Badanie leku OBIZUR u dorosłych z nabytą hemofilią A (AHA) w Korei Południowej
Nadzór po wprowadzeniu do obrotu (nadzór nad wynikami stosowania) wstrzykiwacza OBIZUR [Susoctocog alfa (świński czynnik przeciwhemofilowy VIII, rekombinowany)] w zakresie zatwierdzonych wskazań w Korei Południowej
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.
Przegląd badań
Szczegółowy opis
This is a prospective, and retrospective, multicenter, single-arm non-interventional post-marketing surveillance study.
Typ studiów
Zapisy (Szacowany)
Kontakty i lokalizacje
Kontakt w sprawie studiów
- Nazwa: Takeda Contact
- Numer telefonu: +1-877-825-3327
- E-mail: medinfoUS@takeda.com
Lokalizacje studiów
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Seoul, Korea Południowa, 06591
- Rekrutacyjny
- The Catholic University of Korea, Seoul St. Mary's Hospital
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Kontakt:
- Site Contact
- Numer telefonu: +82-2-2258-5745
- E-mail: royoon@catholic.ac.kr
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Główny śledczy:
- Jae-ho Yoon
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Seoul, Korea Południowa, 05278
- Rekrutacyjny
- Kyung Hee University Hospital at Gangdong
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Kontakt:
- Site contact
- E-mail: pysped@khu.ac.kr
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Główny śledczy:
- Young Shil Park, Ph.D
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Seoul, Korea Południowa, 07804
- Rekrutacyjny
- Ewha Womans University Medical Center
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Kontakt:
- Site Contact
- Numer telefonu: +82-2-6986-3100
- E-mail: anemia@khu.ac.kr
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Główny śledczy:
- Jae-joon Han
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Ulsan, Korea Południowa, 44033
- Rekrutacyjny
- Ulsan University Hospital
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Główny śledczy:
- Yoo Jin Lee
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Kontakt:
- Site Contact
- Numer telefonu: +82-52-250-7000
- E-mail: yjleeh@uuh.ulsan.kr
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Kryteria uczestnictwa
Kryteria kwalifikacji
Wiek uprawniający do nauki
Akceptuje zdrowych ochotników
Płeć kwalifikująca się do nauki
Metoda próbkowania
Badana populacja
Participants with AHA who are receiving OBIZUR Injection or initiate OBIZUR Injection treatment for the first time will be enrolled.
Opis
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Plan studiów
Jak projektuje się badanie?
Szczegóły projektu
- Modele obserwacyjne: COHORT
- Perspektywy czasowe: OTHER
Kohorty i interwencje
Grupa / Kohorta |
Interwencja / Leczenie |
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All Participants
Participants with AHA who are receiving OBIZUR injection or initiate OBIZUR Injection treatment for the first time will be enrolled. Both retrospective and prospective participants data will be collected. Retrospective data will be collected from the date of first treatment with OBIZUR injection after the marketing authorization in Korea but before date of signed informed consent and prospective data will be collected from the date of signed informed consent. The treatment and follow up of the participants will be determined by the treating physicians according to her/his routine practice. |
OBIZUR injection.
