The primary purpose of this study is to evaluate the effectiveness of oral L-glutamine in therapy of Sickle Cell Anemia and Sickle ß0-Thalassemia.

The secondary purpose is to assess the effect of L-glutamine on pain, energy, and appetite levels, narcotics usage, height and weight, and hospital and emergency room visits for sickle cell pain.

Condition	Intervention	Phase
Sickle Cell Anemia (homozygous) Sickle ß0-Thalassemia	Drug: L-glutamine	Phase II

Further Study Details: 

Primary Outcomes: Number of occurrences of painful sickle cell crises
Secondary Outcomes: Frequency of hospitalizations for sickle cell pain; Frequency of emergency room visits for sickle cell pain; Number of days patients’ usual daily activities are interrupted due to sickle cell pain; Height and weight; Growth curve for patients less than 18 years of age; Hematological parameters; Narcotic usage; Alcohol and tobacco use; Pain level; Energy level; Patient activity level; Patient appetite; Subjective exercise tolerance; Subjective quality of life; L-glutaime safety assessment based on adverse events, laboratory parameters, and vital signs
Expected Total Enrollment:  80

Ages Eligible for Study:  5 Years and above,  Genders Eligible for Study:  Both

Criteria

INCLUSION CRITERIA:

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 ß°-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.

EXCLUSION CRITERIA::

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 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.

Please refer to this study by ClinicalTrials.gov identifier  NCT00125788

Sarah L McGovern, BS      (949) 428-6625    sarah.mcgovern@clindatrix.com

California
      Harbor-UCLA Medical Center, Torrance,  California,  90502,  United States; Recruiting
      Kaiser Permanente, Bellflower,  California,  90706,  United States; Recruiting
Georgia
      Emory University Hospital, Atlanta,  Georgia,  30322,  United States; Not yet recruiting
New Jersey
      University of Medicine and Dentristry, New Jersey, New Brunswick,  New Jersey,  08903,  United States; Recruiting
New York
      Jacobi Medical Center, Bronx,  New York,  10461,  United States; Recruiting

Study chairs or principal investigators

Yutaka Niihara, MD,  Principal Investigator,  CEO, Emmaus Medical, Inc   

Study ID Numbers:  10478
Last Updated:  August 1, 2005
Record first received:  August 1, 2005
ClinicalTrials.gov Identifier:  NCT00125788
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-08-02