drugset
drugset / Trial / NCT05252585

A Phase IV Study of Safety and Efficacy of Everolimus in Taiwanese Patients With Tuberous Sclerosis Complex Who Have Renal Angiomyolipoma (TSC-AML)

NCT05252585 ↗

Phase 4 Active not recruiting 4 enrolled Novartis Pharmaceuticals
NaSingle-groupOpen-labelTreatment

Summary

The purpose of this prospective study is to assess the safety and efficacy of everolimus in Taiwanese patients with renal angiomyolipoma (AML) associated with tuberous sclerosis complex (TSC) . Only patients who fulfil the local reimbursement criteria of everolimus for TSC-AML will be included in this study.

Timeline

Start
2023-05-01
Primary completion
2026-10-10
Completion
2026-10-10

Drugs

EvaluationDrugModalityDoseRoute
Subject Everolimus Small molecule 5 mg Oral
Subject Everolimus Small molecule 7.5 mg Oral
Subject Everolimus Small molecule 10 mg Oral

Indications

kidney angiomyolipoma