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Trial record 70 of 303 for:    Recruiting, Not yet recruiting, Available Studies | Pediatrics

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

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ClinicalTrials.gov Identifier: NCT03623529
Recruitment Status : Recruiting
First Posted : August 9, 2018
Last Update Posted : August 9, 2018
Sponsor:
Information provided by (Responsible Party):
La Jolla Pharmaceutical Company

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.

Condition or disease Intervention/treatment Phase
Catecholamine-resistant Hypotension (CRH) Distributive Shock High Output Shock Septic Shock Drug: LJPC-501 (angiotensin II) Drug: Placebo Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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
Estimated Study Start Date : August 2018
Estimated Primary Completion Date : March 2023
Estimated Study Completion Date : April 2023

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Active Comparator: LJPC-501
LJPC-501 Angiotensin II Solution for infusion
Drug: LJPC-501 (angiotensin II)
Angiotensin II is a peptide hormone naturally produced by the body that regulates blood pressure via vasoconstriction and sodium reabsorption.

Placebo Comparator: Placebo Comparator: Placebo
0.9% sodium chloride solution
Drug: Placebo
Placebo Arm
Other Name: 0.9% sodium chloride solution




Primary Outcome Measures :
  1. Proportion of patients who have a >/= 50% reduction in norepinephrine equivalent doses (NED) [ Time Frame: Hour 3 ]

Secondary Outcome Measures :
  1. Effect on Paediatric Logistic Organ Dysfunction-2 (PELOD-2) based on treatment with LJPC-501 [ Time Frame: Baseline, Hour 24 and Hour 48 ]
    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.

  2. Effect on total catecholamine doses administered based on treatment with LJPC-501 [ Time Frame: Baseline, Hour 24 and Hour 48 ]
    Change in total catecholamine doses administered from baseline to 24 hours and 48 hours after start of LJPC-501.

  3. Effect on mean arterial pressure (MAP) based on treatment with LJPC-501 [ Time Frame: Baseline, Hour 3, Hour 24, and Hour 48 ]
    Change in MAP from baseline to 3 hours, 24 hours and 48 hours after start of LJPC-501

  4. Effect on heart rate based on treatment with LJPC-501 [ Time Frame: Baseline to Hour 3, Hour 24, and Hour 48 ]
    Change in heart rate from baseline to 3 hours, 24 hours and 48 hours after start of LJPC-501

  5. Assessment of safety based on number of patients with treatment emergent adverse events based on treatment with LJPC-501 [ Time Frame: Day 7 ]
  6. Assessment of tolerability based on the effect on clinical chemistry parameters based on treatment with LJPC-501 [ Time Frame: Hour 24 and Hour 48 ]
    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



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Ages Eligible for Study:   2 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03623529


Contacts
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Contact: Rena Harrigan, MPH 858-207-4264 ext 1129 rharrigan@ljpc.com

Locations
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Belgium
Investigational Site Not yet recruiting
Brussels, Belgium
Lithuania
Investigational Site Recruiting
Vilnius, Lithuania, 08406
Sponsors and Collaborators
La Jolla Pharmaceutical Company

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Responsible Party: La Jolla Pharmaceutical Company
ClinicalTrials.gov Identifier: NCT03623529     History of Changes
Other Study ID Numbers: LJ501-CRH04
First Posted: August 9, 2018    Key Record Dates
Last Update Posted: August 9, 2018
Last Verified: August 2018

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Shock
Shock, Septic
Hypotension
Pathologic Processes
Sepsis
Infection
Systemic Inflammatory Response Syndrome
Inflammation
Vascular Diseases
Cardiovascular Diseases
Pharmaceutical Solutions
Angiotensin II
Giapreza
Angiotensinogen
Vasoconstrictor Agents
Serine Proteinase Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action