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NCT01179217 · ClinicalTrials.gov registry record · Phase 3
A Phase III Safety and Efficacy Study of L-Glutamine to Treat Sickle Cell Disease or Sickle βo-thalassemia
A Phase 3 study, sponsored by Emmaus Medical.
- Completed
- Registry status
- Phase 3
- Development phase
- 230
- Enrollment target
NCT01179217: Completed Phase 3 study, sponsored by Emmaus Medical.
NCT01179217 is a Phase 3 study that has completed, run by Emmaus Medical. The registered enrollment target is 230 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (70% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01179217, a Phase 3 study, has completed, sponsored by Emmaus Medical.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 230 participants
- Enrollment target
Study Summary
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.
Primary Outcome
The number of occurrences of protocol-defined sickle cell crises that occur from Week 0 to Week 48 will be used to evaluate the efficacy of oral L-glutamine as a treatment for sickle cell anemia and beta-0 thalassemia.
Interventions
- DRUG Placebo
- DRUG L-glutamine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 230 participants |
| Start Date | 2010-05 |
| Est. Completion | 2014-03 |
| Phase | Phase 3 |
What the finished NCT01179217 record still lists
NCT01179217 is an interventional study that assigns participants to a tested intervention. The registered 230 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (70% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT01179217 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01179217 about?
NCT01179217 is a clinical study titled "A Phase III Safety and Efficacy Study of L-Glutamine to Treat Sickle Cell Disease or Sickle βo-thalassemia". 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.
What is the current status of trial NCT01179217?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 230 participants. The study started on 2010-05. Estimated completion is 2014-03.
What interventions are being tested in trial NCT01179217?
The interventions under investigation include: Placebo (DRUG), L-glutamine (DRUG).
Who is sponsoring clinical trial NCT01179217?
This trial is sponsored by Emmaus Medical, which has 4 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01179217's enrollment target sits among peer trials
230 1304th of 2000 higher than 692 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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