Actively recruiting clinical trials of NO and related agents, antiplatelet agents, and anticoagulants in SCD
| Mechanism . | Drug . | Sponsor . | NCT number (study acronym) . | Clinical phase/status . | Study design/intervention . | Number/age . | Outcome . |
|---|---|---|---|---|---|---|---|
| Increased NO production | Arginine | Emory University | NCT02447874 | Phase 1/2 | IV infusion 3 times a day for maximum of 7 d | 21/7-21 y | Pharmacokinetics, NO metabolites |
| NCT04839354 (STArT trial) | Phase 3 | One-time L-arginine loading dose (200 mg/kg IV) + standard dose (100 mg/kg IV 3 times a day) | 360/3-21 y | Evaluate change in time to crisis resolution, pain scores, total parenteral opioid use, PROMIS pain interference, pain-behavior and fatigue score | |||
| L-citrulline | Asklepion Pharmaceuticals | NCT04852172 | Phase 1/2 | IV infusion (bolus + continuous infusion for 7 h) during VOC Part 1: identify optimum dose regime Part 2: doses selected from part 1 vs placebo | 120/6-21 y | Pharmacokinetics, adverse events, effect on VOC including amount of overall opioid use, time to resolution of VOC |
| Mechanism . | Drug . | Sponsor . | NCT number (study acronym) . | Clinical phase/status . | Study design/intervention . | Number/age . | Outcome . |
|---|---|---|---|---|---|---|---|
| Increased NO production | Arginine | Emory University | NCT02447874 | Phase 1/2 | IV infusion 3 times a day for maximum of 7 d | 21/7-21 y | Pharmacokinetics, NO metabolites |
| NCT04839354 (STArT trial) | Phase 3 | One-time L-arginine loading dose (200 mg/kg IV) + standard dose (100 mg/kg IV 3 times a day) | 360/3-21 y | Evaluate change in time to crisis resolution, pain scores, total parenteral opioid use, PROMIS pain interference, pain-behavior and fatigue score | |||
| L-citrulline | Asklepion Pharmaceuticals | NCT04852172 | Phase 1/2 | IV infusion (bolus + continuous infusion for 7 h) during VOC Part 1: identify optimum dose regime Part 2: doses selected from part 1 vs placebo | 120/6-21 y | Pharmacokinetics, adverse events, effect on VOC including amount of overall opioid use, time to resolution of VOC |