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Clinical Trial Summary

The purpose of this study was to assess the safety and efficacy of everolimus (Afinitor®) in Chinese patients with renal angiomyolipoma (AML) associated with tuberous sclerosis complex (TSC).


Clinical Trial Description

This was an open label, single arm, multi-center, Phase IV Post-Approval Commitment (PAC) study with once daily oral dose of 10 mg everolimus in participants with renal AML associated with TSC. There were three separate phases in this study: a Screening phase, an Open-label treatment phase where participants received everolimus for 48 weeks or until disease progression, and a Treatment discontinuation follow-up phase for patients who discontinue study drug for reasons other than disease progression. Every participant had an End of Treatment visit within 28 days after last dose and a safety follow-up visit 30 days after last dose. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT03525834
Study type Interventional
Source Novartis
Contact
Status Completed
Phase Phase 4
Start date November 9, 2018
Completion date September 25, 2020

See also
  Status Clinical Trial Phase
Recruiting NCT05252585 - A Phase IV Study of Safety and Efficacy of Everolimus in Taiwanese Patients With Tuberous Sclerosis Complex Who Have Renal Angiomyolipoma (TSC-AML) Phase 4
Not yet recruiting NCT06453642 - Evaluation of a Simple-Prep Controlled Embolic N/A
Terminated NCT02654340 - Biomarkers for Tuberous Sclerosis Complex (BioTuScCom)