A Phase 1/2 interventional study of Mesenchymal stem cell in Decompensated Liver Cirrhosis, sponsored by Rohto Pharmaceutical Co., Ltd.. Completed at 2 sites in Japan. Open to participants aged 20 Years and older. Per ClinicalTrials.gov, last updated 2023-07-06.
Sponsored by Rohto Pharmaceutical Co., Ltd. · Phase 1/2, Interventional, and Treatment
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 the 14th largest by enrollment of the 19 interventional ones that give a count, is the only one that started in 2017, is one of 2 in phase 1/2, and was the 9th 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. 1 started in 2017.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 21 is below the median of 78 across 741 interventional 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.
This tab as a report to print or save as PDF → With an account.
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 first-in-human Phase1/2 study of ADR-001, adipose-derived mesenchymal stem cells (AD-MSCs). The safety and preliminary efficacy are evaluated in Phase 1 in patients with liver cirrhosis caused by Hepatitis C or Nonalcoholic Steatohepatitis and a recommended Phase 2 dose is determined by the evaluation. The exploratory efficacy and safety are investigated against the same target population in Phase 2.
Patients with decompensated liver cirrhosis (Child-Pugh score; Grade B) caused by Hepatitis C or Nonalcoholic Steatohepatitis are enrolled to the study. In Phase 1, one of 3 doses of AD-MSCs is administered by 1 hour single intravenous infusion. Patients are hospitalized for 1 week and a recommended dose for Phase 2 is determined by the evaluation of the safety and efficacy. In Phase 2, patients with the same disease criteria are enrolled and dosed to investigate the exploratory efficacy and safety.
The safety and efficacy are evaluated until 24 weeks after dosing both in Phase 1 and Phase 2.
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.
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
A score of how well the liver works in people with liver disease such as cirrhosis: class A is mild, B moderate and C severe.
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Hepatitis C tests
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Child-Pugh class
A score of how well the liver works in people with liver disease such as cirrhosis: class A is mild, B moderate and C severe.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECOG performance status
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Phase 1 Dose escalation : low Mid High Single administalation of ADR-001 Phase 2 The recommended dose of ADR-001
Biological: Mesenchymal stem cell
Phase1 The dose of AD-MSCs are escalated from low to mid and high step by step. Each administration is one time via intravenous infusion for one hour. Phase2 The recommended dose of ADR-001 is administrated once a week 4 times. The administration route and time is same method with Phase 1.
Safety profile of ADR-001 including the incidence of adverse events (Phase 1)
Safety will be evaluated based on the medical review of adverse event reports and the results of clinical laboratory tests, vital sign, and physical examinations.
Time frame: 24 weeks
Improvement rate of Child-Pugh score (Phase 2)
Improvement rate of Child-Pugh score from the baseline will be evaluated.
Time frame: 24 weeks
Change of liver function evaluated by Child-Pugh score (Phase 1)
Change of liver function from the baseline will be evaluated by Child-Pugh score.
Time frame: 24 weeks
Improvement rate of Child-Pugh score (Phase 1)
Improvement rate of Child-Pugh score from the baseline will be evaluated.
Time frame: 24 weeks
Improvement rate of Child-Pugh grade (Phase 1)
Improvement rate of Child-Pugh grade from the baseline will be evaluated.
Time frame: 24 weeks
Change of liver function evaluated by Child-Pugh score (Phase 2)
Change of liver function from the baseline will be evaluated by Child-Pugh score.
Time frame: 24 weeks
Improvement rate of Child-Pugh grade (Phase 2)
Improvement rate of Child-Pugh grade from the baseline will be evaluated.
Time frame: 24 weeks
Safety profile of ADR-001 including the incidence of adverse events (Phase 2)
Safety will be evaluated based on the medical review of adverse event reports and the results of clinical laboratory tests, vital sign, and physical examinations.
Time frame: 24 weeks
Ran from Jul 2017 to primary completion in Apr 2023, 68 months.
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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Studies of the drug tested here: Mesenchymal Stem Cell
Rohto Pharmaceutical Co., Ltd.