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

Last updated: November 25, 2024
Sponsor: Pfizer
Overall Status: Completed

Phase

4

Condition

Circulation Disorders

Amyloidosis

Treatment

Tafamidis

Clinical Study ID

NCT04814186
B3461077
  • Ages > 18
  • All Genders

Study 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).

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Subject has documented ATTR-CM.

  2. For the reproductive criteria for male and female participants, please refer torelevant protocol sections.

Exclusion

Exclusion Criteria:

  1. Other acute or chronic medical or psychiatric condition including recent or activesuicidal ideation or behavior or laboratory abnormality, in the judgment of theinvestigator, 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 livespreceding the first dose of study intervention used in this study (whichever islonger).

Study Design

Total Participants: 53
Treatment Group(s): 1
Primary Treatment: Tafamidis
Phase: 4
Study Start date:
July 22, 2021
Estimated Completion Date:
October 16, 2023

Connect with a study center

  • Peking Union Medical College Hospital

    Beijing, Beijing 100730
    China

    Site Not Available

  • Peking University First Hospital

    Beijing, Beijing 100034
    China

    Site Not Available

  • Peking University Third Hospital

    Beijing, Beijing 100191
    China

    Site Not Available

  • Tongji Hospital, Tongji Medical College, Huazhong University of Science & Technology

    Wuhan, Hubei 430030
    China

    Site Not Available

  • The Second Xiangya Hospital of Central South University

    Changsha, Hunan 410011
    China

    Site Not Available

  • The First Affiliated Hospital of Dalian Medical University

    Dalian, Liaoning 116014
    China

    Site Not Available

  • West China Hospital of Sichuan University

    Chengdu, Sichuan 610041
    China

    Site Not Available

  • The Second Affiliated Hospital of Zhejiang University School of Medicine

    Hangzhou, Zhejiang 310009
    China

    Site Not Available

  • Ruijin Hospital, Shanghai Jiaotong University School of Medicine

    Shanghai, 200025
    China

    Site Not Available

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