To Evaluate the Efficacy and Safety of Tafamidis Meglumine Soft Capsules in the Treatment of Adult Patients With Transthyretin Amyloid Polyneuropathy
Trial Parameters
Brief Summary
The purpose of this study is to evaluate the efficacy and safety of Tafamidis Meglumine Soft Capsules in the Treatment of Adult Patients with Transthyretin Amyloid Polyneuropathy
Eligibility Criteria
Inclusion Criteria: * Male or female participants between the ages of 18 and 80 years. * Participant has amyloid deposits confirmed by biopsy (Biopsy must have been performed within 5 years prior to enrollment). * Participant must have a TTR mutation that is associated with ATTR-PN (TTR mutation test must have been performed within 5 years prior to enrollment). * Participant has peripheral neuropathy at screening. * Participant has a Karnofsky Performance Status Score ≥50. * Stages of disease according to symptom severity-stage 1. Exclusion Criteria: * Participant has other causes of amyloidosis, such as light chain amyloidosis, AA amyloidosis. * Participant has used tafamidis within 2 months prior to enrollment. * Participant has used diflunisal, patisiran, inotersen, or other agents for familial amyloidosis within 30 days prior to enrollment or plan to use them during the study period. * Participant has used non-protocol NSAIDs more than 4 times within 30 days prior to enrollment or