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Safety and Efficacy of SCM-AGH in Patients With Moderate to Severe Acute Pancreatitis

NCT04189419 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 36

Last updated 2023-06-08

No results posted yet for this study

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

Conditions

  • Pancreatitis, Acute

Interventions

BIOLOGICAL

SCM-AGH

SCM-AGH will be administrated once a day for 3 days(D0, D1 and D2).

OTHER

Placebo

Placebo will be administrated once a day for 3 days(D0, D1 and D2).

Sponsors & Collaborators

  • SCM Lifescience Co., LTD.

    lead INDUSTRY

Principal Investigators

  • Yun Nah Lee · Soon Chun Hyang University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
19 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-08-12
Primary Completion
2022-01-14
Completion
2022-03-15

Countries

  • South Korea

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04189419 on ClinicalTrials.gov