Arbios to initiate pivotal trial for Sepet liver assist device

There are three segments to the pivotal trial design. During the first segment of the trial, five non-randomized patients will be treated with Sepet to validate the patient selection criteria, clinical protocol, case report forms, and other trial related documents.

During the second segment of the trial, the company expects to enroll 116 patients in this randomized, controlled phase of the trial. This segment is targeted to achieve the co-primary endpoints, which are, the percentage of patients achieving improvement in hepatic encephalopathy (HE) grade by a minimum of two grades by the end of day seven in the Sepet treatment group versus the standard medical care group, using a 1:1 randomization between the two groups and the 30-day transplant free survival rate in all patients who do reach a two grade HE improvement versus all patients who do not reach a two grade HE improvement.

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.