An Follow-Up Study of Liver Cirrhosis

Completed

• Conditions: Decompensated Liver Cirrhosis

• Registration Number: NCT03472742
• Lead Sponsor: Rohto Pharmaceutical Co., Ltd.

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-03-01
• Study Start: 2018-03-07
• Study First Submitted QC: 2018-03-14
• Study First Posted: 2018-03-21
• Status Verified: 2023-07
• Primary Completion: 2023-10-12
• Study Completion: 2023-10-12
• Last Update Submitted: 2023-11-14
• Last Update Posted: 2023-11-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 19

Inclusion Criteria

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

Read More

Exclusion Criteria

• Patients evaluated by investigators as inappropriate

Read More

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.
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)
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.
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 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 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).
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)
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

Trial Locations

Locations (1)

Niigata University Medical & Dental Hospital; 🇯🇵 Niigata, Japan