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

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ClinicalTrials.gov Identifier: NCT02806011
Recruitment Status : Enrolling by invitation
First Posted : June 20, 2016
Last Update Posted : November 15, 2018
Sponsor:
Information provided by (Responsible Party):
Pharmicell Co., Ltd.

Brief Summary:
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).

Condition or disease
Alcoholic Liver Cirrhosis

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.).


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Study Type : Observational
Estimated Enrollment : 50 participants
Observational Model: Other
Time Perspective: Prospective
Official Title: Long-term Follow-up Study of Livercellgram in Alcoholic Liver Cirrhosis Patients Who Completed Livercellgram Phase 2 Study
Study Start Date : May 2016
Estimated Primary Completion Date : December 2021
Estimated Study Completion Date : December 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cirrhosis

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



Primary Outcome Measures :
  1. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02806011


Locations
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Korea, Republic of
Wonju Severance Christian Hospital
Wŏnju, Korea, Republic of
Sponsors and Collaborators
Pharmicell Co., Ltd.
Investigators
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Principal Investigator: Soon Koo Baik, M.D.,Ph.D Wonju Severance Christian Hospital

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Responsible Party: Pharmicell Co., Ltd.
ClinicalTrials.gov Identifier: NCT02806011     History of Changes
Other Study ID Numbers: PMC-P-002-01
First Posted: June 20, 2016    Key Record Dates
Last Update Posted: November 15, 2018
Last Verified: November 2018

Additional relevant MeSH terms:
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Liver Cirrhosis
Liver Cirrhosis, Alcoholic
Fibrosis
Pathologic Processes
Liver Diseases
Digestive System Diseases
Liver Diseases, Alcoholic
Alcohol-Induced Disorders
Alcohol-Related Disorders
Substance-Related Disorders
Chemically-Induced Disorders