Post Marketing Surveillance Study for Jivi (Damoctocog Alfa Pegol) in Korean Patients With Hemophilia A
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Occurrence of adverse events (AEs)
研究概览
简要总结
In this study, researchers will observe and study the data from participants with hemophilia A who receive damoctocog alfa pegol as prescribed by their doctors. Participants will not receive any advice or changes to their healthcare during the study.
Hemophilia A is a genetic bleeding disorder. It is caused by the lack of a protein called clotting factor 8 (FVIII) that helps blood to clot properly. Lack of FVIII can result in excessive blood loss or bleeding inside the body after being injured or having surgery.
The study drug, damoctocog alfa pegol, can be used to prevent or treat bleeding episodes by replacing missing FVIII in the body of people with hemophilia A. It is already approved for people with hemophilia A who are at least 12 years old and have previously used other hemophilia A treatments.
Through this study, researchers want to learn more about its safety in a real-world setting.
The participants will receive damoctocog alfa pegol as prescribed by their doctors during routine practice according to the approved product information.
The main purpose of this study is to learn more about how safe damoctocog alfa pegol is in Korean participants with hemophilia A who previously used other hemophilia A treatments. To do this, researchers will collect information about any medical problems participants have during their treatment.
Data will be collected from December 2023 to March 2026 and cover a period of about 8 months for each participant. Data will come from participants' health records and information collected during their routine clinic visits.
In this study, only available data from routine care will be collected. No visits or tests are required as part of this study.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 12 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •≥12 years of age with hemophilia A
- •Previously treated with FVIII concentrate(s) (plasma derived or recombinant)
- •Patients who have been treated with Jivi (damoctocog alfa pegol) and those for whom the decision to initiate treatment with Jivi was made as per physician's routine treatment practice with any kind of treatment modality (on-demand, prophylaxis, etc.)
- •Written informed consent from subject or legal representative; assent from subject when appropriate
排除标准
- •Contraindication according to the local authorized indication (including known hypersensitivity to the drug substance or any of its components (e.g., mouse or hamster protein))
- •Patients participating in an investigational program with interventions outside of routine clinical practice
- •Patients with any other diagnosis of bleeding/coagulation disorder other than hemophilia A
- •Patients on immune tolerance induction treatment at the time of enrollment
研究组 & 干预措施
Post-marketing surveillance cohort
Participants follow their usual medical visits with data collection occurs continuously in a 36-week observational period.
干预措施: Damoctocog-alfa-pegol (Jivi, BAY94-9027) (Drug)
结局指标
主要结局
Occurrence of adverse events (AEs)
时间窗: Up to 36 weeks
Number of participants with AEs
Number of adverse events related to overdose
时间窗: Up to 36 weeks
Occurrence of Serious adverse events (SAEs)
时间窗: Up to 36 weeks
Number of participants with SAEs
Occurrence of adverse reactions (ARs)
时间窗: Up to 36 weeks
Number of participants with ARs
Occurrence of Serious adverse reactions (SARs)
时间窗: Up to 36 weeks
Number of participants with SARs
Occurrence of adverse events of important identified risks (AESIs)
时间窗: Up to 36 weeks
Important identified risks include development of Factor VIII inhibitors/Hypersensitivity/Clinical response characterised by lack of drug effect associated with anti-polyehtylene glycol (PEG) antibodies.
Number of adverse events related to previously taken drugs and concomitant drugs
时间窗: Up to 36 weeks
次要结局
- Difference in annualized total number of injections, injection frequency from previous FVIII products versus Jivi (damoctocog alfa pegol)(Up to 36 weeks)
- Annualized number of reported total bleeds(Up to 36 weeks)
- Difference annualized total/average factor consumption (for overall, prophylaxis, bleeds(Intermittent prophylaxis), and other events) from previous FVIII products versus Jivi (damoctocog alfa pegol)(Up to 36 months)
- Regimen selection determinants (physician and patient)(Up to 36 weeks)
- Number of patients with 0 bleeds, and the difference in proportion comparing to previous prophylaxis treatment(Up to 36 weeks)
- ABR during the study compared with ABR for previous FVIII products in the 12 months prior to enrollment into the study(Up to 36 weeks)