Post-Marketing Surveillance (Use-result Surveillance) of OBIZUR Injection [Susoctocog Alpha (Porcine Antihemophilic Factor VIII, Recombinant)] for the Approved Indications in South Korea
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 9
- 试验地点
- 5
- 主要终点
- Number of Participants With Adverse Events (AEs), Causality to AEs, Serious AEs (SAEs) and AEs of Special Interest (AESI)
研究概览
简要总结
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.
详细描述
This is a prospective, and retrospective, multicenter, single-arm non-interventional post-marketing surveillance study.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Other
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
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.
干预措施: OBIZUR (Drug)
结局指标
主要结局
Number of Participants With Adverse Events (AEs), Causality to AEs, Serious AEs (SAEs) and AEs of Special Interest (AESI)
时间窗: Up to 3 months
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.
Number of Participants With Expected/Unexpected AEs and SAEs
时间窗: Up to 3 months
Unexpected AE is defined as AE that differs from the information in the product label in nature, severity, specificity, or outcome.
Number of Participants With Special Situation Report (SSR)
时间窗: Up to 3 months
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.
Number of Participants With Adverse Drug Reactions (ADRs), Unexpected ADRs, Serious ADRs, Expected SADRs and Unexpected SADRs
时间窗: Up to 3 months
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.
次要结局
- Dose of OBIZUR Required to Stop the Bleeding(Up to 3 months)
- Percentage of Participants With Overall Bleeding Control(Up to 3 months)
- Time to Achieve Bleeding Control With OBIZUR Injection(Up to 3 months)
- Number of OBIZUR Injection Infusion Required to Achieve Bleeding Control(Up to 3 months)
- Percentage of Participants With Bleeding Events(Up to 3 months)