Status:
COMPLETED
CM4620 Injectable Emulsion Versus Supportive Care in Patients With Acute Pancreatitis and SIRS
Lead Sponsor:
CalciMedica, Inc.
Conditions:
Acute Pancreatitis
Systemic Inflammatory Response Syndrome
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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...
Detailed Description
After review of the efficacy, tolerability and safety data from cohorts 1 and 2 by the sponsor and the United States Food and Drug Administration, the decision was made to continue the low-dose regime...
Eligibility Criteria
Inclusion
- Diagnosis of acute pancreatitis established by the presence of abdominal pain consistent with acute pancreatitis and 1 of the following 2 criteria:
- Serum lipase and/or serum amylase \> 3 times the upper limit of normal (ULN);
- Characteristic findings of acute pancreatitis on abdominal imaging;
- A SpO2 \<96% with a FiO2 of 21% (room air) to 27%, or a SpO2 \<97% with a FiO2 ≥28%;
- Diagnosis of SIRS, defined by the presence of at least 2 of the following 4 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;
- 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;
- Adults ≥ 18 years of age;
- 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;
- 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.
- 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
- 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;
- Suspected presence of cholangitis in the judgment of the treating investigator;
- ERCP performed in the previous 7 days;
- Any malignancy being treated with chemotherapy or immunotherapy;
- Any autoimmune disease being treated with immunosuppressive medication or immunotherapy;
- History of:
- Acute pancreatitis with pancreatic necrosis on Contrast-Enhanced Computed Tomography (CECT) of the pancreas;
- Chronic pancreatitis, pancreatic necrosis or necrosectomy, or pancreatic enzyme replacement therapy;
- Biopsy proven cirrhosis, portal hypertension, hepatic failure/hepatic encephalopathy;
- Known hepatitis B or C, or HIV;
- History of organ or hematologic transplant;
- Resuscitated cardiac arrest, myocardial infarction, revascularization, cardiovascular accident (CVA) in the 30 days prior to Day 1;
- Current renal replacement therapy;
- Current known abuse of cocaine or methamphetamine;
- Known to be pregnant or are nursing;
- Participated in another study of an investigational drug or therapeutic medical device in the 30 days prior to Day 1;
- History of allergy to eggs or known hypersensitivity to any components of CM4620-IE.
Key Trial Info
Start Date :
March 12 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 30 2019
Estimated Enrollment :
21 Patients enrolled
Trial Details
Trial ID
NCT03401190
Start Date
March 12 2018
End Date
April 30 2019
Last Update
December 7 2021
Active Locations (9)
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1
Detroit Receiving Hospital (Wayne State)
Detroit, Michigan, United States, 48201
2
Henry Ford Hospital
Detroit, Michigan, United States, 48202
3
Sinai-Grace Hospital (Wayne State)
Detroit, Michigan, United States, 48235
4
Hennepin County Medical Center
Minneapolis, Minnesota, United States, 55415