한국 성인 AHA(후천성 혈우병) 환자를 대상으로 한 OBIZUR에 대한 연구
국내 허가된 적응증에 대한 오비주르 주사제[서옥토코그 알파(돼지 항혈우병 인자 VIII, 재조합형)]의 시판 후 조사(사용결과 조사)
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.
연구 개요
상세 설명
This is a prospective, and retrospective, multicenter, single-arm non-interventional post-marketing surveillance study.
연구 유형
등록 (추정된)
연락처 및 위치
연구 연락처
- 이름: Takeda Contact
- 전화번호: +1-877-825-3327
- 이메일: medinfoUS@takeda.com
연구 장소
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Seoul, 대한민국, 06591
- 모병
- The Catholic University of Korea, Seoul St. Mary's Hospital
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연락하다:
- Site Contact
- 전화번호: +82-2-2258-5745
- 이메일: royoon@catholic.ac.kr
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수석 연구원:
- Jae-ho Yoon
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Seoul, 대한민국, 05278
- 모병
- Kyung Hee University Hospital at Gangdong
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연락하다:
- Site contact
- 이메일: pysped@khu.ac.kr
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수석 연구원:
- Young Shil Park, Ph.D
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Seoul, 대한민국, 07804
- 모병
- Ewha Womans University Medical Center
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연락하다:
- Site Contact
- 전화번호: +82-2-6986-3100
- 이메일: anemia@khu.ac.kr
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수석 연구원:
- Jae-joon Han
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Ulsan, 대한민국, 44033
- 모병
- Ulsan University Hospital
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수석 연구원:
- Yoo Jin Lee
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연락하다:
- Site Contact
- 전화번호: +82-52-250-7000
- 이메일: yjleeh@uuh.ulsan.kr
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
샘플링 방법
연구 인구
Participants with AHA who are receiving OBIZUR Injection or initiate OBIZUR Injection treatment for the first time will be enrolled.
설명
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.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 관찰 모델: COHORT
- 시간 관점: OTHER
코호트 및 개입
그룹/코호트 |
개입 / 치료 |
|---|---|
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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.
다른 이름들:
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Number of Participants With Adverse Events (AEs), Causality to AEs, Serious AEs (SAEs) and AEs of Special Interest (AESI)
기간: 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
기간: 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
기간: 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)
기간: 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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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Percentage of Participants With Overall Bleeding Control
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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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공동 작업자 및 조사자
스폰서
수사관
- 연구 책임자: Study Director, Takeda
간행물 및 유용한 링크
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (추정된)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
키워드
추가 관련 MeSH 약관
기타 연구 ID 번호
- TAK-672-4002
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
IPD 계획 설명
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.
IPD 공유 액세스 기준
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.
IPD 공유 지원 정보 유형
- 연구_프로토콜
- 수액
- ICF
- CSR
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
미국에서 제조되어 미국에서 수출되는 제품
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