A Study of LJPC-501 in Pediatric Patients With Hypotension

What Was Tested

In this phase 2 trial, researchers set out to test Angiotensin II.

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.

It had 1 arm (groups): LJPC-501 (experimental).

The registry classes the interventions as drug.

Who Took Part

Enrollment: 2 actual participants took part.

It was open to people of any sex aged from 2 years up to 17 years.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: Pediatric patients 2-17 years of age. 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. Parent or legal guardian is willing and able to provide informed consent and assist the patient in complying with all protocol requirements.

The full record lists 7 inclusion and 16 exclusion criteria; among the exclusions: 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.

How the Study Was Run

It was run as a single-group and open-label study.

Being open-label, the Angiotensin II study did not mask who received what.

Everyone received the same intervention, so there was no separate comparison group inside the trial.

It started in 2018-02-11 with completion listed for 2018-04-14.

It ran at 3 sites in United States (3).

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Effect of LJPC-501 on mean arterial pressure (MAP) (time frame: 2 hours).

It also tracked 12 secondary outcomes, for example Effect of LJPC-501 on the incidence of treatment-emergent adverse events, Effect of LJPC-501 on mean arterial pressure (MAP), Effect of LJPC-501 on serum lactate, Effect of LJPC-501 on Pediatric Logistic Organ Dysfunction (PELOD), Effect of LJPC-501 on clinical chemistry laboratory parameters and Effect of LJPC-501 on hematology laboratory parameters.

What This Means in Plain Language

Put simply, this is a phase 2 trial of Angiotensin II in 2 people.

Its size is small, so on its own it can only give an early look.

The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Angiotensin II compound page, all human trials.