A Study of LJPC-501 in Pediatric Patients With Hypotension

NCT03431077 | Completed Phase 2 DMC FDA Drug

• 1 other identifier: LJ501-CRH02
• Study Type: interventional
• Target: 2
• Locations: 1 country
• Sites: 3

Brief 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

Outcome Measures

Primary Outcomes (2)

• Effect of LJPC-501 on mean arterial pressure (MAP)

  To evaluate the effect of LJPC-501 infusion on mean arterial pressure (MAP).

  2 hours

• Effect of LJPC-501 on sum norepinephrine (NE) equivalent dose

  To evaluate the effect of LJPC-501 in the reduction of the sum norepinephrine (NE) equivalent dosing.

  2 hours

Secondary Outcomes (12)

• Effect of LJPC-501 on the incidence of treatment-emergent adverse events

  Day 7

• Effect of LJPC-501 on mean arterial pressure (MAP)

  24 hours

• Effect of LJPC-501 on serum lactate

  2 hours and 24 hours

• Effect of LJPC-501 on Pediatric Logistic Organ Dysfunction (PELOD)

  24 hours

• Effect of LJPC-501 on clinical chemistry laboratory parameters

  24 hours

Study Arms (1)

LJPC-501

EXPERIMENTAL

Angiotensin II administered via continuous infusion (1.25 - 40 ng/kg/min) for 24 hours up to 168 hours.

Drug: Angiotensin II

Interventions

Angiotensin II DRUG

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.

Also known as: Giapreza

LJPC-501

Eligibility Criteria

• Age: 2 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Pediatric patients 2-17 years of age.
• Patients requiring a total sum NE equivalent dose of \> 0.1 μg/kg/min for a minimum of 2 hours and a maximum of 48 hours prior to initiation of LJPC-501 dosing.
• Patients must have clinical diagnosis of distributive shock in the opinion of the treating team and the Investigator.
• Patients are required to have central venous access, which is expected to remain present for the duration of LJPC-501 treatment.
• Patients are required to have an indwelling arterial line, which is expected to remain present for at least the first 24 hours of LJPC-501 treatment.
• Patients must have received at least 40 mL/kg of crystalloid or colloid equivalent over the initial 24-hour resuscitation period, and are adequately volume resuscitated in the opinion of the Investigator.
• Parent or legal guardian is willing and able to provide informed consent and assist the patient in complying with all protocol requirements.

You may not qualify if:

• Patients who are \< 2 years of age or ≥ 18 years of age.
• Patients with a standing Do Not Resuscitate order.
• Patients diagnosed with acute occlusive coronary syndrome requiring pending intervention.
• Patients on veno-arterial (VA) extracorporeal membrane oxygenation (ECMO).
• Patients who have been on veno-venous (VV) ECMO for less than 6 hours.
• Patients with a clinical suspicion of cardiogenic shock.
• Patients who have a history of asthma or are currently experiencing bronchospasm requiring the use of inhaled bronchodilators and who are not mechanically ventilated.
• Patients with acute mesenteric ischemia or a history of mesenteric ischemia.
• Patients with active bleeding AND an anticipated need of multiple transfusions (within 48 hours of Screening).
• Patients with active bleeding AND hemoglobin \< 7 g/dL or any other condition that would contraindicate serial blood sampling.
• Patients with an absolute neutrophil count (ANC) of \< 500 cells/mm3.
• Patients requiring more than 5 mg/kg daily of hydrocortisone or equivalent glucocorticoid medication as a standing dose.
• Patients with an expected lifespan of \< 12 hours or withdrawal of life support within 24 hours of Screening.
• Patients with a known allergy to mannitol.
• Patients who are currently participating in another investigational clinical trial.

Sponsors & Collaborators

• La Jolla Pharmaceutical Company: lead

Study Sites (3)

Investigational Site

Charlotte, North Carolina, 28203, United States

Location

Investigational Site

Cincinnati, Ohio, 45229, United States

Location

Investigational Site

San Antonio, Texas, 78207, United States

Location

MeSH Terms

Conditions

Sepsis

Interventions

Angiotensin II; Giapreza

Condition Hierarchy (Ancestors)

Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Angiotensins; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Neuropeptides; Peptides; Amino Acids, Peptides, and Proteins; Oligopeptides; Nerve Tissue Proteins; Proteins; Autacoids; Inflammation Mediators; Biological Factors

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 18, 2018
• First Posted: February 13, 2018
• Study Start: February 11, 2018
• Primary Completion: April 14, 2018
• Study Completion: April 14, 2018
• Last Updated: August 7, 2018

Record last verified: 2018-08

Locations

US (3)