situation Report (SSR) [Срок оценки: Up to 3 months]

Вторичные конечные точки (5)

• Percentage of Participants With Overall Bleeding Control [Срок оценки: Up to 3 months]
• Time to Achieve Bleeding Control With OBIZUR Injection [Срок оценки: Up to 3 months]
• Number of OBIZUR Injection Infusion Required to Achieve Bleeding Control [Срок оценки: Up to 3 months]
• Dose of OBIZUR Required to Stop the Bleeding [Срок оценки: Up to 3 months]
• Percentage of Participants With Bleeding Events [Срок оценки: Up to 3 months]

Критерии участия

Критерии включения

• Participants with AHA.
• Participants who are determined to have the clinical need to receive Obizur treatment.
• Participants aged 18 years or older at time of initiation of Obizur treatment.
• Participants agreed to participate in the study and voluntarily signed the informed consent.

Критерии исключения

• Participants with hypersensitivity to any of the components of this drug.
• Participants with Congenital Hemophilia A with Inhibitors (CHAWI).
• Participants for whom Obizur treatment is contraindicated as per product label.
• Participants who has participated in another clinical study involving a medicinal product or device within 30 days prior to enrollment or is scheduled to participate in another clinical study involving a medicinal product or device during the course of the study.

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

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

South Korea · 4 центра

• Kyung Hee University Hospital at Gangdong — Seoul
• The Catholic University of Korea, Seoul St. Mary's Hospital — Seoul
• Ewha Womans University Medical Center — Seoul
• Ulsan University Hospital — Ulsan

Идентификаторы

NCT: NCT06550882 · TAK-672-4002

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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