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

NCT ID: NCT05955235

Last Updated: 2023-11-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Total Enrollment

42 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-05-10

Study Completion Date

2026-12-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Pancreatitis, Acute

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Interventions

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Not Applicable(Observation Study)

Not Applicable(Observation Study)

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

19 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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SCM Lifescience Co., LTD.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Soonchunhyang University Hosptial Bucheon

Bucheon-si, Gyenggi-do, South Korea

Site Status

Kyungpook National University Chilgok Hospital

Daegu, , South Korea

Site Status

Dongguk University Ilsan Hospital

Goyang-si, , South Korea

Site Status

Chonnam National University Medical School

Gwangju, , South Korea

Site Status

Inha University Hospital

Incheon, , South Korea

Site Status

Ajou University Hospital

Suwon, , South Korea

Site Status

Countries

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South Korea

Other Identifiers

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APT2001-LTFU

Identifier Type: -

Identifier Source: org_study_id