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

NCT03623529 | Unknown Phase 2 DMC FDA Drug

• 1 other identifier: LJ501-CRH04
• Study Type: interventional
• Target: 100
• Locations: 2 countries
• Sites: 2

Brief 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

Outcome Measures

Primary Outcomes (1)

• Proportion of patients who have a >/= 50% reduction in norepinephrine equivalent doses (NED)

  Hour 3

Secondary Outcomes (6)

• Effect on Paediatric Logistic Organ Dysfunction-2 (PELOD-2) based on treatment with LJPC-501

  Baseline, Hour 24 and Hour 48

• Effect on total catecholamine doses administered based on treatment with LJPC-501

  Baseline, Hour 24 and Hour 48

• Effect on mean arterial pressure (MAP) based on treatment with LJPC-501

  Baseline, Hour 3, Hour 24, and Hour 48

• Effect on heart rate based on treatment with LJPC-501

  Baseline to Hour 3, Hour 24, and Hour 48

• Assessment of safety based on number of patients with treatment emergent adverse events based on treatment with LJPC-501

  Day 7

Study Arms (2)

Active Comparator: LJPC-501

EXPERIMENTAL

LJPC-501 Angiotensin II Solution for infusion

Drug: LJPC-501 (angiotensin II)

Placebo Comparator: Placebo

PLACEBO COMPARATOR

0.9% sodium chloride solution

Drug: Placebo

Interventions

LJPC-501 (angiotensin II) DRUG

Angiotensin II is a peptide hormone naturally produced by the body that regulates blood pressure via vasoconstriction and sodium reabsorption.

Active Comparator: LJPC-501

Placebo DRUG

Placebo Arm

Also known as: 0.9% sodium chloride solution

Placebo Comparator: Placebo

Eligibility Criteria

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

You may qualify if:

• Male and female paediatric patients with catecholamine-resistant hypotension associated with distributive shock.
• Paediatric patients \> 2 years (ie, \> 24 months) to \< 18 years of age at enrolment.
• Patients requiring a sum norepinephrine-equivalent dose \> 0.1 μg/kg/min to maintain age-appropriate target MAP for a minimum of 2 hours and a maximum of 48 hours prior to initiation of study drug.
• 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.
• Patients must have received at least 40 mL/kg of crystalloid or colloid equivalent over the initial 24-hour resuscitation period, and must be adequately volume resuscitated in the opinion of the Investigator, prior to starting study drug.
• Parent(s) or legal guardian(s) 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 (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.
• 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 based on echocardiogram.
• 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 ischaemia or a history of mesenteric ischaemia.
• Patients with active bleeding AND an anticipated need of multiple transfusions (within 48 hours of Screening).
• Patients with active bleeding AND haemoglobin \< 7 g/dL.
• Patients with an expected lifespan of \< 12 hours or expected withdrawal of life support within 24 hours of Screening.
• Patients with a known allergy to mannitol.
• Patients who are currently participating in another clinical trial using an investigational drug not approved in that member country unless specifically approved by the Sponsor.
• Patients of childbearing potential who are known to be pregnant at the time of Screening.

Sponsors & Collaborators

• La Jolla Pharmaceutical Company: lead

Study Sites (2)

Investigational Site

Brussels, Belgium

NOT YET RECRUITING

Investigational Site

Vilnius, 08406, Lithuania

RECRUITING

MeSH Terms

Conditions

Shock, Septic

Interventions

Angiotensin I; Angiotensin II; Sodium Chloride

Condition Hierarchy (Ancestors)

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

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; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Central Study Contacts

Rena Harrigan, MPH

CONTACT

858-207-4264; rharrigan@ljpc.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 29, 2018
• First Posted: August 9, 2018
• Study Start: August 1, 2018
• Primary Completion: March 1, 2023
• Study Completion: April 1, 2023
• Last Updated: August 9, 2018

Record last verified: 2018-08

Locations

LI (1); BE (1)