Actively Recruiting
To Evaluate the Efficacy and Safety of Tafamidis Meglumine Soft Capsules in the Treatment of Adult Patients With Transthyretin Amyloid Polyneuropathy
Led by Qilu Pharmaceutical Co., Ltd. · Updated on 2025-07-30
15
Participants Needed
1
Research Sites
136 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
CONDITIONS
Official Title
To Evaluate the Efficacy and Safety of Tafamidis Meglumine Soft Capsules in the Treatment of Adult Patients With Transthyretin Amyloid Polyneuropathy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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.
You will not qualify if you...
- 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.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Qilu Hospital of Shandong University
Jinan, China
Actively Recruiting
Research Team
C
chuanzhu yan, Doctor
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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