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Trial record 3 of 15 for:    athos

A Phase 3 Study of LJPC-501 in Patients With Catecholamine-Resistant Hypotension (ATHOS-3)

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ClinicalTrials.gov Identifier: NCT02338843
Recruitment Status : Completed
First Posted : January 14, 2015
Results First Posted : January 17, 2018
Last Update Posted : March 27, 2018
Sponsor:
Information provided by (Responsible Party):
La Jolla Pharmaceutical Company

Tracking Information
First Submitted Date  ICMJE January 1, 2015
First Posted Date  ICMJE January 14, 2015
Results First Submitted Date  ICMJE November 28, 2017
Results First Posted Date  ICMJE January 17, 2018
Last Update Posted Date March 27, 2018
Study Start Date  ICMJE March 2015
Actual Primary Completion Date December 1, 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 15, 2018)
An Increased MAP, Defined as Achievement of a Day 1 MAP at 3 Hours Following the Initiation of Study Drug, of ≥ 75 mmHg OR a 10 mmHg Increase in Baseline MAP [ Time Frame: Hour 3 ]
Response with respect to mean arterial pressure (MAP) at hour 3 after the start of infusion was defined as an increase from baseline of at least 10 mm Hg or an increase to at least 75 mm Hg, without an increase in the dose of background vasopressors.
Original Primary Outcome Measures  ICMJE
 (submitted: January 13, 2015)
Increased mean arterial pressure (MAP) [ Time Frame: Day 1 ]
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE
 (submitted: January 13, 2015)
SOFA Score [ Time Frame: Day 2 ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Phase 3 Study of LJPC-501 in Patients With Catecholamine-Resistant Hypotension
Official Title  ICMJE A Phase 3, Placebo-Controlled, Randomized, Double-Blind, Multi-Center Study of LJPC-501 in Patients With Catecholamine-Resistant Hypotension (CRH)
Brief Summary This is a Phase 3, double-blind, randomized study of LJPC-501 (angiotensin II) in adult patients diagnosed with catecholamine-resistant hypotension (CRH) conducted in multiple centers globally.
Detailed Description

Catecholamine-resistant hypotension (CRH) is an often fatal condition resulting from an underlying cause such as septic shock, inflammation due to trauma, or severe drug reactions. When these conditions occur, most patients will respond to either volume expansion or vasopressor treatment. However, some patients will require excessive doses of vasopressors and will be deemed to be resistant.

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 patients with catecholamine-resistant hypotension (CRH).

This is a multi-site, randomized, double-blind, placebo-controlled study. Adult patients with CRH, who are hospitalized in an ICU setting, may be eligible to participate. Approximately 315 patients will be enrolled.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Catecholamine-resistant Hypotension (CRH)
  • Distributive Shock
  • High Output Shock
  • Sepsis
Intervention  ICMJE
  • Drug: LJPC-501
    Treatment arm
    Other Name: angiotensin II
  • Drug: Placebo
    PBO
    Other Name: 0.9% Sodium Chloride Solution USP
Study Arms  ICMJE
  • Experimental: LJPC-501 (angiotensin II)
    Treatment arm
    Intervention: Drug: LJPC-501
  • Placebo Comparator: Placebo (0.9% sodium chloride solution)
    Placebo arm
    Intervention: Drug: Placebo
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 6, 2017)
344
Original Estimated Enrollment  ICMJE
 (submitted: January 13, 2015)
315
Actual Study Completion Date  ICMJE February 18, 2017
Actual Primary Completion Date December 1, 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.

    1. Central venous oxygen saturation (ScvO2) > 70% (either by oximetry catheter or by central venous blood gas) and central venous pressure (CVP) > 8 mmHg.

      OR

    2. 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.

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Australia,   Belgium,   Canada,   Finland,   France,   Germany,   New Zealand,   Switzerland,   United Kingdom,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02338843
Other Study ID Numbers  ICMJE LJ501-CRH01
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party La Jolla Pharmaceutical Company
Study Sponsor  ICMJE La Jolla Pharmaceutical Company
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: George F Tidmarsh, MD, PhD La Jolla Pharmaceutical Company
PRS Account La Jolla Pharmaceutical Company
Verification Date January 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP