Arginine Therapy for Sickle Cell Disease
(STArT Trial)
Recruiting at 9 trial locations
Age: < 65
Sex: Any
Trial Phase: Phase 3
Sponsor: Emory University
Pivotal Trial (Near Approval)This treatment is in the last trial phase before FDA approval
Prior Safety DataThis treatment has passed at least one previous human trial
Approved in 2 JurisdictionsThis treatment is already approved in other countries
Trial Summary
What is the purpose of this trial?
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.
Research Team
Claudia Morris, MD
Principal Investigator
Emory University
Eligibility Criteria
The STArT trial is for children and young adults aged 3-21 with sickle cell disease experiencing pain episodes needing medical care. They must not have had certain treatments or hospitalizations recently, be stable without severe anemia, and able to understand English or Spanish.Inclusion Criteria
I have been diagnosed with sickle cell disease.
I have had severe pain from sickle cell disease treated with strong painkillers.
I am between 3 and 21 years old.
Exclusion Criteria
Previous randomization in this arginine phase 3 RCT; OR
I am 18 or older but cannot make medical decisions for myself.
pregnancy; OR
See 15 more
Treatment Details
Interventions
- Arginine Hydrochloride
Trial OverviewThis study tests IV arginine therapy versus saline (a placebo) in managing pain during vaso-occlusive episodes in sickle cell patients. It aims to determine the effectiveness and safety of arginine compared to a standard treatment.
Participant Groups
2Treatment groups
Experimental Treatment
Placebo Group
Group I: L-Arginine HydrochlorideExperimental Treatment1 Intervention
Participants receiving L-arginine hydrochloride in parenteral form. Participants receive up to 21 doses, with participants who are discharged early receiving fewer doses.
Group II: PlaceboPlacebo Group1 Intervention
Participants receiving normal saline as a placebo for L-arginine hydrochloride for up to 21 doses, with participants who are discharged early receiving fewer doses.
Arginine Hydrochloride is already approved in European Union, United States for the following indications:
Approved in European Union as L-arginine for:
- Nutritional supplement
- COVID-19-related conditions
Approved in United States as L-arginine for:
- Nutritional supplement
- COVID-19-related conditions
Find a Clinic Near You
Who Is Running the Clinical Trial?
Emory University
Lead Sponsor
Trials
1,735
Recruited
2,605,000+
Claudia R. Morris
Lead Sponsor
Trials
1
Recruited
360+
National Heart, Lung, and Blood Institute (NHLBI)
Collaborator
Trials
3,987
Recruited
47,860,000+
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