Ignite Creation Date:
2024-05-05 @ 12:03 PM
Last Modification Date:
2024-10-26 @ 9:19 AM
Study NCT ID:
NCT00223730
Status:
COMPLETED
Last Update Posted:
2016-11-02
First Post:
2005-09-19
Brief Title:
Chemotherapy Toxicity Reduction Via Urea Cycle Support
Sponsor:
Vanderbilt University
Organization:
Vanderbilt University
Study Overview
Official Title:
Chemotherapy Toxicity Reduction Via Urea Cycle Support
Status:
COMPLETED
Status Verified Date:
2016-11
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:
Patients undergoing bone marrow transplantation BMT and peripheral blood stem cell transplants PBSCT frequently develop organ dysfunctions much of which may be initiated by damage to the liver and to cells lining blood vessels
We the researchers at Vanderbilt University propose to perform a randomized prospective double-blind placebo-controlled study of 144 patients undergoing allogeneic marrow transplantation The treatment is aimed at supporting hepatic urea cycle function in patients receiving escalated dose chemotherapyBMT By so doing we hope to prevent development of hepatic venoocclusive disease HVOD and acute lung injury ALI two morbid complications of BMT Patients will be randomized to receive oral citrulline a urea cycle amino acid intermediate or placebo beginning before conditioning therapy and continuing until 21 days after BMT All patients will be followed for 100 days after study enrollment with intensive data collection
We the researchers at Vanderbilt University propose to perform a randomized prospective double-blind placebo-controlled study of 144 patients undergoing allogeneic marrow transplantation The treatment is aimed at supporting hepatic urea cycle function in patients receiving escalated dose chemotherapyBMT By so doing we hope to prevent development of hepatic venoocclusive disease HVOD and acute lung injury ALI two morbid complications of BMT Patients will be randomized to receive oral citrulline a urea cycle amino acid intermediate or placebo beginning before conditioning therapy and continuing until 21 days after BMT All patients will be followed for 100 days after study enrollment with intensive data collection
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| NIH 1RO1-CA092313-01 | OTHER | NIH | None |
| NIH HL-55198 | OTHER | None | None |
| NIH 1P-30CA68485 | OTHER | None | None |