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

November 22, 2023 updated by: SCM Lifescience Co., LTD.
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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Estimated)

42

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
      • Daegu, Korea, Republic of
        • Kyungpook National University Chilgok Hospital
      • Goyang-si, Korea, Republic of
        • Dongguk University Ilsan Hospital
      • Gwangju, Korea, Republic of
        • Chonnam National University Medical School
      • Incheon, Korea, Republic of, 22332
        • Inha University Hospital
      • Suwon, Korea, Republic of
        • Ajou University Hospital
    • Gyenggi-do
      • Bucheon, Gyenggi-do, Korea, Republic of, 14584
        • Soonchunhyang University Hosptial Bucheon

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

N/A

Sampling Method

Non-Probability Sample

Study Population

Subjects who have received at least 1 dose of SCM-AGH in the SCM-APT2001 study (ClinicalTrials.gov ID: NCT04189419)

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Long-term safety assessment
Time Frame: Up to 5 Years
Ratio and number of cases for subjects who have experienced SAE(Serious Adverse Event).
Up to 5 Years
Mortality
Time Frame: Up to 5 Years
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
Time Frame: Up to 5 Years
The number, ratio, and number of cases of malignant tumor formation
Up to 5 Years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of occurrences of Abnormal, clinically significant in laboratory results
Time Frame: 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
Up to 5 Years
Number of occurrences of Abnormal, clinically significant in Vital Signs
Time Frame: Up to 5 Years
Measure systolic blood pressure, diastolic blood pressure, pulse, and body temperature.
Up to 5 Years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

SCM Lifescience Co., LTD.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 10, 2019

Primary Completion (Estimated)

August 20, 2026

Study Completion (Estimated)

December 31, 2026

Study Registration Dates

First Submitted

June 23, 2023

First Submitted That Met QC Criteria

July 12, 2023

First Posted (Actual)

July 21, 2023

Study Record Updates

Last Update Posted (Actual)

November 28, 2023

Last Update Submitted That Met QC Criteria

November 22, 2023

Last Verified

June 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • APT2001-LTFU

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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