Acute on Chronic Liver FailureMexACLFNCT06340269
Feasibility Pilot Study to Evaluate the Safety and Performance of the MEX-CD1 Medical Device in ACLF
A study testing MEX-CD1 Dialysis in people with Acute on Chronic Liver Failure and Multiple Organ Failure, run by Mexbrain at 2 sites in France.
Trial summary
The goal of this clinical trial is to test the MEX-CD1 hemodialysis medical device in patients suffering from ACLF. The main questions it aims to answer are: Is the device safe when used according to the instructions for use? Does the device work as expected by removing the excess of free iron from the blood? Patients… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Acute on Chronic Liver Failure, Multiple Organ Failure
- What is being tested?
- MEX-CD1 Dialysis
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 11 participants
- Where
- 2 sitesFrance
- Study dates
- 21 Jun 2024to 23 Oct 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female subjects ≥18 years and ≤80 years
- Subject is able to provide informed consent to participate in the study, otherwise written consent must be obtained on behalf of the subject by a next of kin or legal representative in accordance with local ethical and legal requirements
- History of an acute decompensation event (including but not limited to ascites, gastrointestinal bleeding, hepatic encephalopathy and/or acute bacterial infections), occurring within ≤6 weeks of screening
- Cirrhosis (diagnosed based on clinical, biological, morphological parameters or liver biopsy)
- Subject with:
- ACLF Grade 2, 3a or 3b based on the CLIF-C OF score
- Under continuous renal replacement therapy (CRRT) or any organ support device that requires catheter placement
Who cannot join
- Subjects with acute or sub-acute liver failure without an underlying cirrhosis
- Subjects not considered appropriate for full active treatment including organ support or those with a Do Not Attempt Cardio-Pulmonary Resuscitation order (DNACPR)
- Subjects who have received any investigational drug or device within 30 days of dosing or who are scheduled to receive another investigational drug or device in the course of the study; concomitant observational studies are allowed
- Evidence of uncontrolled seizures
- In females: known pregnancy or lactating
- Patients with a known allergy to shellfish
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- Patients for who, in the opinion of the investigator, it would be unsafe to be considered for the study
- Vulnerable population according to Articles 64 to 68 of the Regulations (EU) 2017/745 on Medical Devices
- Patient with weight < 30 kg
Trial locations and contacts
2 sites in 1 country.
France2 sites
Hôpital Croix Rousse, Service d'hépatologie et gastroentérologie
Lyon, Auvergne-Rhône-Alpes, 69317
CHU Pontchaillou
Rennes, 35000
About this study
Official title: Feasibility Pilot Study to Evaluate the Safety and Performance of the MEX-CD1 Medical Device in Acute on Chronic Liver Failure (ACLF)
The goal of this clinical trial is to test the MEX-CD1 hemodialysis medical device in patients suffering from ACLF. The main questions it aims to answer are:
- Is the device safe when used according to the instructions for use?
- Does the device work as expected by removing the excess of free iron from the blood?
Patients will receive 3 MEX-CD1 Slow Low volume CVVHD within 1 week.
Read the detailed description
This study investigates the safety and performance of the MEX-CD1 slow low volume CVVHD device in patients suffering from ACLF.
Acute-on-chronic liver failure (ACLF) is defined as a syndrome in patients with acutely decompensated cirrhosis, associated with single or multiple organ failures, and characterized by a high short-term mortality. ACLF is frequently triggered by a precipitating event (alcoholic hepatitis, infection, gastrointestinal haemorrhage) and characterized by an intense systemic inflammatory response driven per pathogen-associated molecular patterns (PAMPs) and/or damage-associated molecular patterns (DAMPs) responsible of the development of organs failure through tissues hypoperfusion, immune-mediated tissue damages and mitochondrial dysfunction.
Very importantly, ACLF is a very dynamic syndrome that has potential for reversibility. It is hypothesized that the extraction of non-transferrin bound iron (NTBI) could break down the vicious cycle of the excessive inflammatory responses, reduce oxidative stress and inhibit pathogen proliferation in ACLF patients.
As a consequence, it is hypothesized that the extraction of NTBI could promote improvement of ACLF grade n to ACLF grade n-1 or no ACLF. It is hypothesized that the extraction of NTBI could stop the progression of ACLF by preventing further organ failures and by reducing bacterial infection. Thereby, the extraction of NTBI could restore the eligibility of ACLF patients to liver transplantation, and, with or without liver transplantation, allow an earlier discharge from intensive care and prolong survival.
The proposed medical device, by combining dialysis to a hyper-chelating colloidal dialysate (MEX-CD1), specifically extracts free iron from the blood.
All patients enrolled in this study will receive 3 MEX-CD1 Slow Low volume CVVHD within 1 week. The duration of each MEX-CD1 Slow Low volume CVVHD session is 3h20.
