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NCT Number: NCT03472742

An Follow-Up Study of 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.

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Key information

Conditions

Decompensated Liver Cirrhosis

Age range

20 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Niigata University Medical & Dental Hospital

Niigata, 951-8510, Japan

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Other names: ADR-001

Primary outcomes

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

    Time frame: 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 outcomes

  1. Change of liver function evaluated by Child-Pugh Score

    Time frame: 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.

  2. Improvement rate of Child-Pugh score

    Time frame: 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.

  3. Improvement rate of Child-Pugh grade

    Time frame: 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.

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

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

    SBP and DBP will be measured at specific time points (mmHg)

  5. Number of patients with abnormal pulse rate findings

    Time frame: 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).

  6. Number of patients with abnormal body temperature findings

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

    Axillary temperature will be measured at specific time points. (degree Celsius)

  7. Number of patients with abnormal electrocardiogram (ECG) findings

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

    12-lead ECG will be obtained at specific time points.

  8. Number of patients with abnormal clinical chemistry parameters

    Time frame: 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,

  9. Number of patients with abnormal clinical hematology parameters

    Time frame: 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

  10. Number of patients with abnormal urinalysis parameters

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

    Laboratory assessment for urinalysis will include glucose, protein and occult blood

Sponsors and collaborators

Lead sponsor

Rohto Pharmaceutical Co., Ltd.

Industry

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2023
Study completion
2023
First posted
Mar 21, 2018
Registry last updated
Nov 18, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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