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) ]
- Tumor Marker Test
- Occurrence of Adverse Events and Serious Adverse Events
- Clinical Laboratory Tests
- Vital Sign
- 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