Expanded Access for LJPC-501

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.

Study Overview

• Status: Approved for marketing
• Conditions: Sepsis; Vasodilatory Shock; Distributive Shock; High Output Shock; Catecholamine Resistant Hypotension (CRH)
• Intervention / Treatment: 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 Type: Expanded Access
• Expanded Access Type: Treatment IND/Protocol

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Collaborators and Investigators

• Sponsor: La Jolla Pharmaceutical Company

Study record dates

Study Registration Dates

• First Submitted: August 7, 2017
• First Submitted That Met QC Criteria: August 7, 2017
• First Posted (ACTUAL): August 10, 2017

Study Record Updates

• Last Update Posted (ACTUAL): March 8, 2018
• Last Update Submitted That Met QC Criteria: March 6, 2018
• Last Verified: March 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Shock; Hypotension; Vasoconstrictor Agents; Angiotensin II; Giapreza
• Other Study ID Numbers: LJ501-EAP01