Expanded Access for LJPC-501

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

• Registration Number: NCT03245528
• Lead Sponsor: La Jolla Pharmaceutical Company

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.

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 Timeline

• Study First Submitted: 2017-08-07
• Study First Submitted QC: 2017-08-07
• Study First Posted: 2017-08-10
• Status Verified: 2018-03
• Last Update Submitted: 2018-03-06
• Last Update Posted: 2018-03-08

Recruitment & Eligibility

• Status: APPROVED_FOR_MARKETING
• Sex: All
• Target Recruitment: Not specified

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 & Design

• Study Type: EXPANDED_ACCESS
• Study Design: Not specified