Feasibility Pilot Study to Evaluate the Safety and Performance of the MEX-CD1 Medical Device in ACLF

Launched by MEXBRAIN · Mar 25, 2024

Keywords

ClinConnect Summary

This clinical trial is testing a medical device called MEX-CD1, which is designed to help patients with Acute on Chronic Liver Failure (ACLF). The main goals are to see if this device is safe to use and if it effectively removes excess iron from the blood, which can be harmful. Participants will receive the treatment three times within one week, and the study is currently looking for patients aged 18 to 80 who have a history of liver issues and are experiencing serious complications.

To be eligible for this trial, patients must have cirrhosis and be experiencing ACLF grades 2, 3a, or 3b. They should also be on continuous renal replacement therapy, which is a type of treatment for kidney failure. It's important to note that people with certain conditions, like acute liver failure without cirrhosis or those who are pregnant, cannot participate. If you or a loved one qualify, this trial offers a chance to explore a new treatment option while also contributing to important medical research.

Gender

ALL

Eligibility 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