KOREAN POST-MARKETING SURVEILLANCE VYNDAMAX (REGISTERED) CAPSULES FOR THE TREATMENT OF TRANSTHYRETIN AMYLOID CARDIOMYOPATHY (ATTR-CM)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 110
- 试验地点
- 2
- 主要终点
- The incidence of Adverse Events (AEs)
研究概览
简要总结
This non-interventioal study will be performed by design of post-marketing surveillance (PMS) as an additional pharmacovigilance activity of the Risk Management Plan (RMP) for Vyndamax® Capsules, which is required by the Ministry of Food and Drug Safety (MFDS) according to the local regulation. This post-marketing surveillance will investigate the safety and effectiveness of Vyndamax® Capsules as the treatment of transthyretin amyloid cardiomyopathy during 10 years under the setting of routine practice in Korea.
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
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •*Inclusion Criteria:
- •Patients must meet all of the following inclusion criteria to be eligible for inclusion in the study:
- •1. Adult patients with the cardiomyopathy of wild type or hereditary transthyretin-mediated amyloidosis (ATTR-CM)
- •2. Patients to whom Vyndamax® Capsules is prescribed for the treatment of the cardiomyopathy of wild type or hereditary transthyretin-mediated amyloidosis (ATTR-CM)
- •3. Evidence of a personally signed and dated informed consent document indicating that the patient (or a legally acceptable representative) has been informed of all pertinent aspects of the study.
排除标准
- •Patients meeting any of the following criteria will not be included in the study according to the local product label:
- •1. Patient with hypersensitivity or case history to tafamidis or to any of the excipients in the product
- •2. This product contains sorbitol (E420). Patients with rare hereditary problems of fructose intolerance should not take this medicine.
- •3. Patient who has a contraindication to Vyndamax® Capsules according to the approved local product label
研究组 & 干预措施
Adults diagnosed with transthyretin-mediated amyloidosis (ATTR-CM)
干预措施: Vyndamax (tafamidis 61mg) (Drug)
结局指标
主要结局
The incidence of Adverse Events (AEs)
时间窗: Baseline through 6 months of treatment
The primary interest of this study is the incidence of AEs investigated during administration period and within 28 days after discontinuation of Vyndamax® Capsules. Incidence of AEs, 95% confidence interval and the number of AEs will be presented. Serious AEs/ADRs, unexpected AEs/ADRs, unexpected serious AEs/ADRs will be summarized separately table.
次要结局
- Global assessment by investigator at Month 6(Baseline, month 6)
- Change from baseline in the New York Heart Association (NYHA) class at Month 6(Baseline, month 6)
- Change from baseline in the 6 Minute Walk Distance (6MWD) at Month 6(Baseline, month 6)