Auxora for Acute Pancreatitis
(CARPO Trial)

Recruiting in Palo Alto (17 mi)

+38 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: CalciMedica, Inc.

Prior Safety Data

Trial Summary

What is the purpose of this trial?

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 necessitating continued hospitalization.

Research Team

Sudarshan Hebbar, MD

Principal Investigator

CalciMedica, Inc.

Eligibility Criteria

This trial is for adults with acute pancreatitis and SIRS, confirmed by specific lab tests, imaging, and symptoms. Participants must not have chronic pancreatitis or a history of certain pancreatic conditions. They should be free from severe infections like HIV/hepatitis, not on dialysis or recent other trials, and willing to use birth control if applicable.

Inclusion Criteria

Heart rate > 90 beats/minute;

White blood cell count (WBC) >12,000 mm3, or <4,000 mm3, or > 10% immature (band) forms;

I have been diagnosed with acute pancreatitis.

See 14 more

Exclusion Criteria

I am currently undergoing treatment.

I have had an organ or bone marrow transplant.

I do not have HIV, hepatitis B, or hepatitis C.

See 11 more

Treatment Details

Interventions

CM-4620 Injectable Emulsion or CM-4620-IE (Anti-inflammatory agent)
Placebo (Other)

Trial OverviewThe study compares Auxora at different doses against a placebo in patients with acute pancreatitis accompanied by SIRS. It's double-blind (neither doctors nor patients know who gets what), involving three daily infusions over three days while hospitalized.

Participant Groups

4Treatment groups

Active Control

Placebo Group

Group I: 0.5 mg/kg (0.3125 mL/kg)Active Control1 Intervention

administered intravenously over 4 hours at a constant rate of infusion. They will be administered every 24 hours (±1 hours) for three consecutive days for a total of 3 doses.

Group II: 2.0 mg/kg (1.25 mL/kg)Active Control1 Intervention

administered intravenously over 4 hours at a constant rate of infusion. They will be administered every 24 hours (±1 hours) for three consecutive days for a total of 3 doses.

Group III: 1.0 mg/kg (0.625 mL/kg)Active Control1 Intervention

administered intravenously over 4 hours at a constant rate of infusion. They will be administered every 24 hours (±1 hours) for three consecutive days for a total of 3 doses.

Group IV: Placebo (1.25, 0.625, or 0.3125 mL/kg)Placebo Group1 Intervention

patients randomized to placebo will receive one of three following volumes (1.25 mL/kg, 0.625 mL/kg, and 0.3125 mL/kg. although three volumes - all patients randomized to placebo will be analyzed together as one arm. administered intravenously over 4 hours at a constant rate of infusion. They will be administered every 24 hours (±1 hours) for three consecutive days for a total of 3 doses.