Ignite Creation Date:
2024-05-05 @ 5:25 PM
Last Modification Date:
2024-10-26 @ 9:32 AM
Study NCT ID:
NCT00457808
Status:
COMPLETED
Last Update Posted:
2007-04-09
First Post:
2007-04-06
Brief Title:
Rapamycin Therapy for Patients With Tuberous Sclerosis Complex and Sporadic LAM
Sponsor:
Childrens Hospital Medical Center Cincinnati
Organization:
Childrens Hospital Medical Center Cincinnati
Study Overview
Official Title:
Rapamycin Therapy of Angiomyolipomas in Patients With Tuberous Sclerosis Complex and Sporadic Lymphangioleiomyomatosis
Status:
COMPLETED
Status Verified Date:
2007-04
Last Known Status:
None
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:
None
Brief Summary:
The purpose of this study was to determine if rapamycin reduced angiomyolipomata volume in patients with tuberous sclerosis complex or lam
Detailed Description:
The study design was an open label phase III trial of sirolimus for one year followed by one year off therapyPatients were seen at baselineat two weeks to four weeks and at 24691218 and 24 months Angiomyolipomata imaging was performed at all but the two to four week visit Complete pulmonary function tests and six-minute walk were obtained at baseline6 or 9 month 12 and 24 month visits while simple spirometry only was performed at all other visits
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| R21CA103486 | NIH | None | httpsreporternihgovquickSearchR21CA103486 |