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A Long-term Safety Follow-up Study of SCM-AGH in Patients Who Completed SCM-APT2001 Study

Pancreatitis, Acute Clinical Trial

Official title:
A Long-term Safety Follow-up Study of SCM-AGH in Patients Who Completed SCM-APT2001 Study

Clinical Trial 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.

Clinical Trial Description

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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05955235
Study type Observational
Source SCM Lifescience Co., LTD.
Contact
Status Active, not recruiting
Phase
Start date May 10, 2019
Completion date December 31, 2026
View Details
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