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

Pfizer

Status: Enrolling

Conditions: ATTR-CM (Transthyretin Amyloid Cardiomyopathy)

Treatments: Drug: Vyndamax (tafamidis 61mg)

Study type: Observational

Funder types: Industry

Identifiers

NCT04801329

Vyndamax PMS (Other Identifier)

B3461080

Details and patient eligibility

About

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.

Enrollment: 100 estimated patients

Sex: All

Ages: 19+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

*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

Trial design

100 participants in 1 patient group

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

Treatment:

Drug: Vyndamax (tafamidis 61mg)