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

What Was Tested

This registered phase 2 trial tested Angiotensin II.

It had two arms (groups): Active Comparator: LJPC-501 (experimental) and Placebo Comparator: Placebo (placebo comparator).

LJPC-501 Angiotensin II Solution for infusion.

The registry classes the interventions as drug.

Who Took Part

100 planned participants were the target.

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: Paediatric patients \> 2 years (ie, \> 24 months) to \< 18 years of age at enrolment. Patients must have a 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 study drug treatment. Patients are required to have an indwelling arterial line, which is expected to remain present for at least the first 48 hours of study drug treatment. Parent(s) or legal guardian(s) 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 14 exclusion criteria; among the exclusions: patients who are ≤ 2 years (24 months) of age or ≥ 18 years of age at enrolment; 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 randomized, parallel-group and quadruple-blind study.

Random assignment meant chance, not the researchers, decided who got Angiotensin II and who got the comparison, which limits bias.

Groups ran in parallel: each of the participants stayed in one arm throughout.

Blinding on both sides kept the participants and researchers unaware of who received Angiotensin II.

Those kept unaware of assignments: participant, care provider, investigator and outcomes assessor.

It started in 2018-08 with completion listed for 2023-03.

It ran at 2 sites in Belgium (1) and Lithuania (1).

Its stated primary purpose is treatment.

What Was Measured

It also tracked 6 secondary outcomes, for example Effect on Paediatric Logistic Organ Dysfunction-2 (PELOD-2) based on treatment with LJPC-501, Effect on mean arterial pressure (MAP) based on treatment with LJPC-501, Effect on heart rate based on treatment with LJPC-501, Assessment of safety based on number of patients with treatment emergent adverse events based on treatment with LJPC-501 and Assessment of tolerability based on the effect on clinical chemistry parameters based on treatment with LJPC-501.

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of Angiotensin II in 100 people.

Its status is unknown; no results are posted to the registry yet, so nothing here describes outcomes.

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