NCT02806011

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
48

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started May 2016

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2016

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

June 15, 2016

Completed
5 days until next milestone

First Posted

Study publicly available on registry

June 20, 2016

Completed
4.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2020

Completed
Last Updated

November 2, 2020

Status Verified

October 1, 2020

Enrollment Period

4.4 years

First QC Date

June 15, 2016

Last Update Submit

October 29, 2020

Conditions

Alcoholic Liver Cirrhosis

Outcome Measures

Primary Outcomes (1)

  • Safety Evaluation assessed by Tumor Marker Test, Adverse Events and Serious Adverse Events, Clinical Laboratory Tests, Vital Signs, and Physical Examinations

    1. Tumor Marker Test 2. Occurrence of Adverse Events and Serious Adverse Events 3. Clinical Laboratory Tests 4. Vital Sign 5. Physical Examinations

    5-year(+30 days)

Study Arms (3)

no Intervention

Long-term follow up of no intervention group

1-time injection group

Long-term follow up of 1-time injection group

2-time injection group

Long-term follow up of 2-time injection group

Eligibility Criteria

Age20 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Subjects who have completed the Livercellgram phase 2 study and can agree to participate in the long term observation study by oneself.

You may qualify if:

  • 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.

You may not qualify if:

  • Not Applicable

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Wonju Severance Christian Hospital

Wŏnju, South Korea

Location

MeSH Terms

Conditions

Liver Cirrhosis, Alcoholic

Condition Hierarchy (Ancestors)

Liver CirrhosisLiver DiseasesDigestive System DiseasesLiver Diseases, AlcoholicFibrosisPathologic ProcessesPathological Conditions, Signs and SymptomsAlcohol-Induced DisordersAlcohol-Related DisordersSubstance-Related DisordersChemically-Induced Disorders

Study Officials

  • Soon Koo Baik, M.D.,Ph.D

    Wonju Severance Christian Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 15, 2016

First Posted

June 20, 2016

Study Start

May 1, 2016

Primary Completion

October 1, 2020

Study Completion

October 1, 2020

Last Updated

November 2, 2020

Record last verified: 2020-10

Locations

KR(1)