A Phase III Safety and Efficacy Study of L-Glutamine to Treat Sickle Cell Disease or Sickle βo-thalassemia
Recruiting in Palo Alto (17 mi)
+30 other locations
Age: Any Age
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 3
Waitlist Available
Sponsor: Emmaus Medical, Inc.
Pivotal Trial (Near Approval)
Prior Safety Data
Trial Summary
What is the purpose of this trial?
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.
Research Team
YN
Yutaka Niihara, MD, MPH
Principal Investigator
Chairman and CEO
Eligibility Criteria
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.
See 3 more
Treatment Details
Interventions
- L-glutamine (Amino Acid)
- Placebo (Other)
Participant Groups
2Treatment groups
Experimental Treatment
Placebo Group
Group I: L-glutamineExperimental Treatment1 Intervention
Patients will be randomized to receive investigational product, L-Glutamine.
Group II: 100% maltodextrinPlacebo Group1 Intervention
Patients will be randomized to receive Placebo.
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Children's Healthcare of Atlanta at Egleston/Emory UniversityAtlanta, GA
University of Tennessee Cancer InstituteMemphis, TN
Johns Hopkins UniversityBaltimore, MD
Children's Hospital of MichiganDetroit, MI
More Trial Locations
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Who Is Running the Clinical Trial?
Emmaus Medical, Inc.
Lead Sponsor
Trials
8
Patients Recruited
380+