Trial · NCT01179217

A Phase III Safety and Efficacy Study of L-Glutamine to Treat Sickle Cell Disease or Sickle βo-thalassemia

NCT01179217, Phase 3, Completed, Emmaus Medical, Inc.; results first posted 2017-08-10

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. A Phase III Safety and Efficacy Study of L-Glutamine to Treat Sickle Cell Disease or Sickle βo-thalassemia. Trials, record NCT01179217. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01179217

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: A Phase III Safety and Efficacy Study of L-Glutamine to Treat Sickle Cell Disease or Sickle βo-thalassemia
NCT number: NCT01179217
Status: Completed
Phases: Phase 3
Enrollment: 230 participants, actual
Lead sponsor: Emmaus Medical, Inc.
Conditions: Sickle Cell Anemia, Sickle ß0-Thalassemia
Interventions: L-glutamine, Placebo
First posted: 2010-08-11
Last updated: 2020-08-19
Results first posted: 2017-08-10

Source ClinicalTrials.gov

Registered outcomes10

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	The Number of Occurrences of Sickle Cell Crises	48 weeks	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.
Secondary	The Number of Hospitalizations for Sickle Cell Pain	48 weeks	The number of hospitalizations 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.
Secondary	The Number of Emergency Room/Medical Facility Visits for Sickle Cell Pain	48 weeks	The number of emergency room visits or medical facility visits 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.
Secondary	The Effect of Oral -L-glutamine on Hematological Parameters	Baseline, Week 4, 24 and 48	To assess the effect of oral L-glutamine on hematological parameters (hemoglobin), Change from Baseline will be reported at Weeks 4, 24 and 48.
Secondary	The Effect of Oral L-glutamine on Vital Signs	Baseline, Week 4, 24, and 48	To assess the effect of oral L-glutamine on Vital signs (systolic and diastolic blood pressure). Change from Baseline will be reported at Weeks 4, 24, and 48.
Secondary	The Effect of Oral L-glutamine on Hematological Parameters	Baseline, Week 4, 24 and 48	To assess the effect of oral L-glutamine on hematological parameters (hematocrit), Change from Baseline will be reported at Weeks 4, 24 and 48.
Secondary	The Effect of Oral L-glutamine on Hematological Parameters	Baseline, Week 4, 24 and 48	To assess the effect of oral L-glutamine on hematological parameters (reticulocyte count), Change from Baseline will be reported at Weeks 4, 24 and 48.
Secondary	The Effect of Oral L-glutamine on Vital Signs	Baseline, Week 4, Week 24 and Week 48	To assess the effect of oral L-glutamine on Vital signs (pulse rate). Change from Baseline will be reported at Weeks 4, 24, and 48.
Secondary	Effect of Oral L-glutamine on Vital Signs	Baseline, Week 4, Week 24 and Week 48	To assess the effect of oral L-glutamine on Vital signs (temperature). Change from Baseline will be reported at Weeks 4, 24, and 48.
Secondary	The Effect of Oral L-glutamine on Vital Signs	Baseline, Week 4, Week 24 and Week 48	To assess the effect of oral L-glutamine on Vital signs (respiration). Change from Baseline will be reported at Weeks 4, 24, and 48.

Source ClinicalTrials.gov

Outcomes10

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	The Number of Occurrences of Sickle Cell Crises	48 weeks	Intent-to-Treat Population - Included all patients who were randomized and dispensed study medication.	Number of crises	MEDIAN
SECONDARY	The Number of Hospitalizations for Sickle Cell Pain	48 weeks	Intent-to-Treat Population - Included all patients who were randomized and dispensed study medication.	Number of hospitalizations	MEDIAN
SECONDARY	The Number of Emergency Room/Medical Facility Visits for Sickle Cell Pain	48 weeks	Intent-to-Treat Population - Included all patients who were randomized and dispensed study medication.	Number of ER visits	MEDIAN
SECONDARY	The Effect of Oral -L-glutamine on Hematological Parameters	Baseline, Week 4, 24 and 48	Safety population - The safety population included all patients who received at least 1 dose of study medication.	g/dL	MEAN
SECONDARY	The Effect of Oral L-glutamine on Vital Signs	Baseline, Week 4, 24, and 48	Safety Population which includes all patients that took at least one dose of study medication.	mm Hg	MEAN
SECONDARY	The Effect of Oral L-glutamine on Hematological Parameters	Baseline, Week 4, 24 and 48	Safety population - The safety population included all patients who received at least 1 dose of study medication.	% of red blood cells	MEAN
SECONDARY	The Effect of Oral L-glutamine on Hematological Parameters	Baseline, Week 4, 24 and 48	Safety population - The safety population included all patients who received at least 1 dose of study medication.	1000 cells/uL	MEAN
SECONDARY	The Effect of Oral L-glutamine on Vital Signs	Baseline, Week 4, Week 24 and Week 48	Safety Population which includes all patients that took at least one dose of study medication.	bpm	MEAN
SECONDARY	Effect of Oral L-glutamine on Vital Signs	Baseline, Week 4, Week 24 and Week 48	Safety Population which includes all patients that took at least one dose of study medication.	degree C	MEAN
SECONDARY	The Effect of Oral L-glutamine on Vital Signs	Baseline, Week 4, Week 24 and Week 48	Safety Population which includes all patients that took at least one dose of study medication.	breaths/min	MEAN

