Feasibility Pilot Study to Evaluate the Safety and Performance of the MEX-CD1 Medical Device in Acute on Chronic Liver Failure (ACLF)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Mexbrain
- 入组人数
- 11
- 试验地点
- 4
- 主要终点
- SADE for Safety purpose
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
MEX-CD1 Slow Low volume CVVHD
Patients enrolled in the treatment arm will receive 3 sessions of MEX-CD1 treatment in addition to standard of care
干预措施: MEX-CD1 Dialysis (Device)
结局指标
主要结局
SADE for Safety purpose
时间窗: 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.
次要结局
- hospital discharge(Between the screening visit and the last visit, assessed up to 28 days.)
- Mortality(Between the screening visit and the last visit, assessed up to 28 days.)
- Performance of MEX-CD1(3 hours and 20 minutes; from treatment start (0 hours) to treatment end (3h20))
- Change in Acute on Chronic Liver Failure (ACLF) Grade(Between the screening visit and the last visit, assessed up to 7 days.)
- Change in CLIF-C ACLF score(Between the screening visit and the last visit, assessed up to 7 days.)
- Improvement in individual organ function(Between the screening visit and the last visit, assessed up to 7 days.)
- Status of ICU(Between the screening visit and the last visit, assessed up to 28 days.)
- SAE for Safety purpose(From the start of the first MEX-CD1 treatment until the last visit, assessed up to 7 days.)
- Development of secondary infection(Between the screening visit and the last visit, assessed up to 7 days.)