NCT05252585CompletedPhase 4
A Phase IV Study of Safety and Efficacy of Everolimus in Taiwanese Patients With Tuberous Sclerosis Complex Who Have Renal Angiomyolipoma (TSC-AML)
Phase IV, Prospective Single Arm Study of Safety and Efficacy of Votubia (Everolimus) in Taiwanese Adults With Tuberous Sclerosis Complex Who Have Renal Angiomyolipoma
Source: ClinicalTrials.gov · Last updated 29 Oct 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 4 (actual)
- First submitted
- 16 Feb 2022
- Start date
- May 2023
- Primary completion date
- Oct 2026
- Lead sponsor
- Novartis Pharmaceuticals
- NCT number
- NCT05252585
What you commit to
- Study type: Interventional · Phase 4
- Participants enrolled: 4
- From May 2023 to the primary completion date, Oct 2026
- 3 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Patients with severe hepatic impairment (Child-Pugh class C)
- Any severe and/or uncontrolled medical conditions.
- Patients with hypersensitivity to the active substance, to other rapamycin derivatives, or to any of the excipients.
Other
- Pregnant or breast-feeding females.
Who the study is looking for
- 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.
Age in the registry: 18 years to 65 years · Sex: All · Does not accept healthy volunteers
Sites (3)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| - Coordinator of this site? Confirm its status | Taichung | Taiwan | Unknown status |
| - Coordinator of this site? Confirm its status | Taipei | Taiwan | Unknown status |
| - Coordinator of this site? Confirm its status | Taoyuan | Taiwan | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.