Decompensated CirrhosisSUPERMELDNCT03820271
New Prognostic Predictive Models of Mortality of Decompensated Cirrhotic Patients Waiting for Liver Transplantation
A study testing SuperMELD in people with Decompensated Cirrhosis and Liver Transplantation, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
The MELD score is a predictive model of cirrhosis mortality used in France since 2007 to prioritize access to liver transplantation for patients enrolled in the national waiting list. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Decompensated Cirrhosis, Liver Transplantation
- What is being tested?
- SuperMELD
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 501 participants
- Where
- 1 siteFrance
- Study dates
- 2 Oct 2020to 11 Nov 2025
- Phase
- Interventional
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult patients (≥18 years old) registered on national waiting list with main diagnosis "cirrhosis" within 14 days (+/-2) before or 7 days (+/-2) after the inclusion in the protocol (using the date of biobank sampling as Day 0)
- Patients enrolled on the national waiting list under the "national liver score" allocation scheme whether an expert component is considered or not
- Patients (or trusted person or family member or close relation if the patient is unable to express consent) who have been informed and signed their informed consent
- Patients affiliated to a health insurance scheme
Who cannot join
- Patients enrolled with decompensated cirrhosis associated with hepatocellular carcinoma >TNM1
- Patients on AVK (INR and therefore MELD and CLIF scores uninterpretable)
- Vulnerable population (person under guardianship or curatorship or deprived of liberty by a judicial decision)
- Pregnant and / or breastfeeding woman
- Patient candidate for a combined transplantation
- Patient with history of organ transplantation (liver, kidney, heart)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Construction of New Predictive Mathematical Models of Mortality in Decompensated Cirrhotic Patients Who Are Candidates for Liver Transplantation
The MELD score is a predictive model of cirrhosis mortality used in France since 2007 to prioritize access to liver transplantation for patients enrolled in the national waiting list. The predictive value of this score was recently revised downward with a C index of the order of 0.65-0.67 and 20% of the patients enrolled for decompensated cirrhosis have access to liver transplantation by a subjective system of "expert component" independent of the MELD because of this lack of precision. The use of the MELD score to individually define access to the transplant should so be reconsidered. Recently new predictive models of cirrhosis mortality better than MELD have been developed and new mortality predictors independent of MELD have been published.
The goal of this study is to design prognostic predictive models of mortality for decompensated cirrhotic patients enrolled on the national liver transplant waiting list including known (MELD, MELD Na) as more recent (CLIF-C AD, CLIF - CACLF) predictive models and new objective predictors studied in combination in order to optimize the system of allocation of hepatic allografts in France.
Read more
The expected benefits of this search are twofold:
- At the individual level: The possibility for patients at high risk of death but with intermediate MELD score to be transplanted.
- Public health plan:
- Improving the equity of graft allocation system.
- Decreased mortality in the waiting list by improving the fairness and efficiency of the graft allocation system, a major public health issue
- An ancillary study to the SUPERMELD study is also proposed, the miR MELD study, whose main objective is to evaluate the value of plasma miRNAs in a cohort of patients with decompensated cirrhosis (acute and chronic, excluding cancer) listed for liver transplantation to predict 3-month mortality on the liver transplant waiting list or drop-out from the waitlist for being too sick.
Additional data collection of the vital status 1 year after transplantation of patients initially included in the SUPERMELD study will also be added for all transplanted patients to assess the potential acceleration of access to transplantation for certain candidates at high risk of death prior to transplantation on post-transplantation survival, and assess the transplant benefit.
- Conditions
- Decompensated Cirrhosis, Liver Transplantation
- Being tested
- SuperMELD
- Keywords
- Liver transplantation, Predictive prognostic models, Decompensated cirrhosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SuperMELDOther
The population of this arm will consist of patients newly enrolled in the National Liver Transplantation Waiting List for decompensated cirrhosis, whose liver function and MELD score are assessed at enrollment and then routinely reassessed at least quarterly during the waiting phase.
