NCT03623529

A Study of LJPC-501 in Paediatric Patients With Hypotension Associated With Distributive or Vasodilatory Shock

A Randomised, Placebo-controlled, Double-Blind, Multicentre Efficacy and Safety Study of LJPC-501 in Paediatric Patients > 2 to 17 Years of Age With Catecholamine-Resistant Hypotension Associated With Distributive Shock

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 100 (estimated)
• 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) as assessed by standard of care vasopressor dose reduction in pediatric patients with catecholamine-resistant hypotension (CRH). In addition, this study will evaluate the safety and tolerability of LJPC-501 in pediatric patients, evaluate changes in catecholamine and other vasopressor doses over time, evaluate the change in MAP over time, and the change in Pediatric Logistic Organ Dysfunction-2 (PELOD-2) scores.

Conditions

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

Interventions

Type	Name	Description
DRUG	LJPC-501 (angiotensin II)	Angiotensin II is a peptide hormone naturally produced by the body that regulates blood pressure via vasoconstriction and sodium reabsorption.
DRUG	Placebo	Placebo Arm

Timeline

• Start date: 2018-08-01
• Primary completion: 2023-03-01
• Completion: 2023-04-01
• First posted: 2018-08-09
• Last updated: 2018-08-09

Locations

2 sites across 2 countries: Belgium, Lithuania

Regulatory

• FDA-regulated drug study