A PHASE III, PROSPECTIVE, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL-GROUP, MULTICENTER STUDY OF L GLUTAMINE THERAPY FOR SICKLE CELL ANEMIA AND SICKLE ß0-THALASSEMIA
Interventional
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
The number of occurrences of sickle cell crises
The number of occurrences of protocol-defined sickle cell crises that occur from Week 0 to Week 48 will be used to evaluate the efficacy of oral L-glutamine as a treatment for sickle cell anemia and beta-0 thalassemia.
48 weeks
No
United States: Food and Drug Administration
GLUSCC09-01
NCT01179217
May 2010
Name | Location |
---|---|
Johns Hopkins University | Baltimore, Maryland 21205 |
University of Mississippi Medical Center | Jackson, Mississippi 39216-4505 |
Children's Hospital of Michigan | Detroit, Michigan 48201 |
Children's Hospital of Orange County | Orange, California 92668 |
University of South Alabama Medical Center | Mobile, Alabama 36604 |
All Children's Hospital | St. Petersburg, Florida 33701 |
Cooper University Hospital | Camden, New Jersey 08103 |
University of Tennessee Cancer Institute | Memphis, Tennessee 38103 |
University of Illinois at Chicago | Chicago, Illinois 60612 |
Brookdale University Hospital and Medical Center | Brooklyn, New York 11212 |
University of Florida | Gainesville, Florida 32610-0277 |
Kaiser Permanente | Sacramento, California |
Virginia Commonwealth University | Richmond, Virginia |
Comprehensive Cancer Center of Nevada | Las Vegas, Nevada 89109 |
Children's Mercy Hospitals and Clinics | Kansas City, Missouri 64108 |
Boston University Medical Center | Boston, Massachusetts 02118 |
Harbor-UCLA Medical Center | Torrance, California 90509 |
The Brooklyn Hospital Center | Brooklyn, New York 11201 |
Children's Hospital & Research Center at Oakland | Oakland, California 94609 |
Phoenix Children's Hospital Center for Cancer and Blood Disorders | Phoenix, Arizona 85016 |
University of Denver School of Medicine Sickle Cell Treatment & Research Center | Aurora, Colorado 80045 |
Howard University Hospital & Howard University | Washington, District of Columbia 20060 |
Children's Healthcare of Atlanta at Egleston/Emory University | Atlanta, Georgia 30322 |
University of Louisville School of Medicine | Louisville, Kentucky 40202 |
Sickle Cell Center of S. Louisiana, Tulane University School of Medicine | New Orleans, Louisiana 70112 |
Children's Specialty Center of Nevada | Las Vegas, Nevada 89109 |
Bronx Lebanon Hospital | Bronx, New York 11203 |
Interfaith Medical Medical Center | Brooklyn, New York 11238 |
New York Methodist Hospital - SC/Thalassemia Program | Brooklyn, New York 11215 |
SUNY - Downstate Medical Center | Brooklyn, New York 11203 |
Presbyterian Blume Pediatric Hematology-Oncology Clinic | Charlotte, North Carolina 28204 |