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Clinical Trials in China / NCT06940336
Recruiting Phase 4

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

NCT06940336 · tracked via the Priya Life Science China tracker
Sponsor
Qilu Pharmaceutical Co., Ltd.
Phase
Phase 4
Started
2025-06-19
Last updated
2025-07-30

Condition(s) studied

Transthyretin Amyloid Polyneuropathy

Investigational drug(s) / intervention(s)

Tafamidis Meglumine Soft Capsules

Tafamidis Meglumine Soft Capsules: 20 mg orally once daily for 72 weeks

Study 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

Sex
ALL
Min age
18 Years
Max age
80 Years
Healthy volunteers
No
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.

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Qilu Hospital of Shandong University Jinan China Recruiting

More Qilu Pharmaceutical Co., Ltd. trials in China

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06940336 on ClinicalTrials.gov ↗ ← All trials in China