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

Who is this study for? Patients with acute pancreatitis and accompanying systemic inflammatory response syndrome
What treatments are being studied? CM-4620 Injectable Emulsion or CM-4620-IE
Status: Recruiting
Location: See all (29) locations...
Intervention Type: Drug, Other
Study Type: Interventional
Study Phase: Phase 2
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 necessitating continued hospitalization.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: No
View:

• All of the following must be met for a patient to be randomized into the study:

• The diagnosis of acute pancreatitis has been established by the presence of abdominal pain consistent with acute pancreatitis together with at least 1 of the following 2 criteria:

• Serum lipase > 3 times the upper limit of normal (ULN);

• Characteristic findings of acute pancreatitis on abdominal imaging;

• The diagnosis of SIRS has been established by the presence of at least two of the following four criteria:

• Temperature < 36°C or > 38°C;

• Heart rate > 90 beats/minute;

• Respiratory rate >20 breaths/minute or arterial carbon dioxide tension (PaCO2) <32 mmHg;

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

• At least one of the following criteria is also present:

• A peripancreatic fluid collection or a pleural effusion on a contrast-enhanced computed tomography (CECT) performed in the 24 hours before Consent or after Consent and before Randomization;

• Abdominal examination documenting either abdominal guarding or rebound tenderness;

• Hematocrit ≥44% for men or ≥40% for women;

• The patient is ≥ 18 years of age;

• Lack of pancreatic necrosis, pancreatic calcifications, pancreatic pseudocysts and no evidence for previous necrosectomy or pancreatic surgery identified by CECT performed in the 24 hours before Consent or after Consent and before Randomization;

• A female patient of childbearing potential who is sexually active with a male partner is willing to practice acceptable methods of birth control for 180 days after the last dose of study drug. A female patient must not attempt to become pregnant for 180 days;

• A male patient who is sexually active with a female partner of childbearing potential is willing to practice acceptable methods of birth control for 180 days after the last dose of study drug. A male patient must not donate sperm for 180 days;

• The patient is willing and able to, or has a legal authorized representative (LAR) who is willing and able to, provide informed consent to participate, and to cooperate with all aspects of the protocol.

Locations
United States
California
Long Beach Medical Center
Recruiting
Long Beach
Kaiser Permanente Los Angeles Medical Center
Recruiting
Los Angeles
LA County Hospital - USC
Recruiting
Los Angeles
University of California at Irvine Medical Center
Recruiting
Orange
Harbor UCLA Medical Center
Recruiting
Torrance
Torrance Memorial Medical Center
Recruiting
Torrance
Colorado
National Jewish Health
Withdrawn
Denver
Connecticut
Yale University School of Medicine
Recruiting
New Haven
The Stamford Hospital
Recruiting
Stamford
Florida
Sarasota Memorial Health Care System
Recruiting
Sarasota
Tampa General Hospital
Recruiting
Tampa
Idaho
St. Luke's Regional Medical Center
Recruiting
Boise
Illinois
Northwestern University Hospital
Recruiting
Chicago
Maryland
Lumunis Health Anne Arundel Medical Center
Withdrawn
Annapolis
Michigan
Henry Ford Health System
Recruiting
Detroit
Minnesota
Methodist Hospital
Recruiting
Saint Louis Park
Regions Hospital
Recruiting
Saint Paul
Missouri
University of Missouri School of Medicine
Recruiting
Columbia
Washington University School of Medicine
Recruiting
Saint Louis
New York
Northshore University Hospital
Recruiting
Manhasset
Long Island Jewish Hospital
Recruiting
New Hyde Park
Icahn School of Medicine at Mount Sinai
Recruiting
New York
Ohio
Ohio State University
Recruiting
Columbus
Texas
John Peter Smith Hospital
Recruiting
Fort Worth
Houston Methodist Hospital
Recruiting
Houston
UT Health Houston
Recruiting
Houston
University Health System at San Antonio
Recruiting
San Antonio
Virginia
University of Virginia
Recruiting
Charlottesville
Virginia Commonwealth University
Withdrawn
Richmond
Contact Information
Primary
Liisa Tingue
liisa@calcimedica.com
9725231073
Time Frame
Start Date: March 24, 2021
Estimated Completion Date: September 2024
Participants
Target number of participants: 216
Treatments
Active Comparator: 2.0 mg/kg (1.25 mL/kg)
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.
Active Comparator: 1.0 mg/kg (0.625 mL/kg)
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.
Active Comparator: 0.5 mg/kg (0.3125 mL/kg)
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.
Placebo Comparator: Placebo (1.25, 0.625, or 0.3125 mL/kg)
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.
Sponsors
Leads: CalciMedica, Inc.

This content was sourced from clinicaltrials.gov

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