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

• Status: Completed
• Trial end date: 2019-04-30
• Target enrollment: 0
• Participant gender: All

Summary

This open-label, dose-response study will evaluate the safety and efficacy of CM4620-IE in patients with acute pancreatitis and accompanying SIRS. The study will consist of two phases. The first phase will consist of 2 cohorts that will be enrolled concurrently. Cohort 1 will consist of 4 female patients who will be randomized 3:1 to receive CM4620-IE plus supportive care versus supportive care alone. Cohort 2 will consist of 4 male patients who will be randomized 3:1 to receive CM4620-IE plus supportive care versus supportive care alone. The second phase will consist of 2 cohorts. Cohort 3 will consist of 8 female patients who will be randomized 3:1 to receive CM4620-IE plus supportive care versus supportive care alone. Cohort 4 will consist of 8 male patients who will be randomized 3:1 to receive CM4620-IE plus supportive care versus supportive care alone.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: CalciMedica, Inc.

Criteria

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.