A Study to Assess the Safety and Efficacy Of Tafamidis In Chinese Participants With Transthyretin Amyloid Cardiomyopathy (ATTR-CM)
NCT ID: NCT04814186
Last Updated: 2024-12-18
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
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COMPLETED
PHASE4
53 participants
INTERVENTIONAL
2021-07-22
2023-10-16
Brief Summary
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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).
Detailed Description
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Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Chinese participants treated with Tafamidis
treatment group with tafamidis
Tafamidis
61 mg, once daily, oral administration, for 12 months.
Interventions
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Tafamidis
61 mg, once daily, oral administration, for 12 months.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. For the reproductive criteria for male and female participants, please refer to relevant protocol sections.
Exclusion Criteria
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).
18 Years
ALL
No
Sponsors
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Pfizer
INDUSTRY
Responsible Party
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Principal Investigators
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Pfizer CT.gov Call Center
Role: STUDY_DIRECTOR
Pfizer
Locations
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Peking University First Hospital
Beijing, Beijing Municipality, China
Peking University Third Hospital
Beijing, Beijing Municipality, China
Peking Union Medical College Hospital
Beijing, Beijing Municipality, China
Tongji Hospital, Tongji Medical College, Huazhong University of Science & Technology
Wuhan, Hubei, China
The Second Xiangya Hospital of Central South University
Changsha, Hunan, China
The First Affiliated Hospital of Dalian Medical University
Dalian, Liaoning, China
West China Hospital of Sichuan University
Chengdu, Sichuan, China
The Second Affiliated Hospital of Zhejiang University School of Medicine
Hangzhou, Zhejiang, China
Ruijin Hospital, Shanghai Jiaotong University School of Medicine
Shanghai, , China
Countries
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References
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Tian Z, Peng D, Ma W, Yan J, Wang J, Tang Y, Jin W, Liu Y, Jia C, Gao Y, Gong Y, Sun X, Chen N, Zhu S, Zhang S. Safety and Efficacy of Tafamidis in Chinese Patients with Transthyretin Amyloid Cardiomyopathy. Cardiol Ther. 2025 Sep;14(3):439-452. doi: 10.1007/s40119-025-00408-6. Epub 2025 May 23.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Related Links
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To obtain contact information for a study center near you, click here.
Other Identifiers
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B3461077
Identifier Type: -
Identifier Source: org_study_id