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Expanded Access for LJPC-501

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ClinicalTrials.gov Identifier: NCT03245528
Expanded Access Status : Approved for marketing
First Posted : August 10, 2017
Last Update Posted : March 8, 2018
Sponsor:
Information provided by (Responsible Party):
La Jolla Pharmaceutical Company

Study Description
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Brief Summary:
The primary objective of the study is to provide access to LJPC-501 for distributive shock patients who remain hypotensive despite receiving fluid and vasopressor therapy.

Condition or disease Intervention/treatment
Catecholamine Resistant Hypotension (CRH) Distributive Shock High Output Shock Sepsis Vasodilatory Shock Drug: LJPC-501

Detailed Description:

Primary Objective

The primary objective of the study is to provide access to LJPC-501 for distributive shock patients who remain hypotensive despite receiving fluid and vasopressor therapy.

Secondary Objective

The secondary objective of the study is to assess the safety of LJPC-501.


Study Design
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Study Type : Expanded Access
Expanded Access Type : Treatment IND/Protocol
Official Title: Expanded Access for LJPC-501

Resource links provided by the National Library of Medicine


Interventions
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Intervention Details:
  • Drug: LJPC-501
    angiotensin II
Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Criteria

Inclusion Criteria:

  • Patients must be adults ≥ 18 years of age who remain hypotensive despite fluid therapy and vasopressor therapy and who received or are receiving a total sum norepinephrine (NE) equivalent unit dose of > 0.2 µg/kg/min for at least 2 hours prior to LJPC-501 infusion.
  • Patients must have central venous access and an arterial line present, which is expected to remain for the duration of the LJPC-501 infusion.
  • Patients must be adequately volume resuscitated in the opinion of the treating investigator.
  • Patients must have clinical features of distributive shock documented by either estimated or measured CI > 2.3 L/min/m^2 determined by echocardiogram or another cardiac output monitoring modality OR a concurrent CVP > 8 mmHg and ScvO2 > 70%.
  • Patient or legal surrogate is willing and able to provide informed consent per local guidance and patient/legal surrogate is willing to comply with all protocol requirements.

Exclusion Criteria:

  • Patients with a MAP > 80 mmHg.
  • Patients diagnosed with acute occlusive coronary syndrome requiring intervention.
  • Patients who have been on ECMO < 6 hours.
  • Patients in liver failure with a MELD score ≥ 30.
  • Patients not mechanically ventilated with a history of asthma or who are currently experiencing bronchospasm requiring the use of inhaled bronchodilators.
  • Patients with acute mesenteric ischemic or history of mesenteric ischemia.
  • Patients with Raynaud's phenomenon, systemic sclerosis, or vasospastic disease.
  • Patients with an expected lifespan of < 24 hours.
  • Patients with active bleeding AND an anticipated need for transfusion of > 4 units PRBCs within 48 hours of the initiation of LJPC-501.
  • Patients with active bleeding AND hemoglobin < 7 g/dL.
  • Patients with an ANC < 500 cells/mm^3.
  • Patients with a known allergy to mannitol.
  • Patients who are currently participating in an investigational interventional trial.
  • Women who are known to be pregnant at the time of Screening or have a positive serum or urine β-hCG, if of childbearing potential.
Contacts and Locations
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No Contacts or Locations Provided
More Information
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Responsible Party: La Jolla Pharmaceutical Company
ClinicalTrials.gov Identifier: NCT03245528     History of Changes
Other Study ID Numbers: LJ501-EAP01
First Posted: August 10, 2017    Key Record Dates
Last Update Posted: March 8, 2018
Last Verified: March 2018

Additional relevant MeSH terms:
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Shock
Hypotension
Pathologic Processes
Vascular Diseases
 Cardiovascular Diseases
Angiotensin II
Giapreza
Vasoconstrictor Agents