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New treatment option for Decompensated Cirrhosis
Official title CirrhoCare- Using Smart-phone Technology to Enhance Care and Access to Treatment for Cirrhosis
ClinicalTrials.gov ID: NCT06223893
What this study is testing
- What it's testing
- The CirrhoCare trial is a multi-centre, open label randomised controlled trial in patients with decompensated cirrhosis. The trial aims to investigate the clinical and cost-effectiveness of CirrhoCare digital home monitoring and management with current standard of care in these patients.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Adults ≥ 18 years and diagnosed with cirrhosis of any aetiology.
- Cirrhosis defined by standard clinical criteria, ultrasonographic findings and/or histology. Cirrhosis of any aetiology may be included. However...
- Cirrhosis severity-risk defined by European-Foundation Consortium Liver Failure - Acute Decompensation score (CLIF-C AD score) ≥42 points but ≤65...
- Hospitalisation for acute decompensation [determined as one or more of the following: increasing ascites, variceal haemorrhage, overt hepatic...
- Participants able to give informed consent.
You likely can't join if
- Participants with ACLF grade 2 and above according to the criteria published by Moreau
- Participants with CLIF-C AD score ≥ 66, who have a high mortality similar to ACLF ≥2 participants.
- Current overt hepatic encephalopathy, defined as grade II-IV hepatic encephalopathy according to the West-Haven classification, unable to give...
- Participants with active hepatocellular carcinoma (HCC) or history of HCC that is in remission for less than six months for uninodular HCC or for...
- Participants with a history of significant extra hepatic disease with impaired short-term prognosis, including congestive heart failure New York...
- Participants with documented refractory ascites on a palliative pathway.
See the full eligibility criteria
- Adults ≥ 18 years and diagnosed with cirrhosis of any aetiology.
- Cirrhosis defined by standard clinical criteria, ultrasonographic findings and/or histology. Cirrhosis of any aetiology may be included. However, participants with cirrhosis due to autoimmune hepatitis must be on a...
- Cirrhosis severity-risk defined by European-Foundation Consortium Liver Failure - Acute Decompensation score (CLIF-C AD score) ≥42 points but ≤65 points at the time of screening.
- Hospitalisation for acute decompensation [determined as one or more of the following: increasing ascites, variceal haemorrhage, overt hepatic encephalopathy, spontaneous bacterial peritonitis (SBP) or hepatorenal...
- Participants able to give informed consent.
- Participants with ACLF grade 2 and above according to the criteria published by Moreau
- Participants with CLIF-C AD score ≥ 66, who have a high mortality similar to ACLF ≥2 participants.
- Current overt hepatic encephalopathy, defined as grade II-IV hepatic encephalopathy according to the West-Haven classification, unable to give consent.
- Participants with active hepatocellular carcinoma (HCC) or history of HCC that is in remission for less than six months for uninodular HCC or for less than 12 months for multinodular HCC within Milan criteria.
- Participants with a history of significant extra hepatic disease with impaired short-term prognosis, including congestive heart failure New York Heart Association Grade III/IV, COPD GOLD \>2, chronic kidney disease with...
- Participants with documented refractory ascites on a palliative pathway.
- Participants who are active on the transplant waiting list.
- Participants with current extra hepatic malignancies including solid tumours and hematologic disorders.
- Participants with mental incapacity, significant language barriers, or any other reason considered by the investigator precluding adequate understanding, cooperation or compliance in the study.
- Participants with active viral infections, or yet to achieve clear response to anti-viral therapy.
- Any disorders likely to impact on study engagement, including severe frailty, severe addiction history (including opioids) with evidence of multiple recent relapses.
- Any other reason that the PI considers would make the participant unsuitable to enter CirrhoCare (e.g., participants on an end-of-life palliative care pathway).
- Participants enrolled in other treatment trials.
The study team makes the final eligibility decision.
Where it's taking place
- Birmingham, United Kingdom
- Brighton, United Kingdom
- Coventry, United Kingdom
- Liverpool, United Kingdom
- London, United Kingdom
- Nottingham, United Kingdom
- Oxford, United Kingdom
- Plymouth, United Kingdom
- Southampton, United Kingdom
- Torquay, United Kingdom
Compensation & support
A stipend or compensation may be offered.
Compensation likely.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Birmingham, United Kingdom; Brighton, United Kingdom; Coventry, United Kingdom; Liverpool, United Kingdom; London, United Kingdom; Nottingham, United Kingdom and 4 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.