CM4620 Injectable Emulsion Versus Supportive Care in Patients With Acute Pancreatitis and SIRS (NCT03401190) | Clinical Trial Compass
CompletedPhase 2
CM4620 Injectable Emulsion Versus Supportive Care in Patients With Acute Pancreatitis and SIRS
United States21 participantsStarted 2018-03-12
Plain-language 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 4 female and 4 male patients (cohorts 1 and 2, respectively), enrolled concurrently, randomized in a 3:1 ratio to receive CM4620-IE plus standard of care versus standard of care alone. Planned doses for first phase will be CM4620-IE 1.0 mg/kg on Day 1 and then 1.4 mg/kg on Days 2 - 4.
The second phase will consist of 8 female and 8 male patients (cohorts 3 and 4, respectively), enrolled concurrently, randomized in a 3:1 ratio to receive CM4620-IE plus standard of care versus standard of care alone. Planned doses for second phase will be CM4620-IE 2.08 mg/kg on Days 1 and 2 and then 1.6 mg/kg on Days 3 and 4. Dose escalation to second phase would only occur if needed for efficacy reasons and if no events suggesting a safety signal would occur with higher dosing.
The study is not powered for the analysis of study data with inferential statisitcs as the primary purpose of the study is to explore what endpoints would be most appropriate for future trials.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. 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:
✕. 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;
What they're measuring
1
The Safety and Tolerability of CM4620-IE in Patients With Acute Pancreatitis and Accompanying Systemic Inflammatory Response Syndrome (SIRS) or Hypoxemia.