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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 is a Phase 4 study that has completed, run by Emmaus Medical. The registered enrollment target is 13 participants.

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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.

Interventions

  • DRUG L-glutamine

Trial Details

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

Sponsor

Emmaus Medical

4 total trials

What the Registry Record Tells You About NCT04684381

The ClinicalTrials.gov registry entry for NCT04684381 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 13 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Emmaus Medical, which has 4 total studies on file at ClinicalTrials.gov.

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

NCT04684381 reports 0 study locations.

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.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.