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A Phase IV Study of Safety and Efficacy of Everolimus in Taiwanese Patients With Tuberous Sclerosis Complex Who Have Renal Angiomyolipoma (TSC-AML)
Sponsor: Novartis Pharmaceuticals
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.
Official title: Phase IV, Prospective Single Arm Study of Safety and Efficacy of Votubia (Everolimus) in Taiwanese Adults With Tuberous Sclerosis Complex Who Have Renal Angiomyolipoma
Key Details
Gender
All
Age Range
18 Years - 65 Years
Study Type
INTERVENTIONAL
Enrollment
4
Start Date
2023-05-01
Completion Date
2026-10-10
Last Updated
2026-04-02
Healthy Volunteers
No
Conditions
Interventions
Everolimus
Everolimus tablets for oral use. The recommended everolimus starting dose will be 10 mg orally taken once daily for all patients, except for those with impaired liver function, for whom the everolimus dose will be: * Child-Pugh grade A: 7.5 mg once daily (for patients with mild hepatic impairment) * Child-Pugh grade B: 5.0 mg once daily (for patients with moderate hepatic impairment)
Locations (4)
Novartis Investigative Site
Taichung, Taiwan ROC, Taiwan
Novartis Investigative Site
Taoyuan District, Taiwan ROC, Taiwan
Novartis Investigative Site
Taipei, Taiwan
Novartis Investigative Site
Taoyuan District, Taiwan