At a glance
ClinicalIndex Comparison RecordPhase 4Completed· 15 enrolled
Drug / intervention
tafamidis megluminedrug
Likely dose
tafamidis meglumine 20 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A SINGLE ARM, MULTICENTER, OPEN-LABEL STUDY TO EVALUATE THE EFFICACY, SAFETY, TOLERABILITY, AND PHARMACODYNAMICS OF ORALLY ADMINISTERED TAFAMIDIS MEGLUMINE IN TRANSTHYRETIN AMYLOID POLYNEUROPATHY PARTICIPANTS IN CHINA
In Brief
A Phase 4 clinical trial evaluating tafamidis meglumine for Transthyretin Amyloid Polyneuropathy (ATTR-PN). Completed, enrolled 15 participants across 9 sites.
Detailed Summary
This is a single-arm, open-label, multicenter study designed to evaluate the efficacy, safety, tolerability as well as pharmacodynamics of tafamidis meglumine in ATTR-PN participants in China. Approximately 10-15 participants are planned to be enrolled. All enrolled participants will receive oral tafamidis meglumine 20 mg soft capsules once daily for 72 weeks (18 months).
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesChina
Collaborators--
Timeline
Phase 4CompletedFinished
20222023202420252026
First PostedApr 2021
Enrollment StartApr 2021
Primary CompletionFeb 2023
TodayJul 2026
First PostedApr 2, 2021
Enrollment StartApr 28, 2021
Primary CompletionFeb 12, 2023
TodayJul 2, 2026
Enrollment to primary: 1.8 yearsPosted 5.3 years ago
Interventions
tafamidis megluminedrug
Tafamidis meglumine 20 mg, once daily, oral administration, for 72 weeks (18 months).