search
Back to results

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

Primary Purpose

Catecholamine-resistant Hypotension (CRH), Distributive Shock, High Output Shock

Status
Unknown status
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
LJPC-501 (angiotensin II)
Placebo
Sponsored by
La Jolla Pharmaceutical Company
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Catecholamine-resistant Hypotension (CRH)

Eligibility Criteria

2 Years - 17 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Male and female paediatric patients with catecholamine-resistant hypotension associated with distributive shock.

  1. Paediatric patients > 2 years (ie, > 24 months) to < 18 years of age at enrolment.
  2. 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.
  3. Patients must have a clinical diagnosis of distributive shock in the opinion of the treating team and the Investigator.
  4. Patients are required to have central venous access, which is expected to remain present for the duration of study drug treatment.
  5. 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.
  6. 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.
  7. Parent(s) or legal guardian(s) is willing and able to provide informed consent and assist the patient in complying with all protocol requirements.

Exclusion Criteria:

  1. Patients who are ≤ 2 years (24 months) of age or ≥ 18 years of age at enrolment.
  2. Patients with a standing Do Not Resuscitate order.
  3. Patients diagnosed with acute occlusive coronary syndrome requiring pending intervention.
  4. Patients on veno-arterial (VA) extracorporeal membrane oxygenation (ECMO).
  5. Patients who have been on veno-venous (VV) ECMO for less than 6 hours.
  6. Patients with a clinical suspicion of cardiogenic shock based on echocardiogram.
  7. Patients who have a history of asthma or are currently experiencing bronchospasm requiring the use of inhaled bronchodilators and who are not mechanically ventilated.
  8. Patients with acute mesenteric ischaemia or a history of mesenteric ischaemia.
  9. Patients with active bleeding AND an anticipated need of multiple transfusions (within 48 hours of Screening).
  10. Patients with active bleeding AND haemoglobin < 7 g/dL.
  11. Patients with an expected lifespan of < 12 hours or expected withdrawal of life support within 24 hours of Screening.
  12. Patients with a known allergy to mannitol.
  13. 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.
  14. Patients of childbearing potential who are known to be pregnant at the time of Screening.

Sites / Locations

  • Investigational Site
  • Investigational SiteRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Active Comparator: LJPC-501

Placebo Comparator: Placebo

Arm Description

LJPC-501 Angiotensin II Solution for infusion

0.9% sodium chloride solution

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Effect on Paediatric Logistic Organ Dysfunction-2 (PELOD-2) based on treatment with LJPC-501
Change in PELOD-2 score from baseline to 24 hours and 48 hours after start of LJPC-501. The PELOD-2 score is the sum of 5 individual item scores that totals 0-31 points. A higher PELOD-2 score represents a worse outcome.
Effect on total catecholamine doses administered based on treatment with LJPC-501
Change in total catecholamine doses administered from baseline to 24 hours and 48 hours after start of LJPC-501.
Effect on mean arterial pressure (MAP) based on treatment with LJPC-501
Change in MAP from baseline to 3 hours, 24 hours and 48 hours after start of LJPC-501
Effect on heart rate based on treatment with LJPC-501
Change in heart rate from baseline to 3 hours, 24 hours and 48 hours after start of LJPC-501
Assessment of safety based on number of patients with treatment emergent adverse events based on treatment with LJPC-501
Assessment of tolerability based on the effect on clinical chemistry parameters based on treatment with LJPC-501
Safety data for clinical chemistry parameters including ALT, AST, ALP, total bilirubin, direct bilirubin, creatinine, BUN, lactate, phosphorous, glucose, albumin, calcium, bicarbonate, chloride, sodium, potassium, magnesium

Full Information

First Posted
June 29, 2018
Last Updated
August 6, 2018
Sponsor
La Jolla Pharmaceutical Company
search

1. Study Identification

Unique Protocol Identification Number
NCT03623529
Brief Title
A Study of LJPC-501 in Paediatric Patients With Hypotension Associated With Distributive or Vasodilatory Shock
Official Title
A Randomised, Placebo-controlled, Double-Blind, Multicentre Efficacy and Safety Study of LJPC-501 in Paediatric Patients > 2 to 17 Years of Age With Catecholamine-Resistant Hypotension Associated With Distributive Shock
Study Type
Interventional

2. Study Status

Record Verification Date
August 2018
Overall Recruitment Status
Unknown status
Study Start Date
August 2018 (Anticipated)
Primary Completion Date
March 2023 (Anticipated)
Study Completion Date
April 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
La Jolla Pharmaceutical Company

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Catecholamine-resistant Hypotension (CRH), Distributive Shock, High Output Shock, Septic Shock

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Active Comparator: LJPC-501
Arm Type
Experimental
Arm Description
LJPC-501 Angiotensin II Solution for infusion
Arm Title
Placebo Comparator: Placebo
Arm Type
Placebo Comparator
Arm Description
0.9% sodium chloride solution
Intervention Type
Drug
Intervention Name(s)
LJPC-501 (angiotensin II)
Intervention Description
Angiotensin II is a peptide hormone naturally produced by the body that regulates blood pressure via vasoconstriction and sodium reabsorption.
Intervention Type
Drug
Intervention Name(s)
Placebo
Other Intervention Name(s)
0.9% sodium chloride solution
Intervention Description
Placebo Arm
Primary Outcome Measure Information:
Title
Proportion of patients who have a >/= 50% reduction in norepinephrine equivalent doses (NED)
Time Frame
Hour 3
Secondary Outcome Measure Information:
Title
Effect on Paediatric Logistic Organ Dysfunction-2 (PELOD-2) based on treatment with LJPC-501
Description
Change in PELOD-2 score from baseline to 24 hours and 48 hours after start of LJPC-501. The PELOD-2 score is the sum of 5 individual item scores that totals 0-31 points. A higher PELOD-2 score represents a worse outcome.
Time Frame
Baseline, Hour 24 and Hour 48
Title
Effect on total catecholamine doses administered based on treatment with LJPC-501
Description
Change in total catecholamine doses administered from baseline to 24 hours and 48 hours after start of LJPC-501.
Time Frame
Baseline, Hour 24 and Hour 48
Title
Effect on mean arterial pressure (MAP) based on treatment with LJPC-501
Description
Change in MAP from baseline to 3 hours, 24 hours and 48 hours after start of LJPC-501
Time Frame
Baseline, Hour 3, Hour 24, and Hour 48
Title
Effect on heart rate based on treatment with LJPC-501
Description
Change in heart rate from baseline to 3 hours, 24 hours and 48 hours after start of LJPC-501
Time Frame
Baseline to Hour 3, Hour 24, and Hour 48
Title
Assessment of safety based on number of patients with treatment emergent adverse events based on treatment with LJPC-501
Time Frame
Day 7
Title
Assessment of tolerability based on the effect on clinical chemistry parameters based on treatment with LJPC-501
Description
Safety data for clinical chemistry parameters including ALT, AST, ALP, total bilirubin, direct bilirubin, creatinine, BUN, lactate, phosphorous, glucose, albumin, calcium, bicarbonate, chloride, sodium, potassium, magnesium
Time Frame
Hour 24 and Hour 48

10. Eligibility

Sex
All
Minimum Age & Unit of Time
2 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Rena Harrigan, MPH
Phone
858-207-4264
Ext
1129
Email
rharrigan@ljpc.com
Facility Information:
Facility Name
Investigational Site
City
Brussels
Country
Belgium
Individual Site Status
Not yet recruiting
Facility Name
Investigational Site
City
Vilnius
ZIP/Postal Code
08406
Country
Lithuania
Individual Site Status
Recruiting

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs