Ignite Creation Date:
2024-05-05 @ 6:31 PM
Last Modification Date:
2024-10-26 @ 9:33 AM
Study NCT ID:
NCT00490789
Status:
UNKNOWN
Last Update Posted:
2008-04-30
First Post:
2007-06-21
Brief Title:
Trial of Efficacy and Safety of Sirolimus in Tuberous Sclerosis and LAM
Sponsor:
Cardiff University
Organization:
Cardiff University
Study Overview
Official Title:
A Trial of the Efficacy and Safety of SirolimusRapamycinTherapy for Renal Angiomyolipmoas in Patients With Tuberous Sclerosis Complex and Sporadic Lymphangioleiomyomatosis
Status:
UNKNOWN
Status Verified Date:
2008-04
Last Known Status:
ACTIVE_NOT_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
TESSTAL
Brief Summary:
The purpose of this study is to determine the safety and efficacy of the mTOR inhibitor sirolimus as a treatment for renal angiomyolipomas in patients with tyberous sclerosis complex or sporadic lymphangioleiomyomatosis
Detailed Description:
Inherited mutations of the TSC1 or TSC2 gene cause tuberous sclerosis while acquired somatic mutations of either gene are associated with sporadic lymphangioleiomyomatosis LAM Renal angiomyolipomas are a feature of both disorders TSC1 and TSC2 regulate signalling through the mammalian target of rapamycin mTOR pathway Inhibition of mTOR may result in a decrease in size of TSC 12 assciated lesions We are treating patients with tuberous sclerosis or sporadic LAM with the mTOR inhibitor rapamycin in a non-randomised open label pilot study of safety and efficacy Change in size of renal angiomyolipomas is the primary end point
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None