Source ClinicalTrials.gov

Results by group70

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Category	Value	Spread	Units
The Number of Occurrences of Sickle Cell Crises	L-glutamine		3	Full Range 0 to 15	Number of crises
The Number of Occurrences of Sickle Cell Crises	100% Maltodextrin		4	Full Range 0 to 15	Number of crises
The Number of Hospitalizations for Sickle Cell Pain	L-glutamine		2	Full Range 0 to 14	Number of hospitalizations
The Number of Hospitalizations for Sickle Cell Pain	100% Maltodextrin		3	Full Range 0 to 13	Number of hospitalizations
The Number of Emergency Room/Medical Facility Visits for Sickle Cell Pain	L-glutamine		1	Full Range 0 to 12	Number of ER visits
The Number of Emergency Room/Medical Facility Visits for Sickle Cell Pain	100% Maltodextrin		1	Full Range 0 to 15	Number of ER visits
The Effect of Oral -L-glutamine on Hematological Parameters	L-glutamine	Hemoglobin at Baseline	8.82	Standard Deviation 1.43	g/dL
The Effect of Oral -L-glutamine on Hematological Parameters	Placebo	Hemoglobin at Baseline	8.71	Standard Deviation 1.17	g/dL
The Effect of Oral -L-glutamine on Hematological Parameters	L-glutamine	Change in Hemoglobin at week 4	0.04	Standard Deviation 0.84	g/dL
The Effect of Oral -L-glutamine on Hematological Parameters	Placebo	Change in Hemoglobin at week 4	0.23	Standard Deviation 0.71	g/dL

1 to 10 of 70Source ClinicalTrials.gov

See all 70 results by group

Participant flow6

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	L-glutamine	152
Overall Study	STARTED	Placebo	78
Overall Study	COMPLETED	L-glutamine	97
Overall Study	COMPLETED	Placebo	59
Overall Study	NOT COMPLETED	L-glutamine	55
Overall Study	NOT COMPLETED	Placebo	19

Source ClinicalTrials.gov

Adverse events264

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk
other	Acute chest syndrome	Blood and lymphatic system disorders	L-glutamine	18	151
other	Acute chest syndrome	Blood and lymphatic system disorders	100% Maltodextrin	21	78
other	Leukocytosis	Blood and lymphatic system disorders	L-glutamine	9	151
other	Leukocytosis	Blood and lymphatic system disorders	100% Maltodextrin	6	78
other	Anaemia	Blood and lymphatic system disorders	L-glutamine	7	151
other	Anaemia	Blood and lymphatic system disorders	100% Maltodextrin	6	78
other	Tachycardia	Cardiac disorders	L-glutamine	8	151
other	Tachycardia	Cardiac disorders	100% Maltodextrin	4	78
other	Sickle cell anaemia with crisis	Congenital, familial and genetic disorders	L-glutamine	123	151
other	Sickle cell anaemia with crisis	Congenital, familial and genetic disorders	100% Maltodextrin	71	78

1 to 10 of 264Source ClinicalTrials.gov

See all 264 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	L-glutamine
Total, all-cause mortality	100% Maltodextrin
Total, other adverse events	L-glutamine	148	151
Total, other adverse events	100% Maltodextrin	78	78
Total, serious adverse events	L-glutamine	118	151
Total, serious adverse events	100% Maltodextrin	68	78

Source ClinicalTrials.gov

Papers2

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as	Source
30021096	DERIVED	PubMed
38775255	DERIVED	PubMed

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons1

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison
L-glutamine vs 100% Maltodextrin: serious adverse events

Source Trial comparisons

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT01179217

GET https://conductscience.org/api/trials/v1/NCT01179217/results?page=2

API reference For AI assistants