Patients will be followed from their listing to transplantation or discharge or death.
| Study group | Role | What they receive |
|---|---|---|
| SuperMELD | Other | Not described Receives: Other: SuperMELD |
What is being measured
The primary outcome is the main question the study is designed to answer.
predictive value of the new multivariate prognostic models in patients listed for decompensated cirrhosis
Predictive value of mortality and drop out in the waiting list
Measured: Month 3.
Secondary outcomes (4)
Individual predictive value of each of the new candidate predictors
CRP, copeptin, NT-pro BNP, vitamin D, leucocytes, PMN/lymphocytes ratio, urinary NGal, cystatin C, frailty index, sarcopenia (abdominal tomodensitometry to measure the surface of psoas), caloric intake, encephalopathy (ammonia level, stroop application), and transferrin.
Measured: Month 3. Month 6, Month 9, Month 12Month 12
Complications predicted by each of the independent predictors
infection, renal dysfunction, encephalopathy, bleeding, ACLF
Measured: Month 3 Month 6, Month 9, Month 12.Month 12
Added predictive value for mortality and drop out of new multivariate prognostic models on MELD (model end stage for liver disease)
Measured: Months 3, Month 6, Month 9, Month 12.
Evaluation of the predictive value of the CLIF (Chronic LIver Failure)-C (cirhosis) AD (Decompensation) score in decompensated cirrhotics listed without organ failure
death and drop out
Measured: Months 3, Month 6, Month 9, Month 12.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2019
- Study start2 Oct 2020
- Primary completion6 Nov 2025
- Study completion11 Nov 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Decompensated CirrhosisStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- The pre-inclusion visit will be between 1 week and at the latest 2 days before the inclusion visit. The duration of the inclusion period is 24 months. After inclusion, samples at D5, D10 and D14 (additional samples) for sequential analysis of CRP and ammonemia and simple clinical reassessment will be scheduled for the period of hospitalization or routine consultations. Subsequent scheduled visits will take place quarterly until the transplant. Comprehensive nutritional , frailty and CT assessment of sarcopenia (psoas) by abdominal CT without contrast injection will be performed at 6 months as part of the protocol. Additional visits will be scheduled as part of the usual patient follow-up.
- Masking
- None (open label)
- Enrolment
- 501 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Candy Estevez, Study chair, APHP DRCILaetitia Gregoire, Study chair, APHP URC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03820271
- Sponsor's protocol ID
- K170914J
- Acronym
- SUPERMELD
- Status last verified
- Mar 2026
- First submitted
- 18 Jan 2019
- Last updated
- 12 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Construction of New Predictive Mathematical Models of Mortality in Decompensated Cirrhotic Patients Who Are Candidates for Liver Transplantation
- ClinicalTrials.gov ID
- NCT03820271
- Acronym / sponsor ID
- SUPERMELD / K170914J
- Conditions
- Decompensated Cirrhosis, Liver Transplantation
- Keywords
- Liver transplantation, Predictive prognostic models, Decompensated cirrhosis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 501 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- 2 Oct 2020 (actual)
- Primary completion
- 6 Nov 2025 (actual)
- Study completion
- 11 Nov 2025 (actual)
- First posted
- 29 Jan 2019 (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.
The MELD score is a predictive model of cirrhosis mortality used in France since 2007 to prioritize access to liver transplantation for patients enrolled in the national waiting list. The predictive value of this score was recently revised downward with a C index of the order of 0.65-0.67 and 20% of the patients enrolled for decompensated cirrhosis have access to liver transplantation by a subjective system of "expert component" independent of the MELD because of this lack of precision. The use of the MELD score to individually define access to the transplant should so be reconsidered. Recently new predictive models of cirrhosis mortality better than MELD have been developed and new mortality predictors independent of MELD have been published.
The goal of this study is to design prognostic predictive models of mortality for decompensated cirrhotic patients enrolled on the national liver transplant waiting list including known (MELD, MELD Na) as more recent (CLIF-C AD, CLIF - CACLF) predictive models and new objective predictors studied in combination in order to optimize the system of allocation of hepatic allografts in France.
The expected benefits of this search are twofold:
- At the individual level: The possibility for patients at high risk of death but with intermediate MELD score to be transplanted.
