Status:
COMPLETED
L-Glutamine Therapy for Sickle Cell Anemia and Sickle ß0 Thalassemia
Lead Sponsor:
Emmaus Medical, Inc.
Collaborating Sponsors:
FDA Office of Orphan Products Development
Conditions:
Sickle Cell Anemia
Thalassemia
Eligibility:
All Genders
5+ years
Phase:
PHASE2
Brief Summary
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.
Detailed Description
The primary purpose of this study is to evaluate the effectiveness of oral L-glutamine in the therapy of sickle cell anemia and sickle ß0-thalassemia. The secondary purpose is to assess the effect of...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
March 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2008
Estimated Enrollment :
70 Patients enrolled
Trial Details
Trial ID
NCT00125788
Start Date
March 1 2004
End Date
July 1 2008
Last Update
January 29 2021
Active Locations (5)
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1
Kaiser Permanente
Bellflower, California, United States, 90706
2
Harbor-UCLA Medical Center
Torrance, California, United States, 90502
3
Grady Memorial Hospital
Atlanta, Georgia, United States, 30303
4
University of Medicine and Dentistry, New Jersey
New Brunswick, New Jersey, United States, 08903