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

NCT04684381 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 13

Last updated 2022-08-02

No results posted yet for this 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.

Conditions

Interventions

DRUG

L-glutamine

Pharmacokinetic study

Sponsors & Collaborators

  • Emmaus Medical, Inc.

    lead INDUSTRY

Principal Investigators

  • Yutaka Niihara, MD · Emmaus Medical, Inc.

Study Design

Allocation
NA
Purpose
BASIC_SCIENCE
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
5 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-01-04
Primary Completion
2021-06-30
Completion
2021-06-30
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04684381 on ClinicalTrials.gov