NCT04814186

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

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 53 (actual)
• Sponsor: Pfizer · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Transthyretin Amyloid Cardiomyopathy

Interventions

Type	Name	Description
DRUG	Tafamidis	61 mg, once daily, oral administration, for 12 months.

Timeline

• Start date: 2021-07-22
• Primary completion: 2023-10-16
• Completion: 2023-10-16
• First posted: 2021-03-24
• Last updated: 2024-12-18
• Results posted: 2024-12-18

Locations

9 sites across 1 country: China

Regulatory

• FDA-regulated drug study