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Trial record 9 of 14 for:    "Alcoholic Liver Cirrhosis" | "Liver Extracts"

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02806011
Recruitment Status : Enrolling by invitation
First Posted : June 20, 2016
Last Update Posted : November 15, 2018
Sponsor:
Information provided by (Responsible Party):
Pharmicell Co., Ltd.

Tracking Information
First Submitted Date June 15, 2016
First Posted Date June 20, 2016
Last Update Posted Date November 15, 2018
Study Start Date May 2016
Estimated Primary Completion Date December 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: January 22, 2018)
Safety Evaluation assessed by Tumor Marker Test, Adverse Events and Serious Adverse Events, Clinical Laboratory Tests, Vital Signs, and Physical Examinations [ Time Frame: 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
Original Primary Outcome Measures
 (submitted: June 17, 2016)
Safety Evaluation assessed by Tumor Marker Test, Adverse Events and Serious Adverse Events, Clinical Laboratory Tests, Vital Signs, and Physical Examinations [ Time Frame: 3-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
Change History Complete list of historical versions of study NCT02806011 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Long-term Follow-up Study of Livercellgram in Alcoholic LC Patients Who Completed Livercellgram Phase 2 Study
Official Title Long-term Follow-up Study of Livercellgram in Alcoholic Liver Cirrhosis Patients Who Completed Livercellgram Phase 2 Study
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.).

Study Type Observational
Study Design Observational Model: Other
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-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.
Condition Alcoholic Liver Cirrhosis
Intervention Not Provided
Study Groups/Cohorts
  • 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
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Enrolling by invitation
Estimated Enrollment
 (submitted: June 17, 2016)
50
Original Estimated Enrollment Same as current
Estimated Study Completion Date December 2021
Estimated Primary Completion Date December 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria

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
Sex/Gender
Sexes Eligible for Study: All
Ages 20 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Korea, Republic of
Removed Location Countries  
 
Administrative Information
NCT Number NCT02806011
Other Study ID Numbers PMC-P-002-01
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Pharmicell Co., Ltd.
Study Sponsor Pharmicell Co., Ltd.
Collaborators Not Provided
Investigators
Principal Investigator: Soon Koo Baik, M.D.,Ph.D Wonju Severance Christian Hospital
PRS Account Pharmicell Co., Ltd.
Verification Date November 2018