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Active Not Recruiting
NCT05252585
A Phase IV Study of Safety and Efficacy of Everolimus in Taiwanese Patients With Tuberous Sclerosis Complex Who Have Renal Angiomyolipoma (TSC-AML)
Conditions: Renal Angiomyolipoma
Sex: All
Ages: 18 Years – 65 Years
Healthy volunteers: No
Phase: PHASE4
Enrollment: 4
Sponsor: Novartis Pharmaceuticals
Location: Novartis Investigative Site Taichung Taiwan ROC
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 Criteria
Inclusion Criteria:
1. Adult male or female patients from ≥ 18 years of age.
2. Signed informed consent must be obtained prior to participation in the study.
3. Participants with TSC associated with renal AML which is eligible for treatment with everolimus per local reimbursement criteria.
Exclusion Criteria:
1. Patients with severe hepatic impairment (Child-Pugh class C)
2. Any severe and/or uncontrolled medical conditions.
3. Pregnant or breast-feeding females.
4. Patients with hypersensitivity to the active substance, to other rapamycin derivatives, or to any of the excipients.
Source: ClinicalTrials.gov (NCT05252585). StuddyBuddy aggregates publicly available trial information.
