CM4620 Injectable Emulsion Versus Supportive Care in Patients With Acute Pancreatitis and SIRS
Status:
Completed
Trial end date:
2019-04-30
Target enrollment:
Participant gender:
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.