An Follow-Up Study of Liver Cirrhosis

Decompensated Liver Cirrhosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03472742
• Other study ID #: ADR-001-02
• Status: Completed
• Start date: March 7, 2018
• Est. completion date: October 12, 2023

Study information

• Verified date: July 2023
• Source: Rohto Pharmaceutical Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 19
• Est. completion date: October 12, 2023
• Est. primary completion date: October 12, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Decompensated Liver Cirrhosis
• Fibrosis
• Liver Cirrhosis

Intervention

Drug:
• Mesenchymal Stem Cell
As this is a follow-up and an observation study, ADR-001 was administered in the previous study, not in this study.

Locations

Country	Name	City	State
Japan	Niigata University Medical & Dental Hospital	Niigata

Sponsors (1)

Lead Sponsor	Collaborator
Rohto Pharmaceutical Co., Ltd.

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)