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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
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
Details
| Lead sponsor | Qilu Pharmaceutical Co., Ltd. |
|---|---|
| Phase | Phase 4 |
| Status | RECRUITING |
| Enrolment | 15 |
| Start date | 2025-06-19 |
| Completion | 2028-02 |
Conditions
- Transthyretin Amyloid Polyneuropathy
Interventions
- Tafamidis Meglumine Soft Capsules
Primary outcomes
- Change from Baseline Neuropathy Impairment Score-Lower Limb (NIS-LL) at Week 72 — Baseline to 72 Weeks
Change from Baseline Neuropathy Impairment Score-Lower Limb (NIS-LL) at Week 72
Countries
China