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Arginine Treatment of Acute Chest Syndrome (Pneumonia) in Sickle Cell Disease Patients

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00029731
First Posted: January 22, 2002
Last Update Posted: March 25, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
FDA Office of Orphan Products Development
January 21, 2002
January 22, 2002
March 25, 2015
August 2001
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Complete list of historical versions of study NCT00029731 on ClinicalTrials.gov Archive Site
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Arginine Treatment of Acute Chest Syndrome (Pneumonia) in Sickle Cell Disease Patients
Arginine Therapy for Acute Chest Syndrome in Sickle Cell Disease
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.

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

Interventional
Phase 2
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Primary Purpose: Treatment
  • Anemia, Sickle Cell
  • Pneumonia
Drug: Arginine hydrochloride
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
30
July 2005
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Inclusion criteria:

  • Diagnosis of sickle cell disease (Hb SS, SC, or Sbeta thalassemia)

Acute chest syndrome with the following:

  • New pulmonary infiltrate on chest radiography involving a full segment of the lung and 1 of the following:
  • Fever
  • Cough, tachypnea, retractions, rales, or wheezing
  • Chest pain

Exclusion criteria:

  • Inability to take or tolerate oral medications
  • Hepatic dysfunction (SGPT greater than 2 times normal)
  • Renal dysfunction (creatinine greater than 2 times normal)
  • Mental status or neurological changes
  • Allergy to arginine
  • History of priapism
  • Pregnancy
Sexes Eligible for Study: All
5 Years and older   (Child, Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00029731
FD-R-1978-01
FD-R-001978-01
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Children's Hospital & Research Center Oakland
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FDA Office of Orphan Products Development
January 2002

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP