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A Study to Assess the Safety and Efficacy Of Tafamidis In Chinese Participants With Transthyretin Amyloid Cardiomyopathy (ATTR-CM)

NCT04814186

CompletedPhase 4

Sponsor: Pfizer

Conditions: Transthyretin Amyloid Cardiomyopathy

Interventions: Tafamidis

Countries: China

This is a national, multi-center, single-arm study, open-label to patients with symptomatic Transthyretin amyloid cardiomyopathy (ATTR-CM) who are tafamidis naïve. This study is to obtain safety, descriptive efficacy, Pharmacokinetics (PK) and Pharmacodynamics (PD) data for tafamidis orally once daily. Subject eligibility for participation in the study will receive tafamidis once daily or 12 months following the assessment as the screening and baseline, month 1, 3, 6, 9 and 12 visits (or Early Study Discontinuation).

Eligibility overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

Inclusion Criteria:

1. Subject has documented ATTR-CM.
2. For the reproductive criteria for male and female participants, please refer to relevant protocol sections.

Exclusion Criteria:

1. Other acute or chronic medical or psychiatric condition including recent or active suicidal ideation or behavior or laboratory abnormality, in the judgment of the investigator, would make the participant inappropriate for entry into this study.
2. Participants who have prior liver and/or heart transplant.
3. Participants with primary (light chain) or secondary amyloidosis.
4. Previous administration with an investigational drug within 30 days or 5 half lives preceding the first dose of study intervention used in this study (whichever is longer).

Locations (9)

Beijing, Beijing Municipality, China
Beijing, Beijing Municipality, China
Beijing, Beijing Municipality, China
Wuhan, Hubei, China
Changsha, Hunan, China
Dalian, Liaoning, China
Chengdu, Sichuan, China
Hangzhou, Zhejiang, China
Shanghai, China