Ignite Creation Date:
2024-05-05 @ 11:25 AM
Last Modification Date:
2024-10-26 @ 9:07 AM
Study NCT ID:
NCT00037531
Status:
COMPLETED
Last Update Posted:
2009-08-18
First Post:
2002-05-17
Brief Title:
Study Evaluating Sirolimus Rapamune in Solid Organ Transplant Recipients
Sponsor:
Wyeth is now a wholly owned subsidiary of Pfizer
Organization:
Wyeth is now a wholly owned subsidiary of Pfizer
Study Overview
Official Title:
An Open-label Extension Study of the Safety of Long-term Administration of Sirolimus Rapamune in Solid Organ Transplant Recipients
Status:
COMPLETED
Status Verified Date:
2009-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
To evaluate the safety of long-term administration of sirolimus oral solution for up to 5 additional years or until the tablet formulation is commercially available whichever occurs first in solid organ transplant recipients who are currently receiving sirolimus and who have completed clinical trials with sirolimus with or without cyclosporine CsA To evaluate the pharmacokinetics and safety of long-term administration of sirolimus tablets administered for up to 5 years or until the tablet formulation is commercially available in solid organ transplant recipients who are currently receiving sirolimus and who have completed clinical trials with sirolimus with or without CsA or who are currently enrolled in protocol 0468E1-306-US
Detailed Description:
None
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