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

Study Status: Enrolling by invitation
Recruit Status: Enrolling by invitation
Study Type: Interventional

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

Brief Summary:

This is a 3-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.).


Detailed Summary:
Sponsor: Pharmicell Co., Ltd.

Current Primary Outcome: Safety Evaluation assessed by Tumor Marker Test, Adverse Events and Serious Adverse Events, Clinical Laboratory Tests, Vital Signs, and Physical Examinations [ Time Frame: 3-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


Original Primary Outcome: Same as current

Current Secondary Outcome:

Original Secondary Outcome:

Information By: Pharmicell Co., Ltd.

Dates:
Date Received: June 15, 2016
Date Started: May 2016
Date Completion: January 2018
Last Updated: June 21, 2016
Last Verified: January 2016