RecruitingPhase 4NCT06940336
To Evaluate the Efficacy and Safety of Tafamidis Meglumine Soft Capsules in the Treatment of Adult Patients With Transthyretin Amyloid Polyneuropathy
A Single Arm, Multicenter, Open-label,Phase IV Clinical Study to Evaluate the Efficacy and Safety of Tafamidis Meglumine Soft Capsules in the Treatment of Adult Patients withTransthyretin Amyloid Polyneuropathy
Sponsor
Qilu Pharmaceutical Co., Ltd.
Enrollment
15 participants
Start Date
Jun 19, 2025
Study Type
INTERVENTIONAL
Conditions
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
Min Age: 18 YearsMax Age: 80 Years
Inclusion Criteria6
- 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 Criteria7
- 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.
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Interventions
DRUGTafamidis Meglumine Soft Capsules
20 mg orally once daily for 72 weeks
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT06940336