A Study of Auxora in Patients With Acute Pancreatitis and Accompanying SIRS
Status:
Recruiting
Trial end date:
2022-10-01
Target enrollment:
Participant gender:
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.