At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 70 enrolled
Drug / intervention
L-glutamine +1 moredrug
Likely dose
L-glutamine 0.3 g/kg total daily dose orally (over two doses), maximum 30 grams dailyAI-extracted
Key inclusion· 4
- ✓Age at least 5 years
- ✓Confirmed sickle cell anemia or sickle β0-thalassemia by hemoglobin electrophoresis
- ✓At least 2 painful crises in the 12 months before screening
- ✓If on prior anti-sickling agent, must have been continuous for ≥3 months with intent to continue ≥14 months
Key exclusion· 8
- ✕Hospitalization (other than sickle pain crisis) within 2 months of screening
- ✕Uncontrolled diabetes with fasting blood sugar >115 mg/dL
- ✕Prothrombin time INR >2.0
- ✕Serum albumin <3.0 g/dL
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase II, Prospective, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multicenter Study of L Glutamine Therapy for Sickle Cell Anemia and Sickle ß0-Thalassemia
In Brief
A Phase 2 clinical trial evaluating L-glutamine and Placebo for Sickle Cell Anemia and Thalassemia. Completed, enrolled 70 participants across 5 sites.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsSickle Cell Anemia, Thalassemia
CountriesUnited States
CollaboratorsFDA Office of Orphan Products Development
Timeline
Phase 2CompletedFinished
200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartMar 2004
First PostedAug 2005
Primary CompletionJul 2008
TodayJul 2026
First PostedAug 2, 2005
Enrollment StartMar 1, 2004
Primary CompletionJul 1, 2008
TodayJul 2, 2026
Enrollment to primary: 4.3 yearsPosted 20.9 years ago
Interventions
L-glutaminedrug
Approximately 0.3 g/kg total daily dose of L-glutamine will be orally administered (over two doses), with a maximum total daily dose of 30 grams.
Placebodrug
Approximately 0.3 g/kg total daily dose of maltodextrin placebo will be orally administered (over two doses), with a maximum total daily dose of 30 grams.