A Study to Learn About Tafamidis in Patients With Transthyretin Amyloid Cardiomyopathy (ATTR-CM) in India

Pfizer

Status: Enrolling

Conditions: Transthyretin Amyloid Cardiomyopathy

Treatments: Drug: Tafamidis

Study type: Observational

Funder types: Industry

Identifiers

NCT06086353

NCT06086353 (Registry Identifier)

B3461106

Details and patient eligibility

About

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.

Enrollment: 15 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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.

Exclusion criteria

• 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.

Trial design

15 participants in 1 patient group

Patients with ATTR-CM in India

Treatment:

Drug: Tafamidis