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NCT Number: NCT02806011

Long-term Follow-up Study of Livercellgram in Alcoholic LC 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).

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Key information

Conditions

Alcoholic Liver Cirrhosis Alcohol-Induced Disorders Alcohol-Related Disorders Chemically-Induced Disorders Digestive System Diseases Fibrosis Liver Cirrhosis Liver Cirrhosis, Alcoholic Liver Diseases Liver Diseases, Alcoholic Pathologic Processes Pathological Conditions, Signs and Symptoms Substance-Related Disorders

Age range

20 year–70 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Wonju Severance Christian Hospital

Wŏnju, South Korea

About this 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).

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.).

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

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

Exclusion criteria

  • Not Applicable

Treatment and study plan

Primary outcomes

  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)

    • Tumor Marker Test
    • Occurrence of Adverse Events and Serious Adverse Events
    • Clinical Laboratory Tests
    • Vital Sign
    • Physical Examinations

Sponsors and collaborators

Lead sponsor

Pharmicell Co., Ltd.

Industry

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2020
Study completion
2020
First posted
Jun 20, 2016
Registry last updated
Nov 2, 2020

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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