Active — Not RecruitingPhase 4

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

Taiwan4 participantsStarted 2023-05-01

Plain-language 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.

Who can participate

Age range18 Years – 65 Years

SexALL

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Inclusion criteria

✓. 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 criteria

✕. 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.

What they're measuring

Percentage of participants with adverse events (AEs), Serious AEs (SAEs) and AEs of special interest (AESI)

Timeframe: From first dose of study treatment up to 56 weeks

Trial details

NCT IDNCT05252585

SponsorNovartis Pharmaceuticals

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2026-10-10

View on ClinicalTrials.gov More Renal Angiomyolipoma trials