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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tafamidis Meglumine Soft Capsules | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tafamidis Meglumine Soft Capsules | Drug | 20 mg orally once daily for 72 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change from Baseline Neuropathy Impairment Score-Lower Limb (NIS-LL) at Week 72 | Change from Baseline Neuropathy Impairment Score-Lower Limb (NIS-LL) at Week 72 | Baseline to 72 Weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change from Baseline NIS-LL at Week 24 and Week 48 | Change from Baseline NIS-LL at Week 24 and Week 48 | Baseline to 24 and 48 Weeks |
| Change from Baseline Modified Body Mass Index(mBMI) at Week 4, Week 8, Week 12,Week 24, Week 36,Week 48 and Week 72 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| chuanzhu yan, Doctor | Contact | 18560082288 | zzl2002@medmail.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Qilu Hospital of Shandong University | Recruiting | Jinan | China |
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Change from Baseline Modified Body Mass Index(mBMI) at Week 4, Week 8, Week 12,Week 24, Week 36,Week 48 and Week 72
| Baseline to 4, 8, 12, 24, 36, 48 and 72 Weeks |
| ID | Term |
|---|---|
| D028227 | Amyloid Neuropathies, Familial |
| ID | Term |
|---|---|
| D020271 | Heredodegenerative Disorders, Nervous System |
| D019636 | Neurodegenerative Diseases |
| D009422 | Nervous System Diseases |
| D017772 | Amyloid Neuropathies |
| D010523 | Peripheral Nervous System Diseases |
| D009468 | Neuromuscular Diseases |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D028226 | Amyloidosis, Familial |
| D008661 | Metabolism, Inborn Errors |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D000686 | Amyloidosis |
| D057165 | Proteostasis Deficiencies |
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