SEPET™ Liver Assist Device, a blood purification technology designed by Arbios Systems, Inc., a Pasadena, CA company, has been given FDA’s Investigational Device Exemption (IDE) status. The clearance paves the way for the company to begin a pivotal clinical trial. The device, a filter with special qualities, is designed for use with a standard blood dialysis system. We first reported about SEPET™ Liver Assist Device back in April 2005.
More about the technology, and the planned trial:
The SEPET™ Liver Assist Device is a novel blood purification therapy designed for use with a standard blood dialysis system. It comprises a sterile, single-use, disposable cartridge containing microporous hollow fibers with unique permeability characteristics. When a patient’s blood is passed through these fibers, blood plasma of specific molecular weight and size is expressed through the micropores, thereby cleansing the blood of harmful impurities (i.e., hepatic failure toxins such as ammonia, as well as various mediators of inflammation and inhibitors of hepatic regeneration). These substances would otherwise progressively accumulate in the patient’s bloodstream during liver failure, accelerating damage to the liver and other organs, including the brain and kidneys, and suppressing the ability of liver cells to function and to proliferate or regenerate.
SEPET™ is further designed to retain in the circulating bloodstream numerous larger, beneficial molecular weight blood proteins, including a powerful promoter of liver regeneration, Hepatocyte Growth Factor (HGF), various immunoglobulins, such as IgG, IgM, and others, and various complement species that are important for retaining active immune protection against infection (which often exacerbates liver failure). SEPET™ also retains most of the blood clotting factors, which are important for preventing bleeding—another common and potentially lethal complication of liver failure…
There are three segments to the pivotal trial design. During the first segment of the trial, 5 non-randomized patients will be treated with SEPET to allow us to validate the patient selection criteria, clinical protocol, case report forms, and other trial related documents. During the second segment of the trial, we expect to enroll 116 patients in this randomized, controlled phase of the trial. This segment is targeted to achieve the co-primary endpoints, which are 1) the percentage of patients achieving improvement in hepatic encephalopathy ("HE") grade by a minimum of two grades by the end of Day 7 in the SEPET treatment group versus the standard medical care group, using a 1:1 randomization between the two groups; and 2) the 30-day transplant free survival rate in all patients (i.e. control and treatment groups) who do reach a two grade Pending review and approval by the Data Safety Monitoring Board, the third segment would permit the size of the trial to be increased by an additional 52 patients, if the co-primary efficacy endpoints are reached or have not reached statistical significance but have shown a positive trend. If the co-primary endpoints of the trial are reached upon completion of segment two, extension of the trial into segment three may result in the achievement of statistical significance of one or more secondary endpoints of the trial relating to clinical, functional, and reimbursement advantages for SEPET-treatment over standard medical care.
To be a candidate for the pivotal trial, a patient must have chronic liver disease and be experiencing an acute episode that results in hospitalization with an HE grade of between II and IV. In addition, the patient must not be responding satisfactorily to standard medical care (e.g. fluid replacement, antibiotics, lactulose) for 20 to 26 hours prior to randomization. Patients contraindicated for a liver transplant (e.g. advanced liver cancer patients and drinking alcoholics) are excluded from the trial.