A Study to Characterize the Safety and Efficacy of Tafamidis Once Daily in the Treatment of Transthyretin Amyloid Cardiomyopathy in Chinese Participants

  • STATUS
    Recruiting
  • End date
    Dec 18, 2025
  • participants needed
    53
  • sponsor
    Pfizer
Updated on 23 September 2022

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, 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).

Details
Condition Transthyretin Amyloid Cardiomyopathy
Treatment tafamidis
Clinical Study IdentifierNCT04814186
SponsorPfizer
Last Modified on23 September 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

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

Exclusion Criteria

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)
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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