Expanded Access for LJPC-501

Sepsis Clinical Trial

Official title:

Expanded Access for LJPC-501

Clinical Trial Details — Status: Approved for marketing

Administrative data

• NCT number: NCT03245528
• Other study ID #: LJ501-EAP01
• Status: Approved for marketing
• Phase: N/A
• First received: August 7, 2017
• Last updated: March 6, 2018

Study information

• Verified date: March 2018
• Source: La Jolla Pharmaceutical Company
• Contact: n/a
• Is FDA regulated: No
• Study type: Expanded Access

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Approved for marketing
• Enrollment: 0
• Gender: All
• Age group: 18 Years and older

Eligibility

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 ß-hCG, if of childbearing potential.

Related Conditions & MeSH terms

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

Intervention

Drug:
• LJPC-501
angiotensin II

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
La Jolla Pharmaceutical Company