Sickle Cell Disease Treatment With Arginine Therapy (STArT) Trial (STArT)
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- STATUS
- Recruiting
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- End date
- Apr 24, 2027
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- participants needed
- 360
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- sponsor
- Emory University
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.
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.
Details
| Condition | Sickle Cell Disease |
|---|---|
| Treatment | Normal saline, Arginine hydrochloride |
| Clinical Study Identifier | NCT04839354 |
| Sponsor | Emory University |
| Last Modified on | 24 March 2022 |
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