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

Not Applicable

Recruiting

• Conditions: Acute on Chronic Liver Failure; Multiple Organ Failure

• Registration Number: NCT06340269
• Lead Sponsor: Mexbrain

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2024-3-25
• Last Update Posted: 2 September 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 10

Inclusion Criteria

Inclusion Criteria:<br><br> - Male or female subjects =18 years and =80 years<br><br> - Subject is able to provide informed consent to participate in the study, otherwise<br> written consent must be obtained on behalf of the subject by a next of kin or legal<br> representative in accordance with local ethical and legal requirements<br><br> - History of an acute decompensation event (including but not limited to ascites,<br> gastrointestinal bleeding, hepatic encephalopathy and/or acute bacterial<br> infections), occurring within =6 weeks of screening<br><br> - Cirrhosis (diagnosed based on clinical, biological, morphological parameters or<br> liver biopsy)<br><br> - Subject with:<br><br> - ACLF Grade 2, 3a or 3b based on the CLIF-C OF score<br><br> - Under continuous renal replacement therapy (CRRT) or any organ support device<br> that requires catheter placement<br><br>Exclusion Criteria:<br><br> - Subjects with acute or sub-acute liver failure without an underlying cirrhosis<br><br> - Subjects not considered appropriate for full active treatment including organ<br> support or those with a Do Not Attempt Cardio-Pulmonary Resuscitation order (DNACPR)<br><br> - Subjects who have received any investigational drug or device within 30 days of<br> dosing or who are scheduled to receive another investigational drug or device in the<br> course of the study; concomitant observational studies are allowed<br><br> - Evidence of uncontrolled seizures<br><br> - In females: known pregnancy or lactating<br><br> - Patients with a known allergy to shellfish<br><br> - Patients for who, in the opinion of the investigator, it would be unsafe to be<br> considered for the study<br><br> - Vulnerable population according to Articles 64 to 68 of the Regulations (EU)<br> 2017/745 on Medical Devices<br><br> - Patient with weight < 30 kg

Exclusion Criteria

Not provided

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
SADE for Safety purpose

Secondary Outcome Measures

Name	Time	Method
SAE for Safety purpose;Performance of MEX-CD1;Change in Acute on Chronic Liver Failure (ACLF) Grade;Change in CLIF-C ACLF score;Improvement in individual organ function;Development of secondary infection;Status of ICU;hospital discharge;Mortality