Ignite Creation Date:
2024-05-05 @ 11:40 AM
Last Modification Date:
2024-10-26 @ 9:11 AM
Study NCT ID:
NCT00105183
Status:
COMPLETED
Last Update Posted:
2012-06-11
First Post:
2005-03-08
Brief Title:
EZ-2053 in the Prophylaxis of Acute Pulmonary Allograft Rejection
Sponsor:
Neovii Biotech
Organization:
Neovii Biotech
Study Overview
Official Title:
A Double-Blind Placebo-Controlled Multicenter Dose-Ranging Study of an Anti-human-T-lymphocyte Immune Globulin EZ-2053 in the Prophylaxis of Acute Pulmonary Allograft Rejection in Adult Recipients of Primary Pulmonary Allografts
Status:
COMPLETED
Status Verified Date:
2012-06
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 is to assess the efficacy and safety of the study drug known as ATG Fresenius S which is sometimes called EZ-2053 to prevent a lung transplant patients body from rejecting a transplanted lung or lungs
Detailed Description:
Patients are generally consented for the study once they go on the lung transplant waiting list and then are re-consented periodically thereafter until they undergo the lung transplant surgery A pre-surgical assessment consisting of medical history physical exam ECG chest X-Ray and blood tests are conducted After lung transplant surgery patients are assessed for continued eligibility Within 6-24 hours after the end of surgery patients are randomized to receive one infusion of study drug or placebo through a central venous catheter Each day for 5 days following transplant surgery patients are monitored for transplant rejection infections adverse events and laboratory test changes On post-randomization Days 14 30 60 90 180 270 and 365 patients will be monitored for acute transplant rejection infections and cancer pulmonary function tests and adverse experiences Pulmonary biopsies will be performed on post-randomization Days 30 60 90 180 and 365 Blood samples will be drawn during each visit
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