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    Summary
    EudraCT Number:2015-002448-15
    Sponsor's Protocol Code Number:LJ501-CRH01
    National Competent Authority:Finland - Fimea
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2016-01-27
    Trial results View results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedFinland - Fimea
    A.2EudraCT number2015-002448-15
    A.3Full title of the trial
    A Phase 3, Placebo-Controlled, Randomized, Double-Blind, Multi-Center Study of LJPC-501 in Patients with Catecholamine-Resistant Hypotension (CRH)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    LJPC-501 in Patients with Catecholamine-Resistant Hypotension
    A.3.2Name or abbreviated title of the trial where available
    LJPC-501 in Patients with Catecholamine-Resistant Hypotension
    A.4.1Sponsor's protocol code numberLJ501-CRH01
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT02338843
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorLa Jolla Pharmaceutical Company, Inc.
    B.1.3.4CountryUnited States
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportLa Jolla Pharmaceutical Company, Inc.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationEmas Pharma
    B.5.2Functional name of contact pointClinical
    B.5.3 Address:
    B.5.3.1Street Address63-65 Knowl Piece, Wilbury Way
    B.5.3.2Town/ cityHitchin
    B.5.3.3Post codeSG4 0TY
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number4401642424400
    B.5.5Fax number4401462600453
    B.5.6E-mailClinicalTrials@emaspharma.com
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation No
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.2Product code LJPC-501
    D.3.4Pharmaceutical form Concentrate for solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNAngiotensin II acetate
    D.3.9.2Current sponsor codeLJPC-501
    D.3.9.4EV Substance CodeAS1
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number2.5
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboSolution for infusion
    D.8.4Route of administration of the placeboIntravenous use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Catecholamine-Resistant Hypotension
    E.1.1.1Medical condition in easily understood language
    Low blood pressure that is resistant to correction by treatment with catecholamines.
    E.1.1.2Therapeutic area Body processes [G] - Circulatory and Respiratory Physiological Phenomena [G09]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 19.0
    E.1.2Level LLT
    E.1.2Classification code 10049705
    E.1.2Term Acute hypotension
    E.1.2System Organ Class 100000004866
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To compare the effect of LJPC-501 infusion, versus placebo, on mean arterial pressure (MAP) in patients with catecholamine-resistant hypotension (CRH).
    E.2.2Secondary objectives of the trial
    Secondary
    • To compare change in Sequential Organ Failure Assessment (SOFA) scores with LJPC-501 infusion, versus placebo
    • To establish the safety and tolerability of LJPC-501 and compare to placebo in patients with CRH
    Exploratory
    • To compare change in heart rate with LJPC-501 infusion, versus placebo
    • To compare change in catecholamine dosing with LJPC-501 infusion, versus placebo
    • To compare mortality with LJPC-501 infusion, versus placebo.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Adult patients ≥ 18 years of age with CRH, defined as those who require a total sum catecholamine dose of >0.2 mcg/kg/min for a minimum of 6 hours and a maximum of 48 hours, to maintain a MAP between 55-70 mmHg.
    2. Patients are required to have central venous access and an arterial line present, and these are expected to remain present for at least the initial 48 hours of study.
    3. Patients are required to have an indwelling urinary catheter present, and it is expected to remain present for at least the initial 48 hours of study.
    4. Patients must have received at least 25 mL/kg of crystalloid or colloid equivalent over the previous 24-hour period, and be adequately volume resuscitated in the opinion of the treating investigator.
    5. Patients must have clinical features of high-output shock by meeting one of the following criteria.
    a. Central venous oxygen saturation (ScvO2) > 70% (either by oximetry catheter or by central venous blood gas) and central venous pressure (CVP) > 8 mmHg.
    OR
    b. Cardiac Index (CI) > 2.3 L/min/1.73 m2. Patient must meet 5a or 5b to be eligible.
    6. Patient or legal surrogate is willing and able to provide written informed consent and comply with all protocol requirements.
    E.4Principal exclusion criteria
    1. Patients who are < 18 years of age.
    2. Any patient with burns covering > 20% of total body surface area (TBSA).
    3. Patients with a Cardiovascular (CV) SOFA score ≤ 3.
    4. Patients diagnosed with acute occlusive coronary syndrome requiring intervention.
    5. Patients on veno-arterial (VA) ECMO.
    6. Patients who have been on ECMO for less than 12 hours.
    7. Patients in liver failure with a Model for End-Stage Liver Disease (MELD) score of ≥ 30.
    8. Patients with a history of asthma or who are currently experiencing bronchospasm requiring the use of inhaled bronchodilators, if not mechanically ventilated.
