An Follow-Up Study of Liver Cirrhosis

An Observational Follow-Up Study of Patients Previously Enrolled in ADR-001-01 Study Against Liver Cirrhosis

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.

Study Overview

• Status: Completed
• Conditions: Decompensated Liver Cirrhosis
• Intervention / Treatment: Drug: Mesenchymal Stem Cell

• Study Type: Observational
• Enrollment (Actual): 19

Contacts and Locations

• Study Contact: Name: Rohto Pharmaceutical Co., Ltd.; Phone Number: +81-3-6823-6014; Email: adr-001@rohto.co.jp

Study Locations

• Japan
  • Niigata, Japan, 951-8510
    • Niigata University Medical & Dental Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Decompensated Liver Cirrhosis

Description

Inclusion Criteria:

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

Exclusion Criteria:

• Patients evaluated by investigators as inappropriate

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change of liver function evaluated by Child-Pugh Score	Change of liver function from the baseline will be evaluated by Child-Pugh score.	Day 0, 28 weeks and 80 weeks (optional 12 weeks and 54 weeks)
Improvement rate of Child-Pugh score	Improvement rate of Child-Pugh score from the baseline will be evaluated.	Day 0, 28 weeks and 80 weeks (optional 12 weeks and 54 weeks)
Improvement rate of Child-Pugh grade	Improvement rate of Child-Pugh grade from the baseline will be evaluated.	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	SBP and DBP will be measured at specific time points (mmHg)	Day 0, 28 weeks and 80 weeks (optional 12 weeks and 54 weeks)
Number of patients with abnormal pulse rate findings	Pulse rate will be measured at specific time points (bit per minutes).	Day 0, 28 weeks and 80 weeks (optional 12 weeks and 54 weeks)
Number of patients with abnormal body temperature findings	Axillary temperature will be measured at specific time points. (degree Celsius)	Day 0, 28 weeks and 80 weeks (optional 12 weeks and 54 weeks)
Number of patients with abnormal electrocardiogram (ECG) findings	12-lead ECG will be obtained at specific time points.	Day 0, 28 weeks and 80 weeks (optional 12 weeks and 54 weeks)
Number of patients with abnormal clinical chemistry parameters	Laboratory assessment for clinical chemistry parameters will include blood total protein, albumin, total and direct bilirubin, aspartate aminotransferase, alanine aminotransferase, r-glutamyltranspeptidase, alkaline phosphatase, cholinesterase, lactate dehydrogenase, uric acid, blood urea nitrogen, ammonia, serum creatinine, sodium, potassium, chlorine, calcium, phosphate, magnesium, C reactive protein creatinine, glucose,	Day 0, 28 weeks and 80 weeks (optional 12 weeks and 54 weeks)
Number of patients with abnormal clinical hematology parameters	Laboratory assessment for clinical hematology will include white blood cell, red blood cell, hemoglobin, hematocrit, platelet, reticulocytes, neutrophils, lymphocytes, eosinophils, basophils, monocytes	Day 0, 28 weeks and 80 weeks (optional 12 weeks and 54 weeks)
Number of patients with abnormal urinalysis parameters	Laboratory assessment for urinalysis will include glucose, protein and occult blood	Day 0, 28 weeks and 80 weeks (optional 12 weeks and 54 weeks)

Collaborators and Investigators

• Sponsor: Rohto Pharmaceutical Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): March 7, 2018
• Primary Completion (Actual): October 12, 2023
• Study Completion (Actual): October 12, 2023

Study Registration Dates

• First Submitted: March 1, 2018
• First Submitted That Met QC Criteria: March 14, 2018
• First Posted (Actual): March 21, 2018

Study Record Updates

• Last Update Posted (Estimated): November 16, 2023
• Last Update Submitted That Met QC Criteria: November 14, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Liver Diseases; Fibrosis; Liver Cirrhosis
• Other Study ID Numbers: ADR-001-02

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No