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Clinical Trials in South Korea / NCT05955235
Active, not recruiting Observational

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

NCT05955235 · tracked via the Priya Life Science South Korea tracker
Sponsor
SCM Lifescience Co., LTD
Phase
Observational
Started
2019-05-10
Last updated
2023-11-28

Condition(s) studied

Pancreatitis, Acute

Investigational drug(s) / intervention(s)

Not Applicable(Observation Study)

Not Applicable(Observation Study): Not Applicable(Observation Study)

Study 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.

Eligibility

Sex
ALL
Min age
19 Years
Max age
—
Healthy volunteers
No
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

Primary outcome measure(s)

  • Long-term safety assessment — Up to 5 Years
    Ratio and number of cases for subjects who have experienced SAE(Serious Adverse Event).
  • Mortality — Up to 5 Years
    Ratio of subjects who died during long-term safety follow-up
  • Ratio of subjects with malignant tumors formed during the long-term safety follow-up period — Up to 5 Years
    The number, ratio, and number of cases of malignant tumor formation

Trial sites (6)

FacilityCityRegionStatus
Soonchunhyang University Hosptial Bucheon Bucheon-si Gyenggi-do
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
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05955235 on ClinicalTrials.gov ↗ ← All trials in South Korea