A Prospective, Single-arm, Multicenter, Observational Safety Surveillance Study of VyndaMx® (Tafamidis Capsule 61 mg) in Patients With Transthyretin Amyloid Cardiomyopathy (ATTR-CM) in India
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 6
- 试验地点
- 3
- 主要终点
- Number of Adverse events with Tafamidis
研究概览
简要总结
The purpose of this study is to learn about the safety of Tafamidis for the treatment of Transthyretin amyloid cardiomyopathy (ATTR-CM) in India.
ATTR-CM is a condition that affects people's hearts. Transthyretin is a protein that is made in the liver. In some people this protein stops working and forms clumps called as amyloid. Transthyretin amyloid builds up in heart and stops the heart from pumping properly.
This study is seeking for participants who are:
- confirmed with ATTR-CM.
- given Tafamidis capsules to be taken by mouth.
The safety of Tafamidis capsules will be checked based on side effects. These side effects can happen within 6 months after taking Tafamidis. A side effect is something (expected or unexpected) that you feel was caused by a medicine or treatment you take. The study doctor will collect side effect information and put the information on patient's case form.
Follow-up of the patient's will be performed via clinic re-visit or over a call. It is not a rule for the participants to visit the clinic in this study.
This study will help to see if Tafamidis is safe.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult patients (age ≥18 years) with diagnosis of cardiomyopathy of wild type or hereditary transthyretin-mediated amyloidosis (ATTR-CM).
- •Patients to whom VyndaMx® Capsules is prescribed for the treatment of wild or hereditary ATTR-CM.
排除标准
- •Patient with hypersensitivity to VyndaMx® Capsule or to any of the excipients in the product.
- •Patients with rare hereditary problems of fructose intolerance.
- •Patient who has a contraindication to VyndaMx® Capsules according to the approved local product label.
研究组 & 干预措施
Patients with ATTR-CM in India
干预措施: Tafamidis (Drug)
结局指标
主要结局
Number of Adverse events with Tafamidis
时间窗: Baseline to 6 months
The safety of VyndaMx® Capsules is the primary objective of the study and will be assessed based on Adverse events which would occur within 6 months from first dosing. Investigator will collect the safety related data until 6 months from first dosing of Tafamidis Capsules and will record these data on the Case report Form.
次要结局
未报告次要终点