CM4620 Injectable Emulsion Versus Supportive Care in Patients With Acute Pancreatitis and SIRS

This is an interventional treatment trial for Acute Pancreatitis Read More

Inclusion Criteria:

1. Diagnosis of acute pancreatitis established by the presence of abdominal pain consistent with acute pancreatitis and 1 of the following 2 criteria:

   1. Serum lipase and/or serum amylase > 3 times the upper limit of normal (ULN);
   2. Characteristic findings of acute pancreatitis on abdominal imaging;
2. A SpO2 <96% with a FiO2 of 21% (room air) to 27%, or a SpO2 <97% with a FiO2 ≥28%;

3. Diagnosis of SIRS, defined by the presence of at least 2 of the following 4 criteria:

   1. Temperature < 36°C or > 38°C;
   2. Heart rate > 90 beats/minute;
   3. Respiratory rate >20 breaths/minute or arterial carbon dioxide tension (PaCO2) <32 mmHg;
   4. White blood cell count (WBC) >12,000 mm3, or <4,000 mm3, or > 10% immature (band) forms;
4. No evidence of pancreatic necrosis on contrast-enhanced computed tomography (CECT performed in the 18 hours prior to consent or after consent and before Day 1;
5. Adults ≥ 18 years of age;
6. A female patient of child bearing potential who is sexually active with a male partner must be willing to practice acceptable methods of birth control for 365 days after the last dose of CM4620-IE;
7. A male patient who is sexually active with a female partner of childbearing potential must be willing to practice acceptable methods of birth control for 365 days after the last dose of CM4620-IE and must not donate sperm for 365 days.
8. Willing and able to, or have a legal authorized representative (LAR) that is willing and able to, provide informed consent to participate, and to cooperate with all aspects of the protocol.

Exclusion Criteria:

1. Any concurrent clinical condition that a study physician believes could potentially pose an unacceptable health risk to the patient while involved in the study, including a CV SOFA score of 4 at the time of screening, or may limit expected survival to <6 months;
2. Suspected presence of cholangitis in the judgment of the treating investigator;
3. ERCP performed in the previous 7 days;
4. Any malignancy being treated with chemotherapy or immunotherapy;
5. Any autoimmune disease being treated with immunosuppressive medication or immunotherapy;

6. History of:

   1. Acute pancreatitis with pancreatic necrosis on Contrast-Enhanced Computed Tomography (CECT) of the pancreas;
   2. Chronic pancreatitis, pancreatic necrosis or necrosectomy, or pancreatic enzyme replacement therapy;
   3. Biopsy proven cirrhosis, portal hypertension, hepatic failure/hepatic encephalopathy;
   4. Known hepatitis B or C, or HIV;
   5. History of organ or hematologic transplant;
   6. Resuscitated cardiac arrest, myocardial infarction, revascularization, cardiovascular accident (CVA) in the 30 days prior to Day 1;
7. Current renal replacement therapy;
8. Current known abuse of cocaine or methamphetamine;
9. Known to be pregnant or are nursing;
10. Participated in another study of an investigational drug or therapeutic medical device in the 30 days prior to Day 1;
11. History of allergy to eggs or known hypersensitivity to any components of CM4620-IE.