Decompensated Liver Cirrhosis
Conditions
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.
Interventions
DRUGMesenchymal Stem Cell
As this is a follow-up and an observation study, ADR-001 was administered in the previous study, not in this study.
Sponsors
Rohto Pharmaceutical Co., Ltd.
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of patients with adverse events (AEs) and serious AEs (SAEs) | Change from Baseline (Day 0) until 80 weeks | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Improvement rate of Child-Pugh score | Day 0, 28 weeks and 80 weeks (optional 12 weeks and 54 weeks) | Improvement rate of Child-Pugh score from the baseline will be evaluated. |
| Improvement rate of Child-Pugh grade | Day 0, 28 weeks and 80 weeks (optional 12 weeks and 54 weeks) | Improvement rate of Child-Pugh grade from the baseline will be evaluated. |
| 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) | SBP and DBP will be measured at specific time points (mmHg) |
| Number of patients with abnormal pulse rate findings | Day 0, 28 weeks and 80 weeks (optional 12 weeks and 54 weeks) | Pulse rate will be measured at specific time points (bit per minutes). |
| Change of liver function evaluated by Child-Pugh Score | Day 0, 28 weeks and 80 weeks (optional 12 weeks and 54 weeks) | Change of liver function from the baseline will be evaluated by Child-Pugh score. |
| Number of patients with abnormal electrocardiogram (ECG) findings | Day 0, 28 weeks and 80 weeks (optional 12 weeks and 54 weeks) | 12-lead ECG will be obtained at specific time points. |
| Number of patients with abnormal clinical chemistry parameters | Day 0, 28 weeks and 80 weeks (optional 12 weeks and 54 weeks) | 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, |
| Number of patients with abnormal clinical hematology parameters | Day 0, 28 weeks and 80 weeks (optional 12 weeks and 54 weeks) | Laboratory assessment for clinical hematology will include white blood cell, red blood cell, hemoglobin, hematocrit, platelet, reticulocytes, neutrophils, lymphocytes, eosinophils, basophils, monocytes |
| Number of patients with abnormal urinalysis parameters | Day 0, 28 weeks and 80 weeks (optional 12 weeks and 54 weeks) | Laboratory assessment for urinalysis will include glucose, protein and occult blood |
| Number of patients with abnormal body temperature findings | Day 0, 28 weeks and 80 weeks (optional 12 weeks and 54 weeks) | Axillary temperature will be measured at specific time points. (degree Celsius) |
Countries
Japan
Outcome results
None listed