Long-term Follow-up Study of Livercellgram in Alcoholic LC Patients Who Completed Livercellgram Phase 2 Study
- Conditions
- Alcoholic Liver Cirrhosis
- Registration Number
- NCT02806011
- Lead Sponsor
- 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).
- 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.).
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 48
- 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.
- Not Applicable
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Wonju Severance Christian Hospital
🇰🇷Wŏnju, Korea, Republic of