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A Study of LJPC-501 in Pediatric Patients With Hypotension
The objective of this study is to evaluate the effect of LJPC-501 infusion on mean arterial pressure (MAP) or reduction in sum norepinephrine (NE) equivalent dosing, at Hour 2 after the start of LJPC-501, in pediatric patients who remain hypotensive despite receiving fluid therapy and vasopressor therapy. In addition, this study will evaluate the safety and tolerability of LJPC-501 in pediatric patients, the change in MAP over 24 hours after the start of LJPC-501, the change in serum lactate concentrations, and the change in Pediatric Logistic Organ Dysfunction (PELOD) scores.
Details
| Lead sponsor | La Jolla Pharmaceutical Company |
|---|---|
| Phase | PHASE2 |
| Status | COMPLETED |
| Enrolment | 2 |
| Start date | Sun Feb 11 2018 00:00:00 GMT+0000 (Coordinated Universal Time) |
| Completion | Sat Apr 14 2018 00:00:00 GMT+0000 (Coordinated Universal Time) |
Conditions
- Catecholamine-resistant Hypotension (CRH)
- Distributive Shock
- High Output Shock
- Sepsis
Interventions
- Angiotensin II
Countries
United States