Catecholamine-resistant Hypotension (CRH)Phase 2NCT03623529
A Study of LJPC-501 in Paediatric Patients With Hypotension Associated With Distributive or Vasodilatory Shock
A Phase 2 study testing LJPC-501 (angiotensin II) in people with Catecholamine-resistant Hypotension (CRH) and Distributive Shock, run by La Jolla Pharmaceutical Company at 2 sites in 2 countries.
Trial 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). 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?
- LJPC-501 (angiotensin II)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 2 sitesin 2 countries
- Study dates
- Aug 2018to Apr 2023
- 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
- 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.
Who cannot join
- 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.
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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 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.
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
About this study
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
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
- Being tested
- LJPC-501 (angiotensin II), Placebo
- Medical subject headings
- Shock, Septic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
PlaceboDrug
Also called 0.9% sodium chloride solution
Placebo Arm
| Study group | Role | What they receive |
|---|---|---|
| Active Comparator: LJPC-501 | Experimental | LJPC-501 Angiotensin II Solution for infusion Receives: Drug: LJPC-501 (angiotensin II) |
| Placebo Comparator: Placebo | Placebo comparator | 0.9% sodium chloride solution Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of patients who have a >/= 50% reduction in norepinephrine equivalent doses (NED)
Measured: Hour 3
Secondary outcomes (6)
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.
Measured: Baseline, Hour 24 and Hour 48
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.
Measured: Baseline, Hour 24 and Hour 48
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
Measured: Baseline, Hour 3, Hour 24, and Hour 48
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
Measured: 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
Measured: Day 7
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
Measured: Hour 24 and Hour 48
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2018
- Study startAug 2018 (estimated)
- Primary completionMar 2023 (estimated)
- Study completionApr 2023 (estimated)
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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 100 participants (estimated)
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
- NCT03623529
- Sponsor's protocol ID
- LJ501-CRH04
- Status last verified
- Aug 2018
- First submitted
- 29 Jun 2018
- Last updated
- 9 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 9 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03623529
- Acronym / sponsor ID
- LJ501-CRH04
- Conditions
- Catecholamine-resistant Hypotension (CRH), Distributive Shock, High Output Shock, Septic Shock
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- La Jolla Pharmaceutical CompanyIndustry (pharma, biotech, devices)
- Study start
- Aug 2018 (estimated)
- Primary completion
- Mar 2023 (estimated)
- Study completion
- Apr 2023 (estimated)
- First posted
- 9 Aug 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) 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active Comparator: LJPC-501 | Experimental | Drug: LJPC-501 (angiotensin II)LJPC-501 Angiotensin II Solution for infusion |
| Placebo Comparator: Placebo | Placebo comparator | Drug: Placebo0.9% sodium chloride solution |
Who may qualify
- Ages
- 2 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (14 listed)
- 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.
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 |
|---|---|---|
| LJPC-501 (angiotensin II)Angiotensin II is a peptide hormone naturally produced by the body that regulates blood pressure via vasoconstriction and sodium reabsorption. | Drug | Active Comparator: LJPC-501 |
| PlaceboAlso: 0.9% sodium chloride solutionPlacebo Arm | Drug | Placebo Comparator: Placebo |
Primary outcome
Proportion of patients who have a >/= 50% reduction in norepinephrine equivalent doses (NED)
Time frame: Hour 3
6 secondary outcomes
Effect on Paediatric Logistic Organ Dysfunction-2 (PELOD-2) based on treatment with LJPC-501
Time frame: Baseline, Hour 24 and Hour 48
Effect on total catecholamine doses administered based on treatment with LJPC-501
Time frame: Baseline, Hour 24 and Hour 48
Effect on mean arterial pressure (MAP) based on treatment with LJPC-501
Time frame: Baseline, Hour 3, Hour 24, and Hour 48
Effect on heart rate based on treatment with LJPC-501
Time frame: 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
Time frame: Day 7
Assessment of tolerability based on the effect on clinical chemistry parameters based on treatment with LJPC-501
Time frame: Hour 24 and Hour 48
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 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.
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing LJPC-501 (angiotensin II) in people with Catecholamine-resistant Hypotension (CRH) and Distributive Shock, run by La Jolla Pharmaceutical Company at 2 sites in 2 countries.
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 8 inclusion and 14 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: status not confirmed, as of the sponsor's last update on 9 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 2 sites in Belgium, Lithuania. 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. Some participants in this study may receive a placebo. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Rena Harrigan, MPH (858-207-4264 ext. 1129, rharrigan@ljpc.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of patients who have a >/= 50% reduction in norepinephrine equivalent doses (NED) (time frame: Hour 3). 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 9 Aug 2018.