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An Follow-Up Study of Liver Cirrhosis

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ClinicalTrials.gov Identifier: NCT03472742
Recruitment Status : Recruiting
First Posted : March 21, 2018
Last Update Posted : November 27, 2018
Sponsor:
Information provided by (Responsible Party):
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.


Condition or disease Intervention/treatment
Decompensated Liver Cirrhosis Drug: Mesenchymal Stem Cell

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Study Type : Observational
Estimated Enrollment : 15 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: An Observational Follow-Up Study of Patients Previously Enrolled in ADR-001-01 Study Against Liver Cirrhosis
Actual Study Start Date : March 7, 2018
Estimated Primary Completion Date : July 31, 2021
Estimated Study Completion Date : July 31, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cirrhosis


Intervention Details:
  • 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.
    Other Name: ADR-001


Primary Outcome Measures :
  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 Outcome Measures :
  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



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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Decompensated Liver Cirrhosis
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03472742


Contacts
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Contact: Rohto Pharmaceutical Co., Ltd. +81-3-6823-6014 adr-001@rohto.co.jp

Locations
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Japan
Niigata University Medical & Dental Hospital Recruiting
Niigata, Japan, 951-8510
Contact: Division of Gastroenterology and Hepatology         
Sponsors and Collaborators
Rohto Pharmaceutical Co., Ltd.

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Responsible Party: Rohto Pharmaceutical Co., Ltd.
ClinicalTrials.gov Identifier: NCT03472742     History of Changes
Other Study ID Numbers: ADR-001-02
First Posted: March 21, 2018    Key Record Dates
Last Update Posted: November 27, 2018
Last Verified: November 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Fibrosis
Liver Cirrhosis
Pathologic Processes
Liver Diseases
Digestive System Diseases