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Active, Not Recruiting

NCT Number: NCT05955235

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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Pancreatitis, Acute Digestive System Diseases Pancreatic Diseases Pancreatitis

Age range

19 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Soonchunhyang University Hosptial Bucheon, Bucheon-si, Gyenggi-do, South Korea

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About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Not Applicable(Observation Study)

Other

Not Applicable(Observation Study)

Primary outcomes

  1. Long-term safety assessment

    Time frame: Up to 5 Years

    Ratio and number of cases for subjects who have experienced SAE(Serious Adverse Event).

  2. Mortality

    Time frame: Up to 5 Years

    Ratio of subjects who died during long-term safety follow-up

  3. 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

Secondary outcomes

  1. 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

  2. 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.

Sponsors and collaborators

Lead sponsor

SCM Lifescience Co., LTD.

Industry

Registry information

Important dates

Study start
2019
Primary completion
2026
Study completion
2026
First posted
Jul 21, 2023
Registry last updated
Nov 28, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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