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

Alcoholic Liver Cirrhosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02806011
• Other study ID #: PMC-P-002-01
• Status: Completed
• Start date: May 2016
• Est. completion date: October 2020

Study information

• Verified date: October 2020
• Source: Pharmicell Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

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 information / eligibility

• Status: Completed
• Enrollment: 48
• Est. completion date: October 2020
• Est. primary completion date: October 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Alcoholic Liver Cirrhosis
• Fibrosis
• Liver Cirrhosis
• Liver Cirrhosis, Alcoholic

Locations

Country	Name	City	State
Korea, Republic of	Wonju Severance Christian Hospital	Wonju

Sponsors (1)

Lead Sponsor	Collaborator
Pharmicell Co., Ltd.

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety Evaluation assessed by Tumor Marker Test, Adverse Events and Serious Adverse Events, Clinical Laboratory Tests, Vital Signs, and Physical Examinations	Tumor Marker Test; Occurrence of Adverse Events and Serious Adverse Events; Clinical Laboratory Tests; Vital Sign; Physical Examinations	5-year(+30 days)