Decompensated Liver CirrhosisNCT03472742
An Follow-Up Study of Liver Cirrhosis
An observational study of Decompensated Liver Cirrhosis, run by Rohto Pharmaceutical Co., Ltd. at 1 site in Japan.
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. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Decompensated Liver Cirrhosis
- What is being tested?
- Mesenchymal Stem Cell
- How many people
- 19 participants
- Where
- 1 siteJapan
- Study dates
- 7 Mar 2018to 12 Oct 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Decompensated Liver Cirrhosis
Who may be able to join
- Liver cirrhosis patients enrolled in ADR-001-01 study and completed the last observation of the study
- Voluntary signed informed consent
Who cannot join
- Patients evaluated by investigators as inappropriate
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Observational Follow-Up Study of Patients Previously Enrolled in ADR-001-01 Study Against 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.
- Conditions
- Decompensated Liver Cirrhosis
- Being tested
- Mesenchymal Stem Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mesenchymal Stem CellDrug
Also called ADR-001
As this is a follow-up and an observation study, ADR-001 was administered in the previous study, not in this study.
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Change from Baseline (Day 0) until 80 weeks
Secondary outcomes (10)
Change of liver function evaluated by Child-Pugh Score
Change of liver function from the baseline will be evaluated by Child-Pugh score.
Measured: Day 0, 28 weeks and 80 weeks (optional 12 weeks and 54 weeks)
Improvement rate of Child-Pugh score
Improvement rate of Child-Pugh score from the baseline will be evaluated.
Measured: Day 0, 28 weeks and 80 weeks (optional 12 weeks and 54 weeks)
Improvement rate of Child-Pugh grade
Improvement rate of Child-Pugh grade from the baseline will be evaluated.
Measured: Day 0, 28 weeks and 80 weeks (optional 12 weeks and 54 weeks)
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)
Measured: Day 0, 28 weeks and 80 weeks (optional 12 weeks and 54 weeks)
Number of patients with abnormal pulse rate findings
Pulse rate will be measured at specific time points (bit per minutes).
Measured: Day 0, 28 weeks and 80 weeks (optional 12 weeks and 54 weeks)
Number of patients with abnormal body temperature findings
Axillary temperature will be measured at specific time points. (degree Celsius)
Measured: Day 0, 28 weeks and 80 weeks (optional 12 weeks and 54 weeks)
Number of patients with abnormal electrocardiogram (ECG) findings
12-lead ECG will be obtained at specific time points.
Measured: Day 0, 28 weeks and 80 weeks (optional 12 weeks and 54 weeks)
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,
Measured: Day 0, 28 weeks and 80 weeks (optional 12 weeks and 54 weeks)
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
Measured: Day 0, 28 weeks and 80 weeks (optional 12 weeks and 54 weeks)
Number of patients with abnormal urinalysis parameters
Laboratory assessment for urinalysis will include glucose, protein and occult blood
Measured: Day 0, 28 weeks and 80 weeks (optional 12 weeks and 54 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2018
- Study start7 Mar 2018
- Primary completion12 Oct 2023
- Study completion12 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Decompensated Liver CirrhosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rohto Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03472742
- Sponsor's protocol ID
- ADR-001-02
- Status last verified
- Jul 2023
- First submitted
- 1 Mar 2018
- Last updated
- 18 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Observational Follow-Up Study of Patients Previously Enrolled in ADR-001-01 Study Against Liver Cirrhosis
- ClinicalTrials.gov ID
- NCT03472742
- Acronym / sponsor ID
- ADR-001-02
- Conditions
- Decompensated Liver Cirrhosis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- Rohto Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 7 Mar 2018 (actual)
- Primary completion
- 12 Oct 2023 (actual)
- Study completion
- 12 Oct 2023 (actual)
- First posted
- 21 Mar 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Decompensated Liver Cirrhosis
Key inclusion criteria (2 listed)
- Liver cirrhosis patients enrolled in ADR-001-01 study and completed the last observation of the study
- Voluntary signed informed consent
Key exclusion criteria (1 listed)
- Patients evaluated by investigators as inappropriate
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mesenchymal Stem CellAlso: ADR-001As this is a follow-up and an observation study, ADR-001 was administered in the previous study, not in this study. | Drug | – |
Primary outcome
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.
10 secondary outcomes
Change of liver function evaluated by Child-Pugh Score
Time frame: Day 0, 28 weeks and 80 weeks (optional 12 weeks and 54 weeks)
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 grade
Time frame: Day 0, 28 weeks and 80 weeks (optional 12 weeks and 54 weeks)
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)
Number of patients with abnormal pulse rate findings
Time frame: Day 0, 28 weeks and 80 weeks (optional 12 weeks and 54 weeks)
Number of patients with abnormal body temperature findings
Time frame: Day 0, 28 weeks and 80 weeks (optional 12 weeks and 54 weeks)
Number of patients with abnormal electrocardiogram (ECG) findings
Time frame: Day 0, 28 weeks and 80 weeks (optional 12 weeks and 54 weeks)
Number of patients with abnormal clinical chemistry parameters
Time frame: Day 0, 28 weeks and 80 weeks (optional 12 weeks and 54 weeks)
Number of patients with abnormal clinical hematology parameters
Time frame: Day 0, 28 weeks and 80 weeks (optional 12 weeks and 54 weeks)
Number of patients with abnormal urinalysis parameters
Time frame: Day 0, 28 weeks and 80 weeks (optional 12 weeks and 54 weeks)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Decompensated Liver Cirrhosis, run by Rohto Pharmaceutical Co., Ltd. at 1 site in Japan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of patients with adverse events (AEs) and serious AEs (SAEs) (time frame: Change from Baseline (Day 0) until 80 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Nov 2023.