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
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Condition or disease | Intervention/treatment |
---|---|
Catecholamine Resistant Hypotension (CRH) Distributive Shock High Output Shock Sepsis Vasodilatory Shock | Drug: LJPC-501 |
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 |
Official Title: | Expanded Access for LJPC-501 |

- Drug: LJPC-501
angiotensin II

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
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.
Responsible Party: | La Jolla Pharmaceutical Company |
ClinicalTrials.gov Identifier: | NCT03245528 |
Other Study ID Numbers: |
LJ501-EAP01 |
First Posted: | August 10, 2017 Key Record Dates |
Last Update Posted: | March 8, 2018 |
Last Verified: | March 2018 |
Hypotension Shock Pathologic Processes Vascular Diseases |
Cardiovascular Diseases Angiotensin II Giapreza Vasoconstrictor Agents |