- Being tested
- MEX-CD1 Dialysis
- Keywords
- ACLF, Intensive Care Unit, Iron, Hemodialysis
- Medical subject headings
- Acute-On-Chronic Liver Failure, Multiple Organ Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MEX-CD1 DialysisDevice
Also called Slow Low-volume continuous veno-venous haemodialysis
MEX-CD1 is a hyper-chelating colloidal solution that can be added to the dialysate to be used in Slow low-volume continuous veno-venous hemodialysis. One treatment will last 3 hours and 20 minutes.
Patients enrolled are hospitalized in Intensive Care Unit.
| Study group | Role | What they receive |
|---|---|---|
| MEX-CD1 Slow Low volume CVVHD | Experimental | Patients enrolled in the treatment arm will receive 3 sessions of MEX-CD1 treatment in addition to standard of care Receives: Device: MEX-CD1 Dialysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
SADE for Safety purpose
The safety will be assessed by percentage of subjects who discontinued MexACLF due to a serious adverse device event (SADE) between Day 1 and Day 7.
Measured: From the enrollment until the last visit, assessed up to 7 days.
Secondary outcomes (9)
SAE for Safety purpose
The safety will be assessed by the percentage of patients who experience at least one related Serious Adverse Event (SAE) between Day 1 and Day 7.
Measured: From the start of the first MEX-CD1 treatment until the last visit, assessed up to 7 days.
Performance of MEX-CD1
The performance of the MEX-CD1 slow low-volume CVVHD treatment in terms of iron extraction will be measured by the amount of iron extracted in the dialysate bags per treatment.
Measured: 3 hours and 20 minutes; from treatment start (0 hours) to treatment end (3h20)
Change in Acute on Chronic Liver Failure (ACLF) Grade
Assessment of the change in ACLF Grade between the baseline and the end of study Min value = 0 (no ACLF) Max value=3b (Worse outcome)
Measured: Between the screening visit and the last visit, assessed up to 7 days.
Change in CLIF-C ACLF score
Assessment of the change in Chronic Liver Failure-Consortium (CLIF-C) ACLF score between the baseline and the end of study. CLIF-C ACLF = 10 × (0.33 × CLIF-C OFs + 0.04 x Age + 0.63 × ln (WBC count)-2)
CLIF-OFs= Chronic Liver Failure Consortium Organe Failure Min value=6 (No organe Failure) Max value=18 (6 organe failures)
Measured: Between the screening visit and the last visit, assessed up to 7 days.
Improvement in individual organ function
Assessment of the change in individual organ function by using the CLIF sequential OF score
From 1 (no organe failure) to 3 (worse outcome) for the 6 organes below:
Liver ; kidney ; Brain ; Coagulation ; Circulation ; Respiratory
Measured: Between the screening visit and the last visit, assessed up to 7 days.
Development of secondary infection
Assessment of development of secondary infection by need for new antibiotic therapy
Measured: Between the screening visit and the last visit, assessed up to 7 days.
Status of ICU
Length of stay in ICU
Measured: Between the screening visit and the last visit, assessed up to 28 days.
hospital discharge
Length of stay at hospital
Measured: Between the screening visit and the last visit, assessed up to 28 days.
Mortality
Assessment of the survival rate
Measured: Between the screening visit and the last visit, assessed up to 28 days.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2024
- Study start21 Jun 2024
- Primary completion23 Oct 2025
- Study completion23 Oct 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute on Chronic Liver FailureStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Prospective, national, monocentric, single-arm, open label, feasibility pilot clinical trial.
- Masking
- None (open label)
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mexbrain
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Slb Pharma
- Responsible party
- Sponsor
- Investigators
- Céline GUICHON, MD, Principal investigator, Hôpital Croix Rousse, Service d'hépatologie et gastroentérologie
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06340269
- Sponsor's protocol ID
- PJ2308-0025
- Acronym
- MexACLF
- Status last verified
- Apr 2026
- First submitted
- 25 Mar 2024
- Last updated
- 29 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility Pilot Study to Evaluate the Safety and Performance of the MEX-CD1 Medical Device in Acute on Chronic Liver Failure (ACLF)
- ClinicalTrials.gov ID
- NCT06340269
- Acronym / sponsor ID
- MexACLF / PJ2308-0025
- Keywords
- ACLF, Intensive Care Unit, Iron, Hemodialysis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 11 participants (actual)
- Lead sponsor
- MexbrainIndustry (pharma, biotech, devices)
- Collaborators
- Slb Pharma
- Study start
- 21 Jun 2024 (actual)
- Primary completion
- 23 Oct 2025 (actual)
- Study completion
- 23 Oct 2025 (actual)
- First posted
- 1 Apr 2024 (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 goal of this clinical trial is to test the MEX-CD1 hemodialysis medical device in patients suffering from ACLF. The main questions it aims to answer are:
- Is the device safe when used according to the instructions for use?
- Does the device work as expected by removing the excess of free iron from the blood?
Patients will receive 3 MEX-CD1 Slow Low volume CVVHD within 1 week.
Detailed description
This study investigates the safety and performance of the MEX-CD1 slow low volume CVVHD device in patients suffering from ACLF.
