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 range
19 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. \>=19 years of age
. 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
. Increased blood level of pancreatic enzyme (amylase or lipase \>= three times of upper limit of normal)
. 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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
The change from baseline in modified Marshall score on Day 7 for organ failure subject
. Patient who or whose representative voluntarily agrees to participate in this study and has given a written informed consent
. Organ failure: 2 points of Modified Marshall Score in one or more of the respiratory system, renal system and cardiovascular system
. CTSI: Sum of Balthazar grade and Necrosis score. CTSI 1-3: Mild / CTSI 4-6: Moderate / CTSI 7-10: Severe
Exclusion criteria
. Patient with allergic or hypersensitivity reaction to investigational product, drug of similar class or ingredients (bovine serum, dimethyl sulfoxide)
. Patient who cannot undergo contrast-enhanced computerized tomography due to allergic reaction to contrast medium
. Patient past \>72 hours after the onset of organ failure at assignment (randomization)
. Patient with condition that may develop acute abdominal pain
. Patient with pancreatitis resulting from trauma, surgery, or neoplasm
. Patient with unstable ventilation due to underlying disease other than pancreatitis
. Patient with active infection such as non-pancreatic infection, septicemia, or pneumonia resulting from other disease