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A Long-term Safety Follow-up Study of SCM-AGH in Patients Who Completed SCM-APT2001 Study
Sponsor: SCM Lifescience Co., LTD.
Summary
This is a long-term safety follow-up study of the Phase I/IIa multicenter study of SCM-AGH in subjects with moderate to severe acute pancreatitis. subjects will be followed up for a maximum period of 240 weeks after the first dose of investigational product. Only subjects previously enrolled in protocol SCM-APT2001 (ClinicalTrials.gov ID: NCT04189419) will be eligible for this long-term follow-up protocol.
Key Details
Gender
All
Age Range
19 Years - Any
Study Type
OBSERVATIONAL
Enrollment
42
Start Date
2019-05-10
Completion Date
2026-12-31
Last Updated
2023-11-28
Healthy Volunteers
Not specified
Conditions
Interventions
Not Applicable(Observation Study)
Not Applicable(Observation Study)
Locations (6)
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
Inha University Hospital
Incheon, South Korea
Ajou University Hospital
Suwon, South Korea