Alcoholic Liver Cirrhosis
Conditions
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).
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.).
Interventions
None listed
Sponsors
Pharmicell Co., Ltd.
Study design
Observational model
OTHER
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
20 Years to 70 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Safety Evaluation assessed by Tumor Marker Test, Adverse Events and Serious Adverse Events, Clinical Laboratory Tests, Vital Signs, and Physical Examinations | 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 |
Countries
South Korea
Outcome results
None listed