Korean Post-marketing Surveillance Vyndamax® Capsules for the Treatment of Transthyretin Amyloid Cardiomyopathy

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Total Enrollment

110 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-06-29

Study Completion Date

2026-12-31

Brief Summary

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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.

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Detailed Description

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Conditions

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ATTR-CM (Transthyretin Amyloid Cardiomyopathy)

Study Design

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Observational Model Type

COHORT

Study Time Perspective

OTHER

Study Groups

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Adults diagnosed with transthyretin-mediated amyloidosis (ATTR-CM)

Vyndamax (tafamidis 61mg)

Intervention Type DRUG

As prescribed in real world practice

Interventions

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Vyndamax (tafamidis 61mg)

As prescribed in real world practice

Intervention Type DRUG

Other Intervention Names

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Tafamadis

Eligibility Criteria

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Inclusion Criteria

* 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

Minimum Eligible Age

19 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No