An observational study in Decompensated Liver Cirrhosis, sponsored by Rohto Pharmaceutical Co., Ltd.. Completed at 1 site in Japan. Open to participants aged 20 Years and older. Per ClinicalTrials.gov, last updated 2023-11-18.
Sponsored by Rohto Pharmaceutical Co., Ltd. · Observational
Among 26 studies in Liver Cirrhosis with a site in Japan — 3 open to participants now, 3 under way, 1 of them phase 3. Liver Cirrhosis · Japan.
Among the 26 studies in Liver Cirrhosis with a site in Japan, this one is one of 5 that started in 2018, is one of 7 observational ones, and was the 10th registered.
1,300 studies on the registry are indexed under Liver Cirrhosis; 341 are open to participants now.
Browse Liver Cirrhosis studies →3 of the 26 studies in Liver Cirrhosis with a site in Japan are open now. Recruiting first, the newest first:
Kiminori Kimura, MD · Sites in Japan
Ages 18–79 · Men only
Boehringer Ingelheim · Sites in Japan, United States, Argentina and 34 more countries
Ages 18+
European Foundation for Study of Chronic Liver Failure · Sites in Japan, United States, Argentina and 24 more countries
Ages 18–80
A study can be open while its sites in Japan have not opened yet or have stopped. Only those recruiting at a site in Japan →
Of the 209 Liver Cirrhosis studies recruiting now, 101 (48%) set no upper age limit and 67 (32%) stop at 75 or younger; 12 take children under 18; 25 take healthy volunteers.
This study: 20 Years and older · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
26 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 5 · Phase 2 11 · Phase 3 3
First in 2003; this study’s year is marked. 5 started in 2018.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 19 is below the median of 171 across 526 observational studies indexed under Liver Cirrhosis.
Median enrollment 56 across the 19 interventional studies, 500 across the 7 observational. Of the 18 that completed or were terminated, 7 (39%) have results posted.
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12 of 26 have an industry lead sponsor. The 10 most frequent:
Rohto Pharmaceutical Co., Ltd. is the lead sponsor of 6 studies on the registry; 1 is open to participants now.
Rohto Pharmaceutical Co., Ltd. has 2 studies filed under Liver Cirrhosis — fewer than ten, so there is no comparison to draw.
2 of the studies in Liver Cirrhosis with a site in Japan that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT04613921European Foundation for Study of Chronic Liver FailureLiver Transplantation in Patients With CirrHosis and Severe Acute-on-Chronic Liver Failure: iNdications and outComEs | 2026-12-31 |
| NCT07681089Kiminori Kimura, MDA Phase 2 Study of Foscenvivint in Liver Cirrhosis Patients Caused by HIV/HCV Co-infection With Hemophilia | 2027-11-30 |
Add all 2 to your calendar (.ics) → With an account.
Among the 26 studies in Liver Cirrhosis with a site in Japan, from their registry updates:
This tab as a report to print or save as PDF → With an account.
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.
Decompensated Liver Cirrhosis
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
As this is a follow-up and an observation study, ADR-001 was administered in the previous study, not in this study.
Also known as: ADR-001
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.
Time frame: Change from Baseline (Day 0) until 80 weeks
Change of liver function evaluated by Child-Pugh Score
Change of liver function from the baseline will be 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
Improvement rate of Child-Pugh score from the baseline will be evaluated.
Time frame: 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.
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
SBP and DBP will be measured at specific time points (mmHg)
Time frame: 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).
Time frame: 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)
Time frame: 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.
Time frame: 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,
Time frame: 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
Time frame: 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
Time frame: Day 0, 28 weeks and 80 weeks (optional 12 weeks and 54 weeks)
Ran from Mar 2018 to primary completion in Oct 2023, 67 months.
Of 247 observational studies under Liver Cirrhosis, half reached primary completion within 47 months of starting (the median), counting those still running; a quarter within 18 and three quarters within 71. This study's 67 months is above that.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Jul 2023. You cannot join it, but the record below documents what was studied.
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Rohto Pharmaceutical Co., Ltd.