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Sickle Cell Disease Treatment With Arginine Therapy (STArT) Trial — STArT  

Sickle Cell Disease Clinical Trial

Official title:
Sickle Cell Disease Treatment With Arginine Therapy (STArT) Trial

Clinical Trial Summary

The trial of IV arginine therapy in children with Vaso-occlusive painful episodes (VOE) in sickle cell disease (SCD) is designed to further knowledge on efficacy and safety of the therapy.

Clinical Trial Description

The trial is designed as a double-blind, placebo controlled, randomized, phase 3, multi-center trial of IV arginine therapy in children with Vaso-occlusive painful episodes (VOE) in sickle cell disease (SCD) to further knowledge on efficacy and safety of the therapy. The exploratory objective is to more fully characterize the arginine metabolome in children with SCD during VOE, and evaluate the effects of arginine therapy on global arginine bioavailability and mitochondrial function together with important clinical outcomes (time to VOE resolution, pain scores, total parenteral opioid use, Patient-Reported Outcomes (PROs), and hospital length of stay in children with SCD and VOE. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04839354
Study type Interventional
Source Emory University
Contact Claudia Morris, MD
Phone 404-785-7141
Email claudia.r.morris@emory.edu
Status Recruiting
Phase Phase 3
Start date June 21, 2021
Completion date April 2027
View Details
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