An Follow-Up Study of Liver Cirrhosis

NCT03472742 | Completed

• 1 other identifier: ADR-001-02
• Study Type: observational
• Target: 19
• Locations: 1 country
• Sites: 1

Brief Summary

This is a follow-up study to assess safety and preliminary clinical activity of ADR-001 in patients with liver cirrhosis (Child-Pugh score; Grade B) caused by Hepatitis C or Nonalcoholic Steatohepatitis. Patients who have already participated in the ADR-001-01 study and completed the last evaluation after 24 weeks of administration will be eligible to this study. Patients registered will continue follow-up observation and evaluate long-term safety and exploratory efficacy.

Conditions

Decompensated Liver Cirrhosis

Outcome Measures

Primary Outcomes (1)

• Number of patients with adverse events (AEs) and serious AEs (SAEs)

  An AE is any untoward medical event for the patient in the clinical study, associated with study medication. Any untoward event resulting in death, life threatening, requires hospitalization or prolongation of hospitalization, results in disability/incapacity, congenital anomaly/birth defect will be evaluated as an SAE.

  Change from Baseline (Day 0) until 80 weeks

Secondary Outcomes (10)

• Change of liver function evaluated by Child-Pugh Score

  Day 0, 28 weeks and 80 weeks (optional 12 weeks and 54 weeks)

• Improvement rate of Child-Pugh score

  Day 0, 28 weeks and 80 weeks (optional 12 weeks and 54 weeks)

• Improvement rate of Child-Pugh grade

  Day 0, 28 weeks and 80 weeks (optional 12 weeks and 54 weeks)

• Number of patients with abnormal systolic blood pressure (SBP) and diastolic blood pressure (DBP) findings

  Day 0, 28 weeks and 80 weeks (optional 12 weeks and 54 weeks)

• Number of patients with abnormal pulse rate findings

  Day 0, 28 weeks and 80 weeks (optional 12 weeks and 54 weeks)

Interventions

Mesenchymal Stem Cell DRUG

As this is a follow-up and an observation study, ADR-001 was administered in the previous study, not in this study.

Also known as: ADR-001

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Decompensated Liver Cirrhosis

You may qualify if:

• Liver cirrhosis patients enrolled in ADR-001-01 study and completed the last observation of the study
• Voluntary signed informed consent

You may not qualify if:

• Patients evaluated by investigators as inappropriate

Sponsors & Collaborators

• Rohto Pharmaceutical Co., Ltd.: lead

Study Sites (1)

Niigata University Medical & Dental Hospital

Niigata, 951-8510, Japan

Location

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 1, 2018
• First Posted: March 21, 2018
• Study Start: March 7, 2018
• Primary Completion: October 12, 2023
• Study Completion: October 12, 2023
• Last Updated: November 18, 2023

Record last verified: 2023-07

Locations

JP (1)