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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT05955235
Other study ID # APT2001-LTFU
Secondary ID
Status Active, not recruiting
Phase
First received
Last updated
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
Health authority
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
Accepts healthy volunteers
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

Study Design


Related Conditions & MeSH terms


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
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