Health Condition 1: K859- Acute pancreatitis, unspecified
Conditions
Interventions
Intervention1: CM-4620 Injectable Emulsion (Auxora): Patients randomized to receive Auxora will 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
Sponsors
CalciMedica, Inc.
JSS Medical Research Asia Pacific Private Limited
Eligibility
Inclusion criteria
Inclusion criteria: Inclusion criteria: All of the following must be met for a patient to be randomized into the study: 1. The diagnosis of AP has been established by the presence of abdominal pain consistent with AP together with at least 1 of the following 2 criteria: a. Serum lipase > 3 times the upper limit of normal (ULN); b. Characteristic findings of AP on abdominal imaging; 2. The diagnosis of SIRS has been established by the presence of at least two of the following four criteria: a. Temperature 38°C; b. Heart rate > 90 beats/minute; c. Respiratory rate >20 breaths/minute or arterial carbon dioxide tension (PaCO2) d. White blood cell count (WBC) >12,000 mm3, or 10% immature (band) forms; 3. At least one of the following criteria is also present: a. 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; b. Abdominal examination documenting either abdominal guarding or rebound tenderness; c. Hematocrit =44% for men or =40% for women; 4. The patient is = 18 years of age; 5. 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; 6. 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; 7. 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; 8. 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.
Exclusion criteria
Exclusion criteria: Patients with any of the following conditions or characteristics must be excluded from randomizing: 1. Expected survival 2. Suspected presence of cholangitis in the judgment of the treating physician; 3. The patient has a known history of: a. Organ or hematologic transplant; b. HIV, hepatitis B, or hepatitis C infection; c. Chronic pancreatitis; 4. Current treatment with: a. Chemotherapy; b. Immunosuppressive medications or immunotherapy Chemotherapy - • Cyclosporine, Tacrolimus, • Sirolimus, Everolimus, • Azathioprine, • Cyclosphosphamide, • Methotrexate, • Mycophenolate, • Leflunomide,• Biologics/Monoclonals: abatacept, adalimumab, alemtuzumab, anakinra, basilizimab, belimumab, bevacizumab, brodalumab, canakinumab, certolizumab, cetuximab, clazakizumab, daclizumab, eculizumab, etanercept, golimumab, infliximab, interferon, ixekizumab, muromonab, natalizumab, omalizumab, rituximab, secukinumab, tocilizumab, trastuzumab, ustekinumab, vedolizumab, • Baracitinib • Tofacitinib c. Pancreatic enzyme replacement therapy; d. Hemodialysis or Peritoneal Dialysis; 5. The patient is known to be pregnant or is nursing; 6. The patient has participated in another study of an investigational drug or therapeutic medical device in the 30 days before randomization; 7. Allergy to eggs or known hypersensitivity to any components of study drug.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Time to solid food toleranceTimepoint: Following the start of first Infusion (SFISD) and at each meal time | — |
Secondary
| Measure | Time frame |
|---|---|
| Solid food tolerance at 48 hours, 72 hours, and 96 hours after the SFISD and at discharge • Time to medically indicated discharge • Length of stay in the hospital • Length of stay in the intensive care unit (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 Timepoint: 48 hours, 72 hours and 96 hours | — |
Countries
India, United States of America
Contacts
Public ContactDr Jayashri Krishnan
JSS Medical Research Asia pacific Private Limited
Outcome results
None listed