Status:
COMPLETED
A Study to Assess the Safety and Efficacy Of Tafamidis In Chinese Participants With Transthyretin Amyloid Cardiomyopathy (ATTR-CM)
Lead Sponsor:
Pfizer
Conditions:
Transthyretin Amyloid Cardiomyopathy
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
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, desc...
Eligibility Criteria
Inclusion
- Subject has documented ATTR-CM.
- For the reproductive criteria for male and female participants, please refer to relevant protocol sections.
Exclusion
- 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.
- Participants who have prior liver and/or heart transplant.
- Participants with primary (light chain) or secondary amyloidosis.
- 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).
Key Trial Info
Start Date :
July 22 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 16 2023
Estimated Enrollment :
53 Patients enrolled
Trial Details
Trial ID
NCT04814186
Start Date
July 22 2021
End Date
October 16 2023
Last Update
December 18 2024
Active Locations (9)
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1
Peking University First Hospital
Beijing, Beijing Municipality, China, 100034
2
Peking University Third Hospital
Beijing, Beijing Municipality, China, 100191
3
Peking Union Medical College Hospital
Beijing, Beijing Municipality, China, 100730
4
Tongji Hospital, Tongji Medical College, Huazhong University of Science & Technology
Wuhan, Hubei, China, 430030