A Study to Learn About the Study Medicine Called Tafamidis 61mg in People Diagnosed With Transthyretin Amyloid Cardiomyopathy (ATTR-CM)

NCT ID: NCT06321523

Last Updated: 2025-11-20

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

COMPLETED

Total Enrollment

13 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-03-19

Study Completion Date

2025-10-13

Brief Summary

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The purpose of this clinical trial is to learn about the effects of the study medicine (called Tafamidis 61milligrams (mg)) for the potential treatment of Transthyretin amyloid cardiomyopathy (ATTR-CM).

This study is seeking participants who were prescribed Tafamidis 61mg after being diagnosed with ATTR-CM and have taken Tafamidis 61mg at least once.

We will examine the experiences of people receiving the study medicine. This will help us determine if the study medicine is safe and effective.

Detailed Description

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Conditions

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Transthyretin Amyloid Cardiomyopathy

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

RETROSPECTIVE

Study Groups

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ATTR-CM patients in Korea

transthyretin amyloid cardiomyopathy (ATTR-CM) patients in Korea

Tafamidis 61 milligrams

Intervention Type DRUG

Tafamidis 61mg as provided in real-world practice

Interventions

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Tafamidis 61 milligrams

Tafamidis 61mg as provided in real-world practice

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Age ≥19 years
* Patients diagnosed with ATTR-CM (ATTRwt and ATTRv) with tissue biopsy or nuclear scintigraphy
* Patients who was prescribed Tafamidis 61mg after being diagnosed with ATTR-CM and have taken Tafamidis 61mg at least once.

Exclusion Criteria

* Presence of other amyloidosis
Minimum Eligible Age

19 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Pfizer

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

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Severance Hopital, Yonsei University Health System

Seoul, Seoul-teukbyeolsi [seoul], South Korea

Site Status

Samsung Medical Center

Seoul, Seoul-teukbyeolsi [seoul], South Korea

Site Status

Pusan National University Hospital

Busan, , South Korea

Site Status

Gangnam Severance Hospital

Seoul, , South Korea

Site Status

Countries

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South Korea

Related Links

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https://pmiform.com/clinical-trial-info-request?StudyID=B3461122

To obtain contact information for a study center near you, click here.

Other Identifiers

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NCT06321523

Identifier Type: REGISTRY

Identifier Source: secondary_id

B3461122

Identifier Type: -

Identifier Source: org_study_id

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