Safety And Efficacy Evaluation Of Fx-1006A In Subjects With Transthyretin Amyloidosis
Status:
Completed
Trial end date:
2020-07-08
Target enrollment:
Participant gender:
Summary
This is a Phase 3, open-label study designed to obtain additional long-term safety and
efficacy data for oral tafamidis (20 mg soft gelatin capsule) administered once daily (QD).
In addition, this study continued to provide tafamidis to Val30Met subjects who had completed
Protocol Fx-006 (a 1-year, open-label extension study to Protocol Fx-005 which was a
randomized, double-blind, placebo-controlled, 18-month study to evaluate the safety and
efficacy of tafamidis) or non-Val30Met subjects who had completed Protocol Fx1A-201 (a Phase
2, open-label study to evaluate TTR stabilization, safety, and tolerability of tafamidis) for
up to 10 years or until subjects had access to tafamidis for ATTR-PN via prescription. Upon
regulatory approval for the treatment of ATTR-PN in their respective country and access to
prescription tafamidis, subjects may have been withdrawn from the study. Such subjects were
considered study completers.