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

PHASE4Active, not recruitingINTERVENTIONAL
Enrollment

4

Participants

Timeline

Start Date

May 1, 2023

Primary Completion Date

December 31, 2026

Study Completion Date

December 31, 2026

Conditions
Renal Angiomyolipoma
Interventions
DRUG

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)"

Trial Locations (4)

10002

Novartis Investigative Site, Taipei

33305

Novartis Investigative Site, Taoyuan District

Novartis Investigative Site, Taoyuan District

40201

Novartis Investigative Site, Taichung

Sponsors
All Listed Sponsors
lead

Novartis Pharmaceuticals

INDUSTRY