NCT02806011

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

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 48 (actual)
• Sponsor: Pharmicell Co., Ltd. · Industry
• Sex: All
• Age: 20 Years – 70 Years
• Healthy volunteers: Not accepted

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.).

Conditions

• Alcoholic Liver Cirrhosis

Timeline

• Start date: 2016-05-01
• Primary completion: 2020-10-01
• Completion: 2020-10-01
• First posted: 2016-06-20
• Last updated: 2020-11-02

Locations

1 site across 1 country: South Korea