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

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

 No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

 Interventional
Eligible Ages 20 Years - 65 Years
Gender All
More Inclusion & Exclusion Criteria

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 Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

 NCT05252585
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

 Phase 4
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

 Novartis Pharmaceuticals
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

 Novartis Pharmaceuticals
Principal Investigator Affiliation Novartis Pharmaceuticals
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

 Industry
Overall Status Recruiting
Countries Taiwan
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

 Renal Angiomyolipoma
Additional Details

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.

Arms & Interventions

Arms

Experimental: Everolimus

Participants with confirmed diagnosis of TSC-AML and who fulfil the local (Taiwan) reimbursement criteria of everolimus for TSC-AML treatment

Interventions

Drug: - Everolimus

Everolimus tablets for oral use. The recommended everolimus starting dose will be 10 mg orally taken once daily for all patients, except for those with impaired liver function, for whom the everolimus dose will be: Child-Pugh grade A: 7.5 mg once daily (for patients with mild hepatic impairment) Child-Pugh grade B: 5.0 mg once daily (for patients with moderate hepatic impairment)

Contact a Trial Team

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International Sites

Novartis Investigative Site, Taichung, Taiwan ROC, Taiwan

Status

Recruiting

Address

Novartis Investigative Site

Taichung, Taiwan ROC, 40201

Novartis Investigative Site, Taoyuan, Taiwan ROC, Taiwan

Status

Recruiting

Address

Novartis Investigative Site

Taoyuan, Taiwan ROC, 33305

Novartis Investigative Site, Taipei, Taiwan

Status

Recruiting

Address

Novartis Investigative Site

Taipei, , 10002

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