Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Not Applicable(Observation Study) | Other | Not Applicable(Observation Study) |
| Measure | Description | Time Frame |
|---|---|---|
| Long-term safety assessment | Ratio and number of cases for subjects who have experienced SAE(Serious Adverse Event). | Up to 5 Years |
| Mortality | Ratio of subjects who died during long-term safety follow-up | Up to 5 Years |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of occurrences of Abnormal, clinically significant in laboratory results | Perform if necessary.
|
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Subjects who have received at least 1 dose of SCM-AGH in the SCM-APT2001 study (ClinicalTrials.gov ID: NCT04189419)
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Soonchunhyang University Hosptial Bucheon | Bucheon-si | Gyenggi-do | 14584 | South Korea | ||
| Kyungpook National University Chilgok Hospital |
Not provided
| ID | Term |
|---|---|
| D010195 | Pancreatitis |
| ID | Term |
|---|---|
| D010182 | Pancreatic Diseases |
| D004066 | Digestive System Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
| Up to 5 Years |
| 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 |
| Daegu |
| South Korea |
| Dongguk University Ilsan Hospital | Goyang-si | South Korea |
| Chonnam National University Medical School | Gwangju | South Korea |
| Inha University Hospital | Incheon | 22332 | South Korea |
| Ajou University Hospital | Suwon | South Korea |