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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.
Subjects who meet all eligibility criteria for Long Term Follow-Up(LTFU) study participation at the SCM-APT2001 End of Treatment(EOT) visit may continue LTFU for a maximum period of up to 240 weeks post first dose of investigational product. No additional dosing will be administered on this LTFU protocol.
Age
19 - No limit years
Sex
ALL
Healthy Volunteers
No
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
Start Date
May 10, 2019
Primary Completion Date
August 20, 2026
Completion Date
December 31, 2026
Last Updated
November 28, 2023
42
ESTIMATED participants
Not Applicable(Observation Study)
OTHER
Lead Sponsor
SCM Lifescience Co., LTD.
NCT07406698
NCT07171112
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and ConditionsNCT07024199