Long-term Follow-up Study of Livercellgram in Alcoholic LC Patients Who Completed Livercellgram Phase 2 Study

October 29, 2020 updated by: Pharmicell Co., Ltd.

Long-term Follow-up Study of Livercellgram in Alcoholic Liver Cirrhosis Patients Who Completed Livercellgram Phase 2 Study

This is a 5-year (+30 days) long term follow up study to evaluate the safety of Livercellgram in subject who participated in and completed the Livercellgram Phase 2 trials (refer to ClinicalTrials.gov.Identifier: NCT01875081).

Study Overview

Status

Completed

Detailed Description

This is a 5-year (+30 days) long term follow up study to evaluate the safety of Livercellgram in subject who participated in and completed the Livercellgram Phase 2 trials (refer to ClinicalTrials.gov.Identifier: NCT01875081).

This trial is planned to evaluate the safety of Livercellgram in patients with alcoholic liver cirrhosis. Subjects who signed this follow-up observation informed consent form will participate in a safety assessment (tumor marker test, occurrence of adverse events and serious adverse events, clinical laboratory tests, vital sign, physical examinations.).

Study Type

Observational

Enrollment (Actual)

48

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

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

20 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Subjects who have completed the Livercellgram phase 2 study and can agree to participate in the long term observation study by oneself.

Description

Inclusion Criteria:

  1. Subjects who treated with Livercellgram and completed the Livercellgram phase 2 study.
  2. Subjects who can agree to participate in the long term observation study by oneself.

Exclusion Criteria:

  • Not Applicable

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

  • Observational Models: Other
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
no Intervention
Long-term follow up of no intervention group
1-time injection group
Long-term follow up of 1-time injection group
2-time injection group
Long-term follow up of 2-time injection group

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Safety Evaluation assessed by Tumor Marker Test, Adverse Events and Serious Adverse Events, Clinical Laboratory Tests, Vital Signs, and Physical Examinations
Time Frame: 5-year(+30 days)
  1. Tumor Marker Test
  2. Occurrence of Adverse Events and Serious Adverse Events
  3. Clinical Laboratory Tests
  4. Vital Sign
  5. Physical Examinations
5-year(+30 days)

Collaborators and Investigators

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

Investigators

  • Principal Investigator: Soon Koo Baik, M.D.,Ph.D, Wonju Severance Christian Hospital

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

May 1, 2016

Primary Completion (Actual)

October 1, 2020

Study Completion (Actual)

October 1, 2020

Study Registration Dates

First Submitted

June 15, 2016

First Submitted That Met QC Criteria

June 17, 2016

First Posted (Estimate)

June 20, 2016

Study Record Updates

Last Update Posted (Actual)

November 2, 2020

Last Update Submitted That Met QC Criteria

October 29, 2020

Last Verified

October 1, 2020

More Information

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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