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COMPLETED
NCT04839354
PHASE3

Sickle Cell Disease Treatment With Arginine Therapy (STArT) Trial

Sponsor: Claudia R. Morris

View on ClinicalTrials.gov

Summary

The trial is designed to test intravenous (IV) arginine therapy in children with sickle cell disease (SCD) and vaso-occlusive painful episodes (VOE) to further knowledge on efficacy and safety of this orphan drug.

Key Details

Gender

All

Age Range

3 Years - 21 Years

Study Type

INTERVENTIONAL

Enrollment

271

Start Date

2021-06-21

Completion Date

2024-07-11

Last Updated

2026-06-23

Healthy Volunteers

No

Interventions

DRUG

L-Arginine Hydrochloride

A one-time L-arginine hydrochloride loading dose of 200 mg/kg will be administered intravenously (IV) followed by a standard dose of 100 mg/kg given by IV three times per day (TID).

OTHER

Normal saline

A placebo of normal saline will be administered by IV with a loading dose of 2ml/kg followed by 1ml/kg given by IV three times per day (TID).

Locations (10)

Children's Hospital Los Angeles

Los Angeles, California, United States

UCSF Benioff Children's Hospital

San Francisco, California, United States

Children's National Medical Center

Washington D.C., District of Columbia, United States

Children's Healthcare of Atlanta at Hughes Spalding

Atlanta, Georgia, United States

Children's Healthcare of Atlanta at Egleston

Atlanta, Georgia, United States

Washington University/St. Louis Children's Hospital

St Louis, Missouri, United States

Nationwide Children's Hospital

Columbus, Ohio, United States

Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, United States

Texas Children's Hospital/Baylor College of Medicine

Houston, Texas, United States

Medical College of Wisconsin/Wisconsin Children's Hospital

Wauwatosa, Wisconsin, United States