Back to resultsA Study of LJPC-501 in Pediatric Patients With Hypotension
Primary Purpose
Catecholamine-resistant Hypotension (CRH), Distributive Shock, High Output Shock
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Angiotensin II
Sponsored by
About this trial
This is an interventional treatment trial for Catecholamine-resistant Hypotension (CRH)
Eligibility Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Sites / Locations
- Investigational Site
- Investigational Site
- Investigational Site
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
LJPC-501
Arm Description
Angiotensin II administered via continuous infusion (1.25 - 40 ng/kg/min) for 24 hours up to 168 hours.
Outcomes
Primary Outcome Measures
Effect of LJPC-501 on mean arterial pressure (MAP)
To evaluate the effect of LJPC-501 infusion on mean arterial pressure (MAP).
Effect of LJPC-501 on sum norepinephrine (NE) equivalent dose
To evaluate the effect of LJPC-501 in the reduction of the sum norepinephrine (NE) equivalent dosing.
Secondary Outcome Measures
Effect of LJPC-501 on the incidence of treatment-emergent adverse events
Effect of LJPC-501 on mean arterial pressure (MAP)
To evaluate the change in MAP over 24 hours after the start of LJPC-501.
Effect of LJPC-501 on serum lactate
To evaluate the change in serum lactate concentrations.
Effect of LJPC-501 on Pediatric Logistic Organ Dysfunction (PELOD)
To evaluate change in Pediatric Logistic Organ Dysfunction (PELOD) score from Screening to 24 hours. The PELOD score is the sum of 6 individual item scores that totals 0-71 points. A higher PELOD score represents a worse outcome.
Effect of LJPC-501 on clinical chemistry laboratory parameters
Safety data for clinical chemistry parameters including ALT, AST, ALP, total bilirubin, direct bilirubin, creatinine, BUN, phosphorus, glucose, albumin, calcium, bicarbonate, chloride, sodium, potassium, magnesium, PT, PTT, and INR. In addition, serum pregnancy test will be assessed at screening to confirm eligibility.
Effect of LJPC-501 on hematology laboratory parameters
Safety data for laboratory hematology parameters including hemoglobin, hematocrit, platelets, and WBC.
Effect of LJPC-501 on blood pressure
Change in blood pressure (mmHg).
Effect of LJPC-501 on heart rate
Change in heart rate (bpm).
Effect of LJPC-501 on body temperature
Change in body temperature (Celsius).
Effect of LJPC-501 on general health
Change in physical examination (by body system).
Effect of LJPC-501 on electrical activity of the heart
Change in the electrical activity of the heart over a period of time using electrodes placed on the skin and recorded by electrocardiogram (ECG).
Effect of LJPC-501 on urine output
Change in urine output (ml).
Full Information
NCT ID
NCT03431077
First Posted
January 18, 2018
Last Updated
August 6, 2018
Sponsor
La Jolla Pharmaceutical Company
1. Study Identification
Unique Protocol Identification Number
NCT03431077
Brief Title
A Study of LJPC-501 in Pediatric Patients With Hypotension
Official Title
An Open-Label, Multi-Center Study of LJPC-501 in Pediatric Patients Who Remain Hypotensive Despite Receiving Fluid Therapy and Vasopressor Therapy
Study Type
Interventional
2. Study Status
Record Verification Date
August 2018
Overall Recruitment Status
Completed
Study Start Date
February 11, 2018 (Actual)
Primary Completion Date
April 14, 2018 (Actual)
Study Completion Date
April 14, 2018 (Actual)
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) 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.
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, Sepsis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
2 (Actual)
8. Arms, Groups, and Interventions
Arm Title
LJPC-501
Arm Type
Experimental
Arm Description
Angiotensin II administered via continuous infusion (1.25 - 40 ng/kg/min) for 24 hours up to 168 hours.
Intervention Type
Drug
Intervention Name(s)
Angiotensin II
Other Intervention Name(s)
Giapreza
Intervention Description
Angiotensin II is a peptide hormone naturally produced by the body that regulates blood pressure via vasoconstriction and sodium reabsorption. LJPC-501 (angiotensin II) is being developed for the treatment of hypotension in patients who do not respond to fluids and vasopressor therapy.
Primary Outcome Measure Information:
Title
Effect of LJPC-501 on mean arterial pressure (MAP)
Description
To evaluate the effect of LJPC-501 infusion on mean arterial pressure (MAP).
Time Frame
2 hours
Title
Effect of LJPC-501 on sum norepinephrine (NE) equivalent dose
Description
To evaluate the effect of LJPC-501 in the reduction of the sum norepinephrine (NE) equivalent dosing.
Time Frame
2 hours
Secondary Outcome Measure Information:
Title
Effect of LJPC-501 on the incidence of treatment-emergent adverse events
Time Frame
Day 7
Title
Effect of LJPC-501 on mean arterial pressure (MAP)
Description
To evaluate the change in MAP over 24 hours after the start of LJPC-501.
Time Frame
24 hours
Title
Effect of LJPC-501 on serum lactate
Description
To evaluate the change in serum lactate concentrations.
Time Frame
2 hours and 24 hours
Title
Effect of LJPC-501 on Pediatric Logistic Organ Dysfunction (PELOD)
Description
To evaluate change in Pediatric Logistic Organ Dysfunction (PELOD) score from Screening to 24 hours. The PELOD score is the sum of 6 individual item scores that totals 0-71 points. A higher PELOD score represents a worse outcome.
Time Frame
24 hours
Title
Effect of LJPC-501 on clinical chemistry laboratory parameters
Description
Safety data for clinical chemistry parameters including ALT, AST, ALP, total bilirubin, direct bilirubin, creatinine, BUN, phosphorus, glucose, albumin, calcium, bicarbonate, chloride, sodium, potassium, magnesium, PT, PTT, and INR. In addition, serum pregnancy test will be assessed at screening to confirm eligibility.
Time Frame
24 hours
Title
Effect of LJPC-501 on hematology laboratory parameters
Description
Safety data for laboratory hematology parameters including hemoglobin, hematocrit, platelets, and WBC.
Time Frame
24 hours
Title
Effect of LJPC-501 on blood pressure
Description
Change in blood pressure (mmHg).
Time Frame
Day 7
Title
Effect of LJPC-501 on heart rate
Description
Change in heart rate (bpm).
Time Frame
Day 7
Title
Effect of LJPC-501 on body temperature
Description
Change in body temperature (Celsius).
Time Frame
Hour 24
Title
Effect of LJPC-501 on general health
Description
Change in physical examination (by body system).
Time Frame
Day 7
Title
Effect of LJPC-501 on electrical activity of the heart
Description
Change in the electrical activity of the heart over a period of time using electrodes placed on the skin and recorded by electrocardiogram (ECG).
Time Frame
Hour 24
Title
Effect of LJPC-501 on urine output
Description
Change in urine output (ml).
Time Frame
Day 7
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:
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.
Exclusion Criteria:
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.
Facility Information:
Facility Name
Investigational Site
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28203
Country
United States
Facility Name
Investigational Site
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45229
Country
United States
Facility Name
Investigational Site
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78207
Country
United States
12. IPD Sharing Statement
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A Study of LJPC-501 in Pediatric Patients With Hypotension
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