L-Glutamine Therapy for Sickle Cell Anemia and Sickle ß0 Thalassemia

Completed · Phase 2 · Has a placebo group

Conditions studied: Sickle Cell Anemia, Thalassemia

In brief

The purpose of this research is to evaluate the effects of L-glutamine as a therapy for sickle cell anemia and sickle ß0-thalassemia. as evaluated by the number of occurrences of sickle cell crises.

Key facts

Study ID

NCT00125788

Run by

Emmaus Medical, Inc.

People needed

70

Starts

2004-03-01

Expected to finish

2008-07-01

Last updated by the study team

2021-01-29

Who can join

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

You may qualify if…

• To be eligible to participate in the study, a patient must meet all of the following inclusion criteria:
• Patient is at least five years of age.
• Patient has been diagnosed with sickle cell anemia or sickle ß0-thalassemia (documented by hemoglobin electrophoresis).
• Patient has had at least two episodes of painful 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 next 14 months.
• 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 practice a recognized form of birth control during the course of the study.

You may not qualify if…

• If the patient meets any of the following criteria, the patient must not be enrolled:
• Patient has a significant medical condition that required hospitalization (other than sickle painful crisis) within two months of the screening visit.
• Patient has diabetes mellitus with untreated fasting blood sugar >115 mg/dL.
• Patient has prothrombin time International Normalized Ratio (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 a history of uncontrolled liver disease or renal insufficiency.
• Patient is pregnant or lactating.
• Patient has been treated with an experimental anti-sickling medication/treatment (except hydroxyurea) within 30 days of the screening visit.
• Patient has been treated with an experimental drug 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

• Kaiser Permanente — Bellflower, California, United States
• Harbor-UCLA Medical Center — Torrance, California, United States
• Grady Memorial Hospital — Atlanta, Georgia, United States
• University of Medicine and Dentistry, New Jersey — New Brunswick, New Jersey, United States
• Jacobi Medical Center — The Bronx, New York, United States

Full record on ClinicalTrials.gov

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