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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
  Purpose
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.

Condition Intervention Phase
Anemia, Sickle Cell Pneumonia Drug: Arginine hydrochloride Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Primary Purpose: Treatment
Official Title: Arginine Therapy for Acute Chest Syndrome in Sickle Cell Disease

Resource links provided by NLM:


Further study details as provided by FDA Office of Orphan Products Development:

Estimated Enrollment: 30
Study Start Date: August 2001
Estimated Study Completion Date: July 2005
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

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   5 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00029731


Locations
United States, California
Children's Hospital Oakland
Oakland, California, United States, 94609
Sponsors and Collaborators
Children's Hospital & Research Center Oakland
  More Information

ClinicalTrials.gov Identifier: NCT00029731     History of Changes
Other Study ID Numbers: FD-R-1978-01
FD-R-001978-01
First Submitted: January 21, 2002
First Posted: January 22, 2002
Last Update Posted: March 25, 2015
Last Verified: January 2002

Keywords provided by FDA Office of Orphan Products Development:
Nitric Oxide
Administration, Oral

Additional relevant MeSH terms:
Pneumonia
Anemia, Sickle Cell
Acute Chest Syndrome
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Anemia, Hemolytic, Congenital
Anemia, Hemolytic
Anemia
Hematologic Diseases
Hemoglobinopathies
Genetic Diseases, Inborn
Respiration Disorders