Testing a new hemodialysis device for patients with acute on chronic liver failure
Feasibility Pilot Study to Evaluate the Safety and Performance of the MEX-CD1 Medical Device in Acute on Chronic Liver Failure (ACLF)
This study is testing a new hemodialysis device to see if it can help patients with acute on chronic liver failure by removing excess iron from their blood and improving their condition.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 10 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | Mexbrain Industry-sponsored |
| Locations | 2 sites (Lyon, Rhône-Alpes and 1 other locations) |
| Trial ID | NCT06340269 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the safety and performance of the MEX-CD1 hemodialysis device in patients suffering from acute on chronic liver failure (ACLF). Participants will undergo three sessions of slow low volume continuous venovenous hemodialysis (CVVHD) within one week. The study aims to determine if the device effectively removes excess free iron from the blood, which may help reduce inflammation and prevent further organ failure. The ultimate goal is to improve the condition of ACLF patients and potentially restore their eligibility for liver transplantation.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 to 80 with a diagnosis of cirrhosis and ACLF grade 2, 3a, or 3b who are undergoing continuous renal replacement therapy.
Not a fit: Patients with acute or sub-acute liver failure without underlying cirrhosis or those not suitable for active treatment will not benefit from this study.
Why it matters
Potential benefit: If successful, this device could significantly improve outcomes for patients with ACLF by reducing inflammation and organ failure.
How similar studies have performed: While the approach of using hemodialysis to manage ACLF is innovative, similar studies have shown promise in addressing complications associated with liver failure.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Exclusion Criteria: * 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 * 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
Where this trial is running
Lyon, Rhône-Alpes and 1 other locations
- Hôpital Croix Rousse, Service d'hépatologie et gastroentérologie — Lyon, Rhône-Alpes, France (Recruiting)
- CHU Pontchaillou — Rennes, France (Recruiting)
Study contacts
- Principal investigator: Céline GUICHON, MD — Hôpital Croix Rousse, Service d'hépatologie et gastroentérologie
- Study coordinator: Karen GILLANT
- Email: Karen.gillant@MEXBRAIN.COM
- Phone: +33674152663
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.