Status:
ACTIVE_NOT_RECRUITING
A Phase IV Study of Safety and Efficacy of Everolimus in Taiwanese Patients With Tuberous Sclerosis Complex Who Have Renal Angiomyolipoma (TSC-AML)
Lead Sponsor:
Novartis Pharmaceuticals
Conditions:
Renal Angiomyolipoma
Eligibility:
All Genders
18-65 years
Phase:
PHASE4
Brief 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 p...
Detailed Description
This open-label, prospective, single-arm, multicenter Phase IV post approval commitment (PAC) study is planned to be conducted in approximately 10 patients with confirmed diagnosis of TSC-AML and who ...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- Patients with severe hepatic impairment (Child-Pugh class C)
- Any severe and/or uncontrolled medical conditions.
- Pregnant or breast-feeding females.
- Patients with hypersensitivity to the active substance, to other rapamycin derivatives, or to any of the excipients.
Key Trial Info
Start Date :
May 1 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 31 2026
Estimated Enrollment :
4 Patients enrolled
Trial Details
Trial ID
NCT05252585
Start Date
May 1 2023
End Date
December 31 2026
Last Update
October 20 2025
Active Locations (4)
Enter a location and click search to find clinical trials sorted by distance.
1
Novartis Investigative Site
Taichung, Taiwan ROC, Taiwan, 40201
2
Novartis Investigative Site
Taoyuan District, Taiwan ROC, Taiwan, 33305
3
Novartis Investigative Site
Taipei, Taiwan, 10002
4
Novartis Investigative Site
Taoyuan District, Taiwan, 33305