A Randomized, Double-Blind, Placebo Controlled Dose-Ranging Study of Auxora in Patients With Acute Pancreatitis and Accompanying

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A Randomized, Double-Blind, Placebo Controlled Dose-Ranging Study of Auxora in Patients With Acute Pancreatitis and Accompanying Systemic Inflammatory Response Syndrome (Protocol # CM4620-203) (CARPO STUDY)

Study Details
Brief Summary:
Approximately 216 patients with acute pancreatitis and accompanying SIRS will be randomized at approximately 30 sites. Patients will be randomly assigned to either Auxora at one of three dose levels or one of three placebo volumes to maintain the double-blind. Study drug infusions will occur every 24 hours for three consecutive days for a total of three infusions. 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. It is recommended that patients randomized in the study should not be discharged from the hospital until solid food is tolerated, abdominal pain has resolved or been adequately controlled, and there is no clinical evidence of infection.
ClinicalTrials.gov NCT number
NCT04681066
Principal Investigator(s)
Maher Madhoun, MD
Sponsor(s)
CalciMedica, Inc
Contact
Carolina Garavito at 203-358-8879
or Officeofresearch@stamhealth.org

Location

  • The Stamford Hospital
    One Hospital Plaza
    Stamford 06904

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