Acute-on-chronic liver failure (ACLF) is defined as a syndrome in patients with acutely decompensated cirrhosis, associated with single or multiple organ failures, and characterized by a high short-term mortality. ACLF is frequently triggered by a precipitating event (alcoholic hepatitis, infection, gastrointestinal haemorrhage) and characterized by an intense systemic inflammatory response driven per pathogen-associated molecular patterns (PAMPs) and/or damage-associated molecular patterns (DAMPs) responsible of the development of organs failure through tissues hypoperfusion, immune-mediated tissue damages and mitochondrial dysfunction.
Very importantly, ACLF is a very dynamic syndrome that has potential for reversibility. It is hypothesized that the extraction of non-transferrin bound iron (NTBI) could break down the vicious cycle of the excessive inflammatory responses, reduce oxidative stress and inhibit pathogen proliferation in ACLF patients.
As a consequence, it is hypothesized that the extraction of NTBI could promote improvement of ACLF grade n to ACLF grade n-1 or no ACLF. It is hypothesized that the extraction of NTBI could stop the progression of ACLF by preventing further organ failures and by reducing bacterial infection. Thereby, the extraction of NTBI could restore the eligibility of ACLF patients to liver transplantation, and, with or without liver transplantation, allow an earlier discharge from intensive care and prolong survival.
The proposed medical device, by combining dialysis to a hyper-chelating colloidal dialysate (MEX-CD1), specifically extracts free iron from the blood.
All patients enrolled in this study will receive 3 MEX-CD1 Slow Low volume CVVHD within 1 week. The duration of each MEX-CD1 Slow Low volume CVVHD session is 3h20.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Prospective, national, monocentric, single-arm, open label, feasibility pilot clinical trial.
| Arm | Type | Receives |
|---|---|---|
| MEX-CD1 Slow Low volume CVVHD | Experimental | Device: MEX-CD1 DialysisPatients enrolled in the treatment arm will receive 3 sessions of MEX-CD1 treatment in addition to standard of care |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Male or female subjects ≥18 years and ≤80 years
- Subject is able to provide informed consent to participate in the study, otherwise written consent must be obtained on behalf of the subject by a next of kin or legal representative in accordance with local ethical and legal requirements
- History of an acute decompensation event (including but not limited to ascites, gastrointestinal bleeding, hepatic encephalopathy and/or acute bacterial infections), occurring within ≤6 weeks of screening
- Cirrhosis (diagnosed based on clinical, biological, morphological parameters or liver biopsy)
- Subject with:
Key exclusion criteria (9 listed)
- Subjects with acute or sub-acute liver failure without an underlying cirrhosis
- Subjects not considered appropriate for full active treatment including organ support or those with a Do Not Attempt Cardio-Pulmonary Resuscitation order (DNACPR)
- Subjects who have received any investigational drug or device within 30 days of dosing or who are scheduled to receive another investigational drug or device in the course of the study; concomitant observational studies are allowed
- Evidence of uncontrolled seizures
- In females: known pregnancy or lactating
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 |
|---|---|---|
| MEX-CD1 DialysisAlso: Slow Low-volume continuous veno-venous haemodialysisMEX-CD1 is a hyper-chelating colloidal solution that can be added to the dialysate to be used in Slow low-volume continuous veno-venous hemodialysis. One treatment will last 3 hours and 20 minutes. Patients enrolled are hospitalized in Intensive Care Unit. | Device | MEX-CD1 Slow Low volume CVVHD |
Primary outcome
SADE for Safety purpose
Time frame: From the enrollment until the last visit, assessed up to 7 days.
The safety will be assessed by percentage of subjects who discontinued MexACLF due to a serious adverse device event (SADE) between Day 1 and Day 7.
9 secondary outcomes
SAE for Safety purpose
Time frame: From the start of the first MEX-CD1 treatment until the last visit, assessed up to 7 days.
Performance of MEX-CD1
Time frame: 3 hours and 20 minutes; from treatment start (0 hours) to treatment end (3h20)
Change in Acute on Chronic Liver Failure (ACLF) Grade
Time frame: Between the screening visit and the last visit, assessed up to 7 days.
Change in CLIF-C ACLF score
Time frame: Between the screening visit and the last visit, assessed up to 7 days.
Improvement in individual organ function
Time frame: Between the screening visit and the last visit, assessed up to 7 days.
Development of secondary infection
Time frame: Between the screening visit and the last visit, assessed up to 7 days.
Status of ICU
Time frame: Between the screening visit and the last visit, assessed up to 28 days.
hospital discharge
Time frame: Between the screening visit and the last visit, assessed up to 28 days.
Mortality
Time frame: Between the screening visit and the last visit, assessed up to 28 days.
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 29 Apr 2026.
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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.
Céline GUICHON, MD principal investigator
Hôpital Croix Rousse, Service d'hépatologie et gastroentérologie
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MEX-CD1 Dialysis in people with Acute on Chronic Liver Failure and Multiple Organ Failure, run by Mexbrain at 2 sites 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 7 inclusion and 9 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 29 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
SADE for Safety purpose (time frame: From the enrollment until the last visit, assessed up to 7 days.). 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 29 Apr 2026.