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

Launched by NOVARTIS PHARMACEUTICALS · Feb 16, 2022

Keywords

ClinConnect Summary

This clinical trial is studying the safety and effectiveness of a medication called everolimus in Taiwanese patients who have a specific condition known as renal angiomyolipoma (AML) associated with tuberous sclerosis complex (TSC). Essentially, the researchers want to see if everolimus can help manage this condition, which affects the kidneys and can cause tumors. Only patients who meet certain local guidelines for treatment with everolimus are being included in the study.

To participate in this trial, individuals must be at least 18 years old and provide their consent to join. They should have TSC with renal AML that qualifies for treatment with everolimus. However, people with severe liver problems, uncontrolled medical conditions, pregnant or breastfeeding women, and those who have allergies to the medication or similar drugs cannot participate. If eligible, participants can expect to be monitored for their health and response to the treatment throughout the study. This trial is currently recruiting participants, and it represents an important step in understanding how to better treat this condition.

Gender

ALL

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.