Safety And Efficacy Evaluation Of Fx-1006A In Subjects With Transthyretin Amyloidosis
Completed · Phase 3
Conditions studied: ATTR-PN
In brief
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for the treatment of ATTR-PN in their respective country and access to prescription tafamidis, subjects may have been withdrawn from the study.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.
Key facts
- Study ID
- NCT00925002
- Run by
- Pfizer
- People needed
- 93
- Starts
- 2009-08-05
- Expected to finish
- 2020-07-08
- Last updated by the study team
- 2021-07-29
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
Where it is running
- Johns Hopkins Hospital — Baltimore, Maryland, United States
- FLENI — Buenos Aires, Argentina
- Hospital Universitário Clementino Fraga Filho -HUCFF Universidade Federal do Rio de Janeiro — Rio de Jameiro, R.J., Brazil
- Centre d'Investigation Clinique — Créteil, France
- Universitatsklinikum Muenster — Münster, Germany
- Centro per lo Studio e la Cura delle Amiloidosi Sistemiche IRCCS - Policlinico San Matteo — Pavia, Italy
- Centro Hospitalar Lisboa Norte, EPE- Hospital de Santa Maria — Lisbon, Portugal
- Unidade Clinica de Paramiloidose Centro Hospitalar do Porto, EPE - Hospital Geral de Santo António — Porto, Portugal
- FAP-Teamet Familjar Amyloidos — Umeå, Sweden
Full record on ClinicalTrials.gov
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