Inne nazwy:
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Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
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Number of Participants With Adverse Events (AEs), Causality to AEs, Serious AEs (SAEs) and AEs of Special Interest (AESI)
Ramy czasowe: Up to 3 months
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Number of participants with AEs, causality to AEs, SAEs and AESI will be reported. The investigator will assess the causal relationship (causality) between the medicinal product and the AE using his/her clinical expertise and judgment. |
Up to 3 months
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Number of Participants With Expected/Unexpected AEs and SAEs
Ramy czasowe: Up to 3 months
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Unexpected AE is defined as AE that differs from the information in the product label in nature, severity, specificity, or outcome. |
Up to 3 months
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Number of Participants With Adverse Drug Reactions (ADRs), Unexpected ADRs, Serious ADRs, Expected SADRs and Unexpected SADRs
Ramy czasowe: Up to 3 months
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An ADR refers to any undesirable and unintended reaction which occurs during or following the administration of the drug, and in which a causal relationship with the drug cannot be ruled out. In the event that a causal relationship with the drug remains unknown amongst reported adverse events, such reaction shall be considered an adverse drug reaction. Serious ADR means noxious or unintended response to a drug that occurs at any dosage and that requires in-patient hospitalization or prolongation of existing hospitalization, causes congenital malformation, results in persistent or significant disability or incapacity, is life-threatening or results in death. Unexpected ADRs is defined as ADR that differs from the information in the product label in nature, severity, specificity, or outcome. |
Up to 3 months
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Number of Participants With Special Situation Report (SSR)
Ramy czasowe: Up to 3 months
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SSR include following events: Pregnancy: any case in which a pregnancy participant is exposed to a Takeda Product or in which a female participant or partner of a male participant becomes pregnant following Takeda product.; Breastfeeding: infant exposure from breast milk; Overdose: all information of any accidental or intentional overdose; Drug abuse, misuse or medication error: all information on medicinal product (MP) abuse, misuse of medication error (potential or actual); Suspected transmission of infectious agent: Suspected (in sense of confirmed or potential) transmission of infectious agent by a MP; Lack of efficacy of Takeda Product; accidental/occupational exposure; Use outside the terms of the marketing authorization, also known as "off-label" and "off-label use"; Use of falsified and counterfeit MP; Drug-drug and drug-food interactions; Inadvertent or accidental exposure with or without an AE; Unintended benefit. |
Up to 3 months
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Miary wyników drugorzędnych
Miara wyniku |
Opis środka |
Ramy czasowe |
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Percentage of Participants With Overall Bleeding Control
Ramy czasowe: Up to 3 months
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Overall Bleeding Control will be determined as either bleeding stopped or did not stop. |
Up to 3 months
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Time to Achieve Bleeding Control With OBIZUR Injection
Ramy czasowe: Up to 3 months
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Time to achieve bleeding control will be assessed from initiation of OBIZUR Injection (start time) to the time to achieve bleeding control (stop time). |
Up to 3 months
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Number of OBIZUR Injection Infusion Required to Achieve Bleeding Control
Ramy czasowe: Up to 3 months
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Number of OBIZUR injection infusion required to achieve bleeding control will be reported. |
Up to 3 months
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Dose of OBIZUR Required to Stop the Bleeding
Ramy czasowe: Up to 3 months
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OBIZUR dose required to stop the bleeding will be reported. |
Up to 3 months
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Percentage of Participants With Bleeding Events
Ramy czasowe: Up to 3 months
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Bleeding events will be evaluated and reported as re-bleed, concurrent bleed and subsequent bleed. Re-bleed: if it occurs in the same anatomical location and within 72 hours of the resolution of the previous bleeding. Concurrent bleed: if it occurs at the same time (that is, during treatment or within 72 hours of resolution) as previous bleed but at a different anatomical location. Subsequent bleed: if it is a new bleed occurring 72 hours after the resolution of the previous bleed (either in the same anatomical location or in a new one). |
Up to 3 months
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Współpracownicy i badacze
Sponsor
Śledczy
- Dyrektor Studium: Study Director, Takeda
Publikacje i pomocne linki
Daty zapisu na studia
Główne daty studiów
Rozpoczęcie studiów (Rzeczywisty)
Zakończenie podstawowe (Szacowany)
Ukończenie studiów (Szacowany)
Daty rejestracji na studia
Pierwszy przesłany
Pierwszy przesłany, który spełnia kryteria kontroli jakości
Pierwszy wysłany (Rzeczywisty)
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
Ostatnia weryfikacja
Więcej informacji
Terminy związane z tym badaniem
Słowa kluczowe
Dodatkowe istotne warunki MeSH
Inne numery identyfikacyjne badania
- TAK-672-4002
Plan dla danych uczestnika indywidualnego (IPD)
Planujesz udostępniać dane poszczególnych uczestników (IPD)?
Opis planu IPD
Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.
Kryteria dostępu do udostępniania IPD
IPD from eligible studies will be shared with qualified researchers according to the criteria and process described on https://vivli.org/ourmember/takeda/. For approved requests, the researchers will be provided access to anonymized data (to respect patient privacy in line with applicable laws and regulations) and with information necessary to address the research objectives under the terms of a data sharing agreement.
Typ informacji pomocniczych dotyczących udostępniania IPD
- PROTOKÓŁ BADANIA
- SOK ROŚLINNY
- ICF
- CSR
Informacje o lekach i urządzeniach, dokumenty badawcze
Bada produkt leczniczy regulowany przez amerykańską FDA
Bada produkt urządzenia regulowany przez amerykańską FDA
produkt wyprodukowany i wyeksportowany z USA
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