VTL-308 Clinical Study

VTL-308, A Randomized, Open-Label, Multicenter, Controlled, Pivotal Study to Assess Safety and Efficacy of ELAD® in Subjects with Alcohol-Induced Liver Decompensation (AILD).

Study Objectives:

The primary objective of the study is to evaluate safety and efficacy of ELAD® with respect to overall survival (OS) of subjects with a clinical diagnosis of alcohol-induced liver decompensation (AILD).

Subjects will be followed through at least Study Day 91 and an extension study (Protocol VTL-308E) will provide additional survival data up to a maximum of 5 years.

Study Design:

VTL-308 is a randomized, open-label, multicenter, controlled, pivotal study of subjects with AILD.

A minimum of 150 subjects meeting the eligibility requirements of the study will be randomly assigned in a 1:1 ratio to receive either standard of care treatment for AILD plus treatment with the ELAD® System (ELAD® group) or standard of care treatment for AILD alone (control group). Subjects randomized to receive treatment with the ELAD® closed-loop system will have blood withdrawn and returned with a blood pump via a dual-lumen catheter.

ELAD® treatment is continuous with a minimum duration of 3 days (72 hours) and lasting up to 5 days (120 hours); exact treatment duration will be the responsibility of the physician (principal investigator and/or sub-investigators) to determine. Vital Therapies, Inc. provides continuous ELAD® System monitoring and maintenance by trained ELAD® specialists. Subjects will remain under continuous observation during treatment.

Please complete the study pre-screener to evaluate patient eligibility in this clinical trial.

The ELAD® System Concept

ELAD®, being studied in this phase 3 clinical study, is an investigational extracorporeal human hepatic cell-based liver support system designed with the proposed intent to supplement key aspects of normal liver function in order to improve survival among patients with liver failure secondary to acute hepatocellular insult and alcohol use.

ELAD® is a closed-loop system that consists of an ancillary delivery device attached to four disposable hollow-fiber cartridges, which collectively contain approximately 440 grams of VTL C3A cells.

During treatment with ELAD®, blood is withdrawn from the subject via a dual-lumen catheter placed in a large vein. The plasma fluid, ultrafiltrate (UF), is separated from cellular components using a specifically-designed UF generator. The UF is then continuously circulated through the hollow-fiber cartridges. The semipermeable membrane of the cartridge permits bidirectional flow between the cells, which are grown in the extra-capillary space between the hollow fibers, and the UF, which flows through the intra-capillary space of the hollow fibers. Toxins, nutrients and dissolved oxygen pass from the UF to the cells while macromolecules and other substances synthesized by the cells simultaneously pass into the subject's UF, which is then recombined with the blood and returned to the subject via the dual-lumen catheter. Temperature, pH and oxygen concentrations in the UF are monitored continuously within the circuit in order to ensure the cells’ viability during treatment.

Please complete the study pre-screener to evaluate patient eligibility in this clinical trial. [ CLICK HERE ]

Any questions contact: AAHStudy@imperialcrs.com