A Study to Assess the Safety and Efficacy Of Tafamidis In Chinese Participants With Transthyretin Amyloid Cardiomyopathy (ATTR-CM)
Status and phase
Conditions
Treatments
Details and patient eligibility
About
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).
Enrollment
Sex
Ages
Volunteers
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).
Trial design
Primary purpose
Allocation
Interventional model
Masking
53 participants in 1 patient group
Trial contacts and locations
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Data sourced from clinicaltrials.gov
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