This study consists of two phases (Phase I and Phase IIa). Phase IIa will be conducted sequentially after the safety of SCM-AGH is secured in Phase I. * Phase I: Multicenter in Korea, Non-Randomized, Open-label, Single Arm, 3+3 design) for Severe Acute Pancreatitis * Phase II: Multicenter in Korea, Randomized, Double-blind, 2-arm, Placebo-controlled, Parallel arm for Moderate to Severe Acute Pancreatitis
Phase I (Multicenter in Korea, Non-Randomized, Open-label, Single Arm, 3+3 design): Three and up to six patients with severe Acute Pancreatitis are planned to recruit from 12 sites in Korea, but additional three patients can be enrolled by an assessment of Adverse Drug Reaction(ADR) from first three subjects . Subjects will be administered with SCM-AGH as an intravenous (IV) infusion once a day for 3 days. Efficacy and safety are assessed daily for the first week, and then weekly on 3 occasions (Day 14, 21, and 28). Survival is followed up until Day 90. Phase II (Multicenter in Korea, Randomized, Double-blind, 2-arm, Placebo-controlled, Parallel arm): Eligible patients will be randomized to the SCM-AGH group or placebo group at 1:1 ratio. Total 36 patients with Moderate to Severe Acute Pancreatitis are planned to be enrolled from 12 sites in Korea. Subjects will receive SCM-AGH on Day 0, 1, and 2. Existing standard of care is permitted. Efficacy and safety are assessed daily for the first week, and then weekly on 3 occasions (Day 14, 21, and 28). Survival is followed up until Day 90.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
36
Soonchunhyang University Hosptial Bucheon
Bucheon-si, Gyenggi-do, South Korea
Kyungpook National University Chilgok Hospital
Daegu, South Korea
Dongguk University Ilsan Hospital
Goyang-si, South Korea
Chonnam National University Medical School
Gwangju, South Korea
The change from baseline in modified Marshall score on Day 7 for organ failure subject
The modified Marshall score is the scoring system to define the organ failure. The score is based on three different scores, one each for the respiratory, cardiovascular and renal. the modified Marshall score is \>2 through the respiratory, renal or cardiovascular system, it is called organ failure.
Time frame: Day 7
The change from baseline in CTSI Score on Day 28
CTSI is scoring system to define the severity of acute pancreatitis. (4-6: Moderate, 7-10: Severe)
Time frame: Day 28 for CTSI Subject
Percentage of subjects whose organ failure was resolved at 3 days, 7 days, 14 days and 28 days
Time frame: Day 3, Day 7, Day 14 and Day 28 or the day of discharge
The change from baseline in modified Marshall score at each assessment point up to Day 28
Time frame: Day 1, Day 2, Day 3, Day 4, Day 5, Day 6, Day 7, Day 14, Day 21, Day 28
The change from baseline in sequential organ failure assessment (SOFA) at each assessment point up to Day 28
SOFA score is used to track a person's status during the stay in an intensive care unit (ICU) to determine the extent of a person's organ function or rate of failure. The score is based on six different scores, one each for the respiratory, cardiovascular, hepatic, coagulation, renal and neurological systems.
Time frame: Day 1, Day 2, Day 3, Day 4, Day 5, Day 6, Day 7, Day 14, Day 21, Day 28 or the day of discharge
Duration of Systemic inflammatory response syndrome (SIRS)
Time frame: Day 0, Day 1, Day 2, Day 3, Day 4, Day 5, Day 6, Day 7, Day 14, Day 21, Day 28 or the day of discharge
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Inha University Hospital
Incheon, South Korea
Ajou University Hospital
Suwon, South Korea
Wonju Severance Christian Hospital
Wŏnju, South Korea
Time to resolution of organ failure
The modified marshall score is 0 or 1 for all organ in respiratory, cardiovascular and renal.
Time frame: Day 1, Day 2, Day 3, Day 4, Day 5, Day 6, Day 7, Day 14, Day 21, Day 28
The change from baseline value of C-Reactive Protein(CRP) which is inflammatory marker on Day 1, 2, 3, 5, 7, and 14
Time frame: Day 1, Day 2, Day 3, Day 5, Day 7, Day 14
Change from baseline in inflammatory markers(change of Tumor Necrosis Factor(TNF)-α, interleukin(IL)-6, TGF-b1, CCL2 and Lymphocyte count ratio) on Day 1, 2, 3, 5, 7, and 14
Time frame: Day 1, Day 2, Day 3, Day 5, Day 7, Day 14
Duration of intensive care unit (ICU) stay
Number of days for stay duration at ICU. The duration is from the day of hospitalization to day of discharge.
Time frame: Day 28 or the day of discharge
The change from baseline in Computed Tomography Severity Index(CTSI) on Day 28
CTSI is the sum of Balthazar grade and necrosis score. The scoring is defined by evaluation of abdominal Computed Tomography(CT).
Time frame: Day 28 or the day of discharge
Incidence of pancreatic complication
Pancreatic complication will be evaluated by abdominal CT.
Time frame: Day 28 or the day of discharge
Requirement of drainage or surgery
Requirement of drainage due to intra-abdominal catastrophe or necrosis and surgery due to hemorrhage, perforation or abdominal compartment syndrome will be evaluated until Day 28.
Time frame: Day 28 or the day of discharge
Rate of infection
The even of infection such as infected pancreatic necrosis, bacteremia and pneumonia. The several tests for diagnosis can be conducted per investigator's decision.
Time frame: Day 28 or the day of discharge
Mortality on Day 28 and 90
Time frame: Day 28 or the day of discharge and Day 90