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

RecruitingPhase 4Ages 18 Years - 80 YearsAllQilu Pharmaceutical Co., Ltd.
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In plain words

What the trial is, and whether it could suit you

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

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
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 โ‰ฅ50. * 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.
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What it tests

  • Tafamidis Meglumine Soft Capsules
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Where

1 site
Qilu Hospital of Shandong University
Jinan, China
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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