A Phase III Safety and Efficacy Study of L-Glutamine to Treat Sickle Cell Disease or Sickle βo-thalassemia

Completed · Phase 3 · Has a placebo group

Conditions studied: Sickle Cell Anemia, Sickle ß0-Thalassemia

In brief

The purpose of this research is to evaluate the effects of L-glutamine as a therapy for Sickle Cell Anemia or Sickle ß0 Thalassemia as evaluated by the number of occurrences of sickle cell crises.

Key facts

Study ID: NCT01179217
Run by: Emmaus Medical, Inc.
People needed: 230
Starts: 2010-05-01
Expected to finish: 2014-03-01
Last updated by the study team: 2020-08-19

Who can join

Age: 5 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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).

You may not qualify if…

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.
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.

Where it is running

University of South Alabama Medical Center — Mobile, Alabama, United States
Phoenix Children's Hospital Center for Cancer and Blood Disorders — Phoenix, Arizona, United States
Kaiser Permanente — Inglewood, California, United States
Children's Hospital & Research Center at Oakland — Oakland, California, United States
Children's Hospital of Orange County — Orange, California, United States
Harbor-UCLA Medical Center — Torrance, California, United States
University of Denver School of Medicine Sickle Cell Treatment & Research Center — Aurora, Colorado, United States
Howard University Hospital & Howard University — Washington D.C., District of Columbia, United States
University of Florida — Gainesville, Florida, United States
All Children's Hospital — St. Petersburg, Florida, United States
Children's Healthcare of Atlanta at Egleston/Emory University — Atlanta, Georgia, United States
University of Illinois at Chicago — Chicago, Illinois, United States
University of Louisville School of Medicine — Louisville, Kentucky, United States
Sickle Cell Center of S. Louisiana, Tulane University School of Medicine — New Orleans, Louisiana, United States
Johns Hopkins University — Baltimore, Maryland, United States
Boston University Medical Center — Boston, Massachusetts, United States
Children's Hospital of Michigan — Detroit, Michigan, United States
University of Mississippi Medical Center — Jackson, Mississippi, United States
Children's Mercy Hospitals and Clinics — Kansas City, Missouri, United States
Children's Specialty Center of Nevada — Las Vegas, Nevada, United States
Comprehensive Cancer Center of Nevada — Las Vegas, Nevada, United States
Cooper University Hospital — Camden, New Jersey, United States
The Brooklyn Hospital Center — Brooklyn, New York, United States
SUNY - Downstate Medical Center — Brooklyn, New York, United States
Brookdale University Hospital and Medical Center — Brooklyn, New York, United States

Full record on ClinicalTrials.gov

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