Expanded Access for LJPC-501

NCT03245528 | Unknown

• 1 other identifier: LJ501-EAP01
• Study Type: expanded_access
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Catecholamine Resistant Hypotension (CRH); Distributive Shock; High Output Shock; Sepsis; Vasodilatory Shock

Interventions

LJPC-501 DRUG

angiotensin II

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• La Jolla Pharmaceutical Company: lead

MeSH Terms

Conditions

Sepsis

Interventions

Angiotensin I

Condition Hierarchy (Ancestors)

Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Angiotensins; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Neuropeptides; Peptides; Amino Acids, Peptides, and Proteins; Oligopeptides; Nerve Tissue Proteins; Proteins; Autacoids; Inflammation Mediators; Biological Factors

Study Design

• Study Type: expanded access
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 7, 2017
• First Posted: August 10, 2017
• Last Updated: March 8, 2018

Record last verified: 2018-03