- Public health plan:
- Improving the equity of graft allocation system.
- Decreased mortality in the waiting list by improving the fairness and efficiency of the graft allocation system, a major public health issue
- An ancillary study to the SUPERMELD study is also proposed, the miR MELD study, whose main objective is to evaluate the value of plasma miRNAs in a cohort of patients with decompensated cirrhosis (acute and chronic, excluding cancer) listed for liver transplantation to predict 3-month mortality on the liver transplant waiting list or drop-out from the waitlist for being too sick.
Additional data collection of the vital status 1 year after transplantation of patients initially included in the SUPERMELD study will also be added for all transplanted patients to assess the potential acceleration of access to transplantation for certain candidates at high risk of death prior to transplantation on post-transplantation survival, and assess the transplant benefit.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- The pre-inclusion visit will be between 1 week and at the latest 2 days before the inclusion visit. The duration of the inclusion period is 24 months. After inclusion, samples at D5, D10 and D14 (additional samples) for sequential analysis of CRP and ammonemia and simple clinical reassessment will be scheduled for the period of hospitalization or routine consultations. Subsequent scheduled visits will take place quarterly until the transplant. Comprehensive nutritional , frailty and CT assessment of sarcopenia (psoas) by abdominal CT without contrast injection will be performed at 6 months as part of the protocol. Additional visits will be scheduled as part of the usual patient follow-up.
| Arm | Type | Receives |
|---|---|---|
| SuperMELD | Other | Other: SuperMELD |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Adult patients (≥18 years old) registered on national waiting list with main diagnosis "cirrhosis" within 14 days (+/-2) before or 7 days (+/-2) after the inclusion in the protocol (using the date of biobank sampling as Day 0)
- Patients enrolled on the national waiting list under the "national liver score" allocation scheme whether an expert component is considered or not
- Patients (or trusted person or family member or close relation if the patient is unable to express consent) who have been informed and signed their informed consent
- Patients affiliated to a health insurance scheme
Key exclusion criteria (6 listed)
- Patients enrolled with decompensated cirrhosis associated with hepatocellular carcinoma >TNM1
- Patients on AVK (INR and therefore MELD and CLIF scores uninterpretable)
- Vulnerable population (person under guardianship or curatorship or deprived of liberty by a judicial decision)
- Pregnant and / or breastfeeding woman
- Patient candidate for a combined transplantation
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 |
|---|---|---|
| SuperMELDThe population of this arm will consist of patients newly enrolled in the National Liver Transplantation Waiting List for decompensated cirrhosis, whose liver function and MELD score are assessed at enrollment and then routinely reassessed at least quarterly during the waiting phase. Patients will be followed from their listing to transplantation or discharge or death. | Other | SuperMELD |
Primary outcome
predictive value of the new multivariate prognostic models in patients listed for decompensated cirrhosis
Time frame: Month 3.
Predictive value of mortality and drop out in the waiting list
4 secondary outcomes
Individual predictive value of each of the new candidate predictors
Time frame: Month 3. Month 6, Month 9, Month 12Month 12
Complications predicted by each of the independent predictors
Time frame: Month 3 Month 6, Month 9, Month 12.Month 12
Added predictive value for mortality and drop out of new multivariate prognostic models on MELD (model end stage for liver disease)
Time frame: Months 3, Month 6, Month 9, Month 12.
Evaluation of the predictive value of the CLIF (Chronic LIver Failure)-C (cirhosis) AD (Decompensation) score in decompensated cirrhotics listed without organ failure
Time frame: Months 3, Month 6, Month 9, Month 12.
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 12 Mar 2026.
- Individual participant dataSharing planned: No
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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.
Candy Estevez study chair
APHP DRCI
Laetitia Gregoire study chair
APHP URC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SuperMELD in people with Decompensated Cirrhosis and Liver Transplantation, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
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 4 inclusion and 6 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 12 Mar 2026. 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 France. 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?
predictive value of the new multivariate prognostic models in patients listed for decompensated cirrhosis (time frame: Month 3.). 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 12 Mar 2026.