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Amino Acid

L-glutamine for Sickle Cell Disease

Phase 4
Waitlist Available
Research Sponsored by Emmaus Medical, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Timeline
Screening 3 weeks
Treatment Varies
Follow Up week 1 day 1 (0.1 g/kg dose) and week 2 day 1 (0.3 g/kg dose. week 3 day 1 and week4 day1 (0.6 g/kg once daily dose)
Awards & highlights

Study Summary

This study is evaluating whether L-glutamine may help reduce complications of sickle cell disease.

Eligible Conditions
  • Sickle Cell Disease
  • Pharmacokinetics

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~week 1 day 1 (0.1 g/kg dose) and week 2 day 1 (0.3 g/kg dose. week 3 day 1 and week4 day1 (0.6 g/kg once daily dose)
This trial's timeline: 3 weeks for screening, Varies for treatment, and week 1 day 1 (0.1 g/kg dose) and week 2 day 1 (0.3 g/kg dose. week 3 day 1 and week4 day1 (0.6 g/kg once daily dose) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Area Under Curve (AUC) of L-glutamine at 0.1 g/kg twice daily, 0.3 g/kg twice daily, and 0.6 g/kg once daily in SCD patients
Half-life (t1/2) of L-glutamine at 0.1 g/kg twice daily, 0.3 g/kg twice daily, and 0.6 g/kg once daily in SCD patients
Maximum Plasma Concentration (Cmax) of L-glutamine at 0.1 g/kg twice daily, 0.3 g/kg twice daily, and 0.6 g/kg once daily in SCD patients
+1 more
Secondary outcome measures
Ammonia levels
Effect of Food on L-glutamine Area Under Curve (AUC)
Effect of Food on L-glutamine Maximum Plasma Concentration (Cmax)
+5 more

Side effects data

From 2014 Phase 3 trial • 230 Patients • NCT01179217
81%
Sickle cell anaemia with crisis
25%
Constipation
23%
Nausea
22%
Pyrexia
21%
Headache
18%
Upper respiratory tract infection
17%
Cough
16%
Pain in extremity
15%
Vomiting
14%
Chest pain
13%
Back pain
13%
Arthralgia
12%
Abdominal pain
12%
Acute chest syndrome
11%
Abdominal pain upper
10%
Ocular icterus
9%
Pruritus
8%
Diarrhoea
8%
Acute Chest Syndrome
7%
Urinary tract infection
7%
Nasopharyngitis
7%
Nasal congestion
7%
Oropharnyngeal pain
6%
Fatigue
6%
Pneumonia
6%
Leukocytosis
5%
Anaemia
5%
Oedema peripheral
5%
Dizziness
5%
Tachycardia
5%
Dyspnoea
4%
Hypomanesaemia
4%
Hypokalaemia
3%
Epistaxis
3%
Gastroenteritis
3%
Hyperkalaemia
3%
Asthma
3%
Bronchitis
3%
Hypoxia
2%
Rash
2%
Influenza
1%
Pulmonary embolism
1%
Bronchial hyperreactivity
1%
Cardiac Arrest
1%
Pharnygitis streptococcal
1%
Leucocytosis
1%
Osteomyelitis
1%
Skin ulcer
1%
Sinustitis
1%
Strabismus correction
1%
Dehydration
1%
Gastrointestinal viral infection
1%
Gastritis
1%
Cholelithiasis
1%
Lobar pneumonia
1%
Sepsis
1%
Death
1%
Rhinitis allergic
1%
Joint effusion
1%
Haematuria
1%
Transient ischaemic attack
1%
Post-traumatic reaction
1%
Renal failure acute
1%
Aplastic anaemia
1%
Haemolysis
1%
Hypersplenism
1%
Pain
1%
Cholecystitis
1%
Cholecystitis acute
1%
Complication of device removal
1%
Device malfunction
1%
Fall
1%
Haemolytic transfusion reaction
1%
Pregnancy
1%
Deep vein thrombosis
1%
Thrombophlebits superficial
100%
80%
60%
40%
20%
0%
Study treatment Arm
L-glutamine
100% Maltodextrin

Trial Design

1Treatment groups
Experimental Treatment
Group I: L-glutamineExperimental Treatment1 Intervention
Pharmacokinetic characteristics of L-glutamine
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
L-Glutamine
FDA approved

Find a Location

Who is running the clinical trial?

Emmaus Medical, Inc.Lead Sponsor
7 Previous Clinical Trials
369 Total Patients Enrolled
Yutaka Niihara, MDStudy ChairEmmaus Medical, Inc.
2 Previous Clinical Trials
85 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
Pharmacokinetics and Safety of Endari (L-glutamine) in Sickle Cell Disease Patients
2021. "Pharmacokinetics and Safety of Endari (L-glutamine) in Sickle Cell Disease Patients". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04684381.
~3 spots leftby Apr 2025
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