Safety and Efficacy of SCM-AGH in Patients With Moderate to Severe Acute Pancreatitis (NCT04189419) | Clinical Trial Compass
CompletedPhase 1/2
Safety and Efficacy of SCM-AGH in Patients With Moderate to Severe Acute Pancreatitis
South Korea36 participantsStarted 2019-08-12
Plain-language summary
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
Who can participate
Age range19 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
ā. \>=19 years of age
ā. Patient with acute pancreatitis with organ failure which has been determined as severe acute pancreatitis prior to assignment(randomization) (1) Organ failure: 2 points of Modified Marshall Score in one or more of the respiratory system, renal system and cardiovascular system (2) Acute pancreatitis: at least 2 of the following 3 conditions are met
ā. Increased blood level of pancreatic enzyme (amylase or lipase \>= three times of upper limit of normal)
ā. Finding acute pancreatitis in imaging test (contrast enhanced computerized tomography, abdominal magnetic resonance imaging, or abdominal sonography) (3) Severe: at least 1 of following organ failures lasting for \> 48 hours according to the 2012 Atlanta Classification
ā. Patient who or whose representative voluntarily agrees to participate in this study and has given a written informed consent
ā. Organ failure: 2 points of Modified Marshall Score in one or more of the respiratory system, renal system and cardiovascular system
ā. CTSI: Sum of Balthazar grade and Necrosis score. CTSI 1-3: Mild / CTSI 4-6: Moderate / CTSI 7-10: Severe
Exclusion criteria
ā. Patient with allergic or hypersensitivity reaction to investigational product, drug of similar class or ingredients (bovine serum, dimethyl sulfoxide)
ā. Patient who cannot undergo contrast-enhanced computerized tomography due to allergic reaction to contrast medium
What they're measuring
1
The change from baseline in modified Marshall score on Day 7 for organ failure subject