Phase IV, Prospective Single Arm Study of Safety and Efficacy of Votubia (Everolimus) in Taiwanese Adults With Tuberous Sclerosis Complex Who Have Renal Angiomyolipoma
Who is this study for? Taiwanese adults with tuberous sclerosis complex who have renal angiomyolipoma
What treatments are being studied? Everolimus
Status: Recruiting
Location: See all (4) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 4
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 65
Healthy Volunteers: f
View:
• Adult male or female patients from ≥ 18 years of age.
• Signed informed consent must be obtained prior to participation in the study.
• Participants with TSC associated with renal AML which is eligible for treatment with everolimus per local reimbursement criteria.
Locations
Other Locations
Taiwan
Novartis Investigative Site
RECRUITING
Taichung
Novartis Investigative Site
RECRUITING
Taipei
Novartis Investigative Site
RECRUITING
Taoyuan District
Novartis Investigative Site
RECRUITING
Taoyuan District
Contact Information
Primary
Novartis Pharmaceuticals
novartis.email@novartis.com
+41613241111
Backup
Novartis Pharmaceuticals
Time Frame
Start Date: 2023-05-01
Estimated Completion Date: 2026-12-31
Participants
Target number of participants: 10
Treatments
Experimental: Everolimus
Participants with confirmed diagnosis of TSC-AML and who fulfil the local (Taiwan) reimbursement criteria of everolimus for TSC-AML treatment
Related Therapeutic Areas
Sponsors
Leads: Novartis Pharmaceuticals