Expanded Access for LJPC-501
Overview
Tab Title Description
Study type
InterventionalDescribes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
Study IDs
Site IRB
- Scottsdale/Phoenix, Arizona: 17-007836
NCT ID: NCT03245528
Sponsor Protocol Number: LJ501-EAP01
About this study
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.
Participation eligibility
Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.
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.
Participating Mayo Clinic locations
Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.
| Mayo Clinic Location |
Status |
|
Scottsdale/Phoenix, Ariz.
Mayo Clinic principal investigator Ayan Sen, M.D. |
Closed for enrollment |
|
More information
Publications
Publications are currently not available