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 Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05955235
• Other study ID #: APT2001-LTFU
• Status: Active, not recruiting
• Start date: May 10, 2019
• Est. completion date: December 31, 2026

Study information

• Verified date: June 2023
• Source: SCM Lifescience Co., LTD.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 42
• Est. completion date: December 31, 2026
• Est. primary completion date: August 20, 2026
• Gender: All
• Age group: 19 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Pancreatitis
• Pancreatitis, Acute

Intervention

Other:
• Not Applicable(Observation Study)
Not Applicable(Observation Study)

Locations

Country	Name	City	State
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	Chonnam National University Medical School	Gwangju
Korea, Republic of	Inha University Hospital	Incheon
Korea, Republic of	Ajou University Hospital	Suwon

Sponsors (1)

Lead Sponsor	Collaborator
SCM Lifescience Co., LTD.

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Long-term safety assessment	Ratio and number of cases for subjects who have experienced SAE(Serious Adverse Event).	Up to 5 Years
Primary	Mortality	Ratio of subjects who died during long-term safety follow-up	Up to 5 Years
Primary	Ratio of subjects with malignant tumors formed during the long-term safety follow-up period	The number, ratio, and number of cases of malignant tumor formation	Up to 5 Years
Secondary	Number of occurrences of Abnormal, clinically significant in laboratory results	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	Up to 5 Years
Secondary	Number of occurrences of Abnormal, clinically significant in Vital Signs	Measure systolic blood pressure, diastolic blood pressure, pulse, and body temperature.	Up to 5 Years