ClinicalTrials.Veeva

Menu

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

Novartis logo

Novartis

Status and phase

Enrolling
Phase 4

Conditions

Renal Angiomyolipoma

Treatments

Drug: Everolimus

Study type

Interventional

Funder types

Industry

Identifiers

NCT05252585
CRAD001M2402

Details and patient eligibility

About

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.

Full 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 fulfil the local reimbursement criteria of everolimus for TSC-AML treatment.

The study will have a 30-day screening phase, and each patient will be on treatment up to 52 weeks. Enrollment will end at the latest within 52 weeks from Day 1 of the study, regardless of the number of patients actually recruited. After completion of the treatment phase/end of treatment (EOT), eligible patients will enter a 4-week safety follow up (FU) phase. Patients who continue to be on treatment beyond 52 weeks, based on the investigator's judgment will not be included in the 4-week safety FU phase.

Enrollment

10 estimated patients

Sex

All

Ages

20 to 65 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  1. Male or female patients from ≥ 20 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. Prior therapy with systemic mTOR inhibitors (sirolimus, temsirolimus, everolimus).
  3. Any severe and/or uncontrolled medical conditions.
  4. Pregnant or breast-feeding females.
  5. Patients with hypersensitivity to the active substance, to other rapamycin derivatives, or to any of the excipients.

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

10 participants in 1 patient group

Everolimus
Experimental group
Description:
Participants with confirmed diagnosis of TSC-AML and who fulfil the local (Taiwan) reimbursement criteria of everolimus for TSC-AML treatment
Treatment:
Drug: Everolimus

Trial contacts and locations

3

Loading...

Central trial contact

Novartis Pharmaceuticals; Novartis Pharmaceuticals

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2024 Veeva Systems