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

Active, not recruiting

• Conditions: Pancreatitis, Acute

• Registration Number: NCT05955235
• Lead Sponsor: SCM Lifescience Co., LTD.

Brief 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.

Study Timeline

• Study Start: 2019-05-10
• Status Verified: 2023-06
• Study First Submitted: 2023-06-23
• Study First Submitted QC: 2023-07-12
• Study First Posted: 2023-07-21
• Last Update Submitted: 2023-11-22
• Last Update Posted: 2023-11-28
• Primary Completion: 2026-08-20
• Study Completion: 2026-12-31

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 42

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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

Secondary Outcome Measures

Name	Time	Method
Number of occurrences of Abnormal, clinically significant in laboratory results	Up to 5 Years	Perform if necessary.; * Hematology: RBC, Hemoglobin, Hematocrit, Platelet count, WBC with Differential Count; * Chemistry: Na, K, Ca, Cl, BUN, Creatinine, Uric acid, Total bilirubin, Albumin, Total protein, ALT, AST, r-GT, ALP, LDH, glucose, Total cholesterol, Triglyceride, C-reactive protein; * Urinalysis: Protein, Glucose, Urobilinogen, WBC, RBC Blood coagulation test: aPTT, PT
Number of occurrences of Abnormal, clinically significant in Vital Signs	Up to 5 Years	Measure systolic blood pressure, diastolic blood pressure, pulse, and body temperature.

Trial Locations

Locations (6)

Chonnam National University Medical School; 🇰🇷 Gwangju, Korea, Republic of

Soonchunhyang University Hosptial Bucheon; 🇰🇷 Bucheon, Gyenggi-do, Korea, Republic of

Kyungpook National University Chilgok Hospital; 🇰🇷 Daegu, Korea, Republic of

Dongguk University Ilsan Hospital; 🇰🇷 Goyang-si, Korea, Republic of

Inha University Hospital; 🇰🇷 Incheon, Korea, Republic of

Ajou University Hospital; 🇰🇷 Suwon, Korea, Republic of