To Evaluate the Efficacy and Safety of Tafamidis Meglumine Soft Capsules in the Treatment of Adult Patients With Transthyretin Amyloid Polyneuropathy

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 plan to use them more than 4 times per month during the study period.
• Participant has used doxycycline,tauroursodeoxycholate within 14 days prior to enrollment or plan to use them during the study period.
• Participant has sensory motor neuropathy caused by other causes, such as chronic inflammatory demyelinating polyradiculopathy, chronic idiopathic axonal neuropathy, diabetic neuropathy, chronic alcoholic neuropathy, paraneoplastic neuropathy,Guillain-Barre syndrome, vitamin B12 deficiency.
• Participant has received liver or any other organ except cornea transplantation.