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

SCM Lifescience

Status: Active, not recruiting

Conditions: Pancreatitis, Acute

Treatments: Other: Not Applicable(Observation Study)

Study type: Observational

Funder types: Industry

Identifiers

NCT05955235

APT2001-LTFU

Details and patient eligibility

About

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.

Full 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.

Enrollment: 42 estimated patients

Sex: All

Ages: 19+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Subjects who provide written informed consent
• Subjects who have received at least 1 dose of SCM-AGH in the SCM-APT2001 study

Exclusion criteria

• N/A