Sponsor: CalciMedica, Inc. | Status: Recruiting
Start Date: 03/02/2023 | End Date: -
Principal Investigator(s)
Richard Wilkerson
Secondary Investigator(s)
Description:
Study Treatments
Approximately 216 patients with acute pancreatitis (AP) and accompanying systemic inflammatory response syndrome (SIRS) will be randomized at into four groups on a 1:1:1:1 basis, resulting in 54 patients randomized into each group at approximately 30 sites.Patients randomized to receive Auxorawill receive one of three dose levels, 2.0 mg/kg (1.25 mL/kg), 1.0 mg/kg (0.625 mL/kg), and 0.5 mg/kg (0.3125 mL/kg), or placebo every 24 hours (±1 hour) for three consecutive days for a total of three infusions. Auxora will be administered intravenously as a continuous infusion over 4 hours via a bag and tubing compatible with lipid emulsions and using a 1.2-micron filter. Patients will remain hospitalized as per standard of care and once discharged will be asked to complete a daily meal diary and return for a Day 30 safety assessment.
Primary Endpoint
Time to solid food tolerance
Secondary Endpoints
Solid food tolerance at 48 hours, 72 hours, and 96 hours after the Start of First Infusion of Study Drug (SFISD) and at discharge
Time to medically indicated discharge
Length of stay in the hospital
Length of stay in the ICU for patients admitted to the ICU
Re-hospitalization for AP by Day 30
Change in severity of AP by CTSI score from screening to Day 30
Development of pancreatic necrosis ≥30% and >50%
The persistence of SIRS ≥48 hours after the SFISD
Incidence, severity, and duration of organ failure
Mortality by Day 30
Change in pain score and opioid use
Keywords: CARPO, pancreatitis