NCT05955235

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

• Status: Active Not Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 42 (estimated)
• Sponsor: SCM Lifescience Co., LTD. · Industry
• Sex: All
• Age: 19 Years
• Healthy volunteers: —

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.

Detailed 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.

Conditions

• Pancreatitis, Acute

Interventions

Type	Name	Description
OTHER	Not Applicable(Observation Study)	Not Applicable(Observation Study)

Timeline

• Start date: 2019-05-10
• Primary completion: 2026-08-20
• Completion: 2026-12-31
• First posted: 2023-07-21
• Last updated: 2023-11-28

Locations

6 sites across 1 country: South Korea