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NCT04684381 · ClinicalTrials.gov registry record · Phase 4

Pharmacokinetics and Safety of Endari (L-glutamine) in Sickle Cell Disease Patients

A Phase 4 study, sponsored by Emmaus Medical.

Completed
Registry status
Phase 4
Development phase
13
Enrollment target

NCT04684381: Completed Phase 4 study, sponsored by Emmaus Medical.

NCT04684381 is a Phase 4 study that has completed, run by Emmaus Medical. The registered enrollment target is 13 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (97% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT04684381, a Phase 4 study, has completed, sponsored by Emmaus Medical.

COMPLETED
Registry status
Phase 4
Development phase
13 participants
Enrollment target

Study Summary

L-glutamine has been approved in the US to reduce the acute complications of sickle cell disease (SCD) in adult and pediatric patients 5 years of age and older. The purpose of this single-center, open-label, phase 4 study is to evaluate the pharmacokinetic characteristics and safety of L-glutamine in patients with SCD.

Primary Outcome

PK (AUC)

Interventions

  • DRUG L-glutamine

Trial Details

FieldValue
Enrollment Target 13 participants
Start Date 2021-01-04
Est. Completion 2021-06-30
Phase Phase 4
Emmaus Medical

4 total trials

What the finished NCT04684381 record still lists

NCT04684381 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 13 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (97% lower).

The record links to 0 conditions, and to 1 intervention - of which L-glutamine is the first listed.

NCT04684381 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT04684381 about?

NCT04684381 is a clinical study titled "Pharmacokinetics and Safety of Endari (L-glutamine) in Sickle Cell Disease Patients". L-glutamine has been approved in the US to reduce the acute complications of sickle cell disease (SCD) in adult and pediatric patients 5 years of age and older. The purpose of this single-center, open-label, phase 4 study is to evaluate the pharmacokinetic characteristics and safety of L-glutamine i...

What is the current status of trial NCT04684381?

This trial is currently completed. It is a Phase 4 study. The enrollment target is 13 participants. The study started on 2021-01-04. Estimated completion is 2021-06-30.

What interventions are being tested in trial NCT04684381?

The interventions under investigation include: L-glutamine (DRUG).

Who is sponsoring clinical trial NCT04684381?

This trial is sponsored by Emmaus Medical, which has 4 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT04684381's enrollment target sits among peer trials

13 1910th of 2000 higher than 88 of 2,000 other Phase 4 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 4 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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Source: ClinicalTrials.gov NCT04684381, the US trial registry maintained by the National Library of Medicine. NCT04684381 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.