    9. Patients with acute mesenteric ischemia or a history of mesenteric ischemic.
    10. Patients with a history of, presence of, or highly-suspected of having an aortic dissection or abdominal aortic aneurysm.
    11. Patients requiring more than 500 mg daily of hydrocortisone or equivalent glucocorticoid medication as a standing dose.
    12. Patients with Raynaud’s phenomenon, systemic sclerosis or vasospastic disease.
    13. Patients with an expected lifespan of < 12 hours.
    14. Patients with active bleeding AND an anticipated need (within 48 hours of initiation of the study) for transfusion of > 4 units of packed red blood cells.
    15. Patients with active bleeding AND hemoglobin < 7g/dL or any other condition that would contraindicate serial blood sampling.
    16. Patients with an absolute neutrophil count (ANC) of <
    1000 cells/mm3.
    17. Patients with a known allergy to mannitol.
    18. Patients who are current participating in another interventional clinical trial.
    19. Patients who are known to be pregnant at the time of Screening
    E.5 End points
    E.5.1Primary end point(s)
    To compare the effect of LJPC-501 infusion on mean arterial pressure (MAP) in patients with catecholamine- resistant hypotension (CRH). The primary efficacy endpoint is the proportion of patients with a MAP of 75 mmHg or greater or a 10 mmHg increase in baseline MAP at Hour 3.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Patients will be monitored for hemodynamic vital signs, i.e., Heart Rate (HR) and Mean Arterial Pressure (MAP) at Screening, -30, -15, and 0 minutes or just prior to initiation of study drug dosing, on Day 1 prior to every dose titration and minimally every 15 minutes during hours 0 – 3:15, and prior to any dose adjustments and minimally hourly thereafter beginning at Day 1 at hour 4 through Day 2 at 48 hours. During the first 3 hours of study drug dosing, MAP should be measured in triplicate, at least 1 minute apart and averaged to determine the current MAP for
    dose titrations. Evaluation of MAP will continue once daily on Days 3-7.
    E.5.2Secondary end point(s)
    To compare change in Sequential Organ Failure Assessment (SOFA) scores.

    To establish the safety and tolerability of LJPC-501 and compare to placebo in patients with CRH.
    E.5.2.1Timepoint(s) of evaluation of this end point
    The change in total SOFA score between Baseline and hour 48 including a separate analysis of the CV SOFA score are secondary efficacy endpoints. The total SOFA is the sum of the 6 individual SOFA item scores including CV . The baseline SOFA will be the last measure reported for each of the SOFA items prior to initiating study drug. The hour 48 measures will be the outcome reported at the hour 48 assessment.
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response Yes
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group Yes
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo Yes
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial1
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned4
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA40
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Australia
    Belgium
    Canada
    Finland
    France
    Germany
    New Zealand
    Switzerland
    United Kingdom
    United States
    E.8.7Trial has a data monitoring committee Yes
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    End of study will be the last visit of the last subject.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years0
    E.8.9.1In the Member State concerned months6
    E.8.9.1In the Member State concerned days31
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months6
    E.8.9.2In all countries concerned by the trial days7
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1Number of subjects for this age range: 0
    F.1.1.1In Utero No
    F.1.1.1.1Number of subjects for this age range: 0
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.2.1Number of subjects for this age range: 0
    F.1.1.3Newborns (0-27 days) No
    F.1.1.3.1Number of subjects for this age range: 0
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.4.1Number of subjects for this age range: 0
    F.1.1.5Children (2-11years) No
    F.1.1.5.1Number of subjects for this age range: 0
    F.1.1.6Adolescents (12-17 years) No
    F.1.1.6.1Number of subjects for this age range: 0
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 265
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 50
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations Yes
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception No
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation Yes
    F.3.3.6Subjects incapable of giving consent personally Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    In the event the patient is admitted unconscious, the patient will not be able to consent themselves.
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state50
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 200
    F.4.2.2In the whole clinical trial 315
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    Following completion of the trial patients will continue with the site's normal standard care and follow-up.
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2016-02-18
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2015-12-14
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2016-12-08
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