NCT03431077

A Study of LJPC-501 in Pediatric Patients With Hypotension

An Open-Label, Multi-Center Study of LJPC-501 in Pediatric Patients Who Remain Hypotensive Despite Receiving Fluid Therapy and Vasopressor Therapy

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 2 (actual)
• Sponsor: La Jolla Pharmaceutical Company · Industry
• Sex: All
• Age: 2 Years – 17 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Catecholamine-resistant Hypotension (CRH)
• Distributive Shock
• High Output Shock
• Sepsis

Interventions

Type	Name	Description
DRUG	Angiotensin II	Angiotensin II is a peptide hormone naturally produced by the body that regulates blood pressure via vasoconstriction and sodium reabsorption. LJPC-501 (angiotensin II) is being developed for the treatment of hypotension in patients who do not respond to fluids and vasopressor therapy.

Timeline

• Start date: 2018-02-11
• Primary completion: 2018-04-14
• Completion: 2018-04-14
• First posted: 2018-02-13
• Last updated: 2018-08-07

Locations

3 sites across 1 country: United States

Regulatory

• FDA-regulated drug study