Ignite Creation Date:
2024-05-05 @ 11:24 AM
Last Modification Date:
2024-10-26 @ 9:07 AM
Study NCT ID:
NCT00029731
Status:
COMPLETED
Last Update Posted:
2015-03-25
First Post:
2002-01-21
Brief Title:
Arginine Treatment of Acute Chest Syndrome Pneumonia in Sickle Cell Disease Patients
Sponsor:
UCSF Benioff Childrens Hospital Oakland
Organization:
FDA Office of Orphan Products Development
Study Overview
Official Title:
Arginine Therapy for Acute Chest Syndrome in Sickle Cell Disease
Status:
COMPLETED
Status Verified Date:
2002-01
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:
This is a study to determine if oral arginine will increase nitric oxide in sickle cell disease SCD patients with acute chest syndrome ACS It will also assess the effects of arginine in the body and how the body uses nitric oxide in ACS
Detailed Description:
Pneumonia in patients with SCD can be particularly severe and has come to be called acute chest syndrome ACS is a common cause of morbidity in SCD patients and is the most common cause of death in SCD Multiple factors are involved in the severity of acute pulmonary injury in SCD Nitric oxide has a multitude of related functions many of which could impact favorably on ACS in SCD Nitric oxide is an important inflammatory mediator which is produced by the conversion of L-arginine to citrulline by nitric oxide synthase Nitric oxide and its precursor arginine are known to be low in SCD patients with ACS suggesting that therapies such as arginine aimed at increasing nitric oxide production will improve the clinical course of ACS Patients will receive 1 of 3 doses of arginine hydrochloride orally 3 times a day for 3 days while hospitalized The efficacy of arginine will be measured by the increase in nitric oxide production and the physiological effects will be assessed
Completion date provided represents the completion date of the grant per OOPD records
Completion date provided represents the completion date of the grant per OOPD records
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 |
|---|---|---|---|
| FD-R-001978-01 | None | None | None |