ATTR-CM (Transthyretin Amyloid Cardiomyopathy) Clinical Trial
Official title:
KOREAN POST-MARKETING SURVEILLANCE VYNDAMAX (Registered) CAPSULES FOR THE TREATMENT OF TRANSTHYRETIN AMYLOID CARDIOMYOPATHY (ATTR-CM)
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.
| Status | Recruiting |
| Enrollment | 100 |
| Est. completion date | March 30, 2030 |
| Est. primary completion date | March 30, 2030 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 19 Years and older |
| Eligibility | *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. - Exclusion criteria 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 |
| Country | Name | City | State |
|---|---|---|---|
| Korea, Republic of | Pfizer | Seoul |
| Lead Sponsor | Collaborator |
|---|---|
| Pfizer |
Korea, Republic of,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | The incidence of Adverse Events (AEs) | 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. |
Baseline through 6 months of treatment | |
| Secondary | Change from baseline in the New York Heart Association (NYHA) class at Month 6 | Baseline, month 6 | ||
| Secondary | Change from baseline in the 6 Minute Walk Distance (6MWD) at Month 6 | Baseline, month 6 | ||
| Secondary | Global assessment by investigator at Month 6 | Baseline, month 6 |