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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


Phase 3
5 Years
N/A
Open (Enrolling)
Both
Sickle Cell Anemia, Sickle ß0-Thalassemia

Thank you

Trial Information

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


Inclusion Criteria:



- Patient is at least five years of age.

- Patient has been diagnosed with sickle cell anemia or sickle ß°-thalassemia
(documented by hemoglobin electrophoresis).

- Patient has had at least two documented episodes of sickle cell crises within 12
months of the screening visit.

- If the patient has been treated with an anti-sickling agent within three months of
the screening visit, the therapy must have been continuous for at least three months
with the intent to continue for the duration of the study.

- Patient or the patient's legally authorized representative has given written informed
consent.

- If the patient is a female of child-bearing potential, she agrees to avoid pregnancy
during the study and is willing and agrees to practice a recognized form of birth
control during the course of the study (e.g. barrier, birth control pills,
abstinence).

Exclusion Criteria:

- Patient has a significant medical condition that required hospitalization (other than
sickle cell crisis) within two months of the screening visit.

- Patient has prothrombin time INR > 2.0.

- Patient has serum albumin < 3.0 g/dl.

- Patient has received any blood products within three weeks of the Screening Visit.

- Patient has uncontrolled liver disease or renal insufficiency (refer to Appendix 3
for guidelines).

- Patient is pregnant or lactating or has the intention of becoming pregnant during the
study (if female and of child-bearing potential).

- Patient is currently taking or has been treated with any form of glutamine supplement
within 30 days of the screening visit.

- Patient has been treated with an experimental anti-sickling medication/ treatment
within 30 days of the screening visit (with the exception of hydroxyurea in pediatric
patients).

- Patient is currently taking or has been treated with an investigational drug within
30 days of the screening visit (with the exception of hydroxyurea in pediatric
patients).

- Patient is currently enrolled in an investigational drug or device study and/or has
participated in such a study within 30 days of the screening visit.

- There are factors that would, in the judgment of the investigator, make it difficult
for the patient to comply with the requirements of the study.

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Outcome Measure:

The number of occurrences of sickle cell crises

Outcome Description:

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.

Outcome Time Frame:

48 weeks

Safety Issue:

No

Authority:

United States: Food and Drug Administration

Study ID:

GLUSCC09-01

NCT ID:

NCT01179217

Start Date:

May 2010

Completion Date:

Related Keywords:

  • Sickle Cell Anemia
  • Sickle ß0-Thalassemia
  • Sickle Cell Anemia
  • Sickle Cell Pain Crises
  • Painful Crises
  • Sickle Cell Pain
  • Vaso-occlusive Crises
  • Anemia
  • Anemia, Sickle Cell
  • Thalassemia

Name

Location

Johns Hopkins UniversityBaltimore, Maryland  21205
University of Mississippi Medical CenterJackson, Mississippi  39216-4505
Children's Hospital of MichiganDetroit, Michigan  48201
Children's Hospital of Orange CountyOrange, California  92668
University of South Alabama Medical CenterMobile, Alabama  36604
All Children's HospitalSt. Petersburg, Florida  33701
Cooper University HospitalCamden, New Jersey  08103
University of Tennessee Cancer InstituteMemphis, Tennessee  38103
University of Illinois at ChicagoChicago, Illinois  60612
Brookdale University Hospital and Medical CenterBrooklyn, New York  11212
University of FloridaGainesville, Florida  32610-0277
Kaiser PermanenteSacramento, California  
Virginia Commonwealth UniversityRichmond, Virginia  
Comprehensive Cancer Center of NevadaLas Vegas, Nevada  89109
Children's Mercy Hospitals and ClinicsKansas City, Missouri  64108
Boston University Medical CenterBoston, Massachusetts  02118
Harbor-UCLA Medical CenterTorrance, California  90509
The Brooklyn Hospital CenterBrooklyn, New York  11201
Children's Hospital & Research Center at OaklandOakland, California  94609
Phoenix Children's Hospital Center for Cancer and Blood DisordersPhoenix, Arizona  85016
University of Denver School of Medicine Sickle Cell Treatment & Research CenterAurora, Colorado  80045
Howard University Hospital & Howard UniversityWashington, District of Columbia  20060
Children's Healthcare of Atlanta at Egleston/Emory UniversityAtlanta, Georgia  30322
University of Louisville School of MedicineLouisville, Kentucky  40202
Sickle Cell Center of S. Louisiana, Tulane University School of MedicineNew Orleans, Louisiana  70112
Children's Specialty Center of NevadaLas Vegas, Nevada  89109
Bronx Lebanon HospitalBronx, New York  11203
Interfaith Medical Medical CenterBrooklyn, New York  11238
New York Methodist Hospital - SC/Thalassemia ProgramBrooklyn, New York  11215
SUNY - Downstate Medical CenterBrooklyn, New York  11203
Presbyterian Blume Pediatric Hematology-Oncology ClinicCharlotte, North Carolina  28204