A Study of LJPC-501 in Pediatric Patients With Hypotension

Completed · Phase 2

Conditions studied: Catecholamine-resistant Hypotension (CRH), Distributive Shock, High Output Shock, Sepsis

In brief

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.

Key facts

Study ID

NCT03431077

Run by

La Jolla Pharmaceutical Company

People needed

2

Starts

2018-02-11

Expected to finish

2018-04-14

Last updated by the study team

2018-08-07

Who can join

Age: 2 and older, up to 17. Sex: any. Healthy volunteers: not accepted.

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.
• Patients of childbearing potential who are known to be pregnant at the time of Screening.

Where it is running

• Investigational Site — Charlotte, North Carolina, United States
• Investigational Site — Cincinnati, Ohio, United States
• Investigational Site — San Antonio, Texas, United States

Full record on ClinicalTrials.gov

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