Catecholamine-resistant Hypotension (CRH)Phase 2NCT03431077
A Study of LJPC-501 in Pediatric Patients With Hypotension
A Phase 2 study testing Angiotensin II in people with Catecholamine-resistant Hypotension (CRH) and Distributive Shock, run by La Jolla Pharmaceutical Company at 3 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 2 to 17 years
- Conditions the study is for
- Catecholamine-resistant Hypotension (CRH), Distributive Shock, High Output Shock
- What is being tested?
- Angiotensin II
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2 participants
- Where
- 3 sitesUnited States
- Study dates
- 11 Feb 2018to 14 Apr 2018
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Investigational Site
Charlotte, North Carolina, 28203
Investigational Site
Cincinnati, Ohio, 45229
Investigational Site
San Antonio, Texas, 78207
About this study
Official title: An Open-Label, Multi-Center Study of LJPC-501 in Pediatric Patients Who Remain Hypotensive Despite Receiving Fluid Therapy and Vasopressor Therapy
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.
- Being tested
- Angiotensin II
- Medical subject headings
- Sepsis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Angiotensin IIDrug
Also called Giapreza
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.
| Study group | Role | What they receive |
|---|---|---|
| LJPC-501 | Experimental | Angiotensin II administered via continuous infusion (1.25 - 40 ng/kg/min) for 24 hours up to 168 hours. Receives: Drug: Angiotensin II |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effect of LJPC-501 on mean arterial pressure (MAP)
To evaluate the effect of LJPC-501 infusion on mean arterial pressure (MAP).
Measured: 2 hours
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.
Measured: 2 hours
Secondary outcomes (12)
Effect of LJPC-501 on the incidence of treatment-emergent adverse events
Measured: Day 7
Effect of LJPC-501 on mean arterial pressure (MAP)
To evaluate the change in MAP over 24 hours after the start of LJPC-501.
Measured: 24 hours
Effect of LJPC-501 on serum lactate
To evaluate the change in serum lactate concentrations.
Measured: 2 hours and 24 hours
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.
Measured: 24 hours
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.
Measured: 24 hours
Effect of LJPC-501 on hematology laboratory parameters
Safety data for laboratory hematology parameters including hemoglobin, hematocrit, platelets, and WBC.
Measured: 24 hours
Effect of LJPC-501 on blood pressure
Change in blood pressure (mmHg).
Measured: Day 7
Effect of LJPC-501 on heart rate
Change in heart rate (bpm).
Measured: Day 7
Effect of LJPC-501 on body temperature
Change in body temperature (Celsius).
Measured: Hour 24
Effect of LJPC-501 on general health
Change in physical examination (by body system).
Measured: Day 7
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).
Measured: Hour 24
Effect of LJPC-501 on urine output
Change in urine output (ml).
Measured: Day 7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2018
- Study start11 Feb 2018
- Primary completion14 Apr 2018
- Study completion14 Apr 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Catecholamine-resistant Hypotension (CRH)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- La Jolla Pharmaceutical Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03431077
- Sponsor's protocol ID
- LJ501-CRH02
- Status last verified
- Aug 2018
- First submitted
- 18 Jan 2018
- Last updated
- 7 Aug 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label, Multi-Center Study of LJPC-501 in Pediatric Patients Who Remain Hypotensive Despite Receiving Fluid Therapy and Vasopressor Therapy
- ClinicalTrials.gov ID
- NCT03431077
- Acronym / sponsor ID
- LJ501-CRH02
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2 participants (actual)
- Lead sponsor
- La Jolla Pharmaceutical CompanyIndustry (pharma, biotech, devices)
- Study start
- 11 Feb 2018 (actual)
- Primary completion
- 14 Apr 2018 (actual)
- Study completion
- 14 Apr 2018 (actual)
- First posted
- 13 Feb 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| LJPC-501 | Experimental | Drug: Angiotensin IIAngiotensin II administered via continuous infusion (1.25 - 40 ng/kg/min) for 24 hours up to 168 hours. |
Who may qualify
- Ages
- 2 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (16 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Angiotensin IIAlso: GiaprezaAngiotensin 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. | Drug | LJPC-501 |
Primary outcome
Effect of LJPC-501 on mean arterial pressure (MAP)
Time frame: 2 hours
To evaluate the effect of LJPC-501 infusion on mean arterial pressure (MAP).
Effect of LJPC-501 on sum norepinephrine (NE) equivalent dose
Time frame: 2 hours
To evaluate the effect of LJPC-501 in the reduction of the sum norepinephrine (NE) equivalent dosing.
12 secondary outcomes
Effect of LJPC-501 on the incidence of treatment-emergent adverse events
Time frame: Day 7
Effect of LJPC-501 on mean arterial pressure (MAP)
Time frame: 24 hours
Effect of LJPC-501 on serum lactate
Time frame: 2 hours and 24 hours
Effect of LJPC-501 on Pediatric Logistic Organ Dysfunction (PELOD)
Time frame: 24 hours
Effect of LJPC-501 on clinical chemistry laboratory parameters
Time frame: 24 hours
Effect of LJPC-501 on hematology laboratory parameters
Time frame: 24 hours
Effect of LJPC-501 on blood pressure
Time frame: Day 7
Effect of LJPC-501 on heart rate
Time frame: Day 7
Effect of LJPC-501 on body temperature
Time frame: Hour 24
Effect of LJPC-501 on general health
Time frame: Day 7
Effect of LJPC-501 on electrical activity of the heart
Time frame: Hour 24
Effect of LJPC-501 on urine output
Time frame: Day 7
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2018.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Angiotensin II in people with Catecholamine-resistant Hypotension (CRH) and Distributive Shock, run by La Jolla Pharmaceutical Company at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Effect of LJPC-501 on mean arterial pressure (MAP) (time frame: 2 hours). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Aug 2018.