Date: 2014-07-09
Type of information: Interim results
phase: 3
Announcement: update of the trial
Company: Vital Therapies (USA - CA)
Product: Elad® (Extracorporeal Liver Assist Device)
Action
mechanism: Elad® is an extracorporeal bio-artificial liver therapy currently in Phase 3 clinical trials. It is designed with the proposed intent to allow the patient’s own liver to regenerate to a healthy state, or to stabilize the patient until liver transplant. The device incorporates human liver-derived cells (VTL C3A cells), contained in four hollow fiber cartridges that are combined with single use customized disposable sets and a reusable ancillary delivery system. During Elad® System therapy, blood is drawn from the patient via a central venous line and then passes into the ancillary delivery system where plasma ultrafiltrate is isolated by an ultrafiltrate generator. The patient’s plasma ultrafiltrate then passes into the four cartridges where it contacts VTL C3A cells after passing through fibers which allow appropriate two-way transfer of toxins, metabolites and nutrients, mimicking liver function. The fibers, made of a semi-permeable membrane, permit passage of macromolecules and other substances from VTL C3A cells to the patient’s plasma ultrafiltrate. At the same time, these fibers permit the passage of toxins such as bilirubin, and nutrients such as glucose, from the plasma ultrafiltrate to our VTL C3A cells. Treated plasma ultrafiltrate is then filtered, reconstituted with blood cells and returned to the patient via the central venous line. Meanwhile, the ancillary delivery system monitors temperature, pH, and oxygen concentrations in the plasma ultrafiltrate in order to maintain the cells’ viability.
Disease: alcohol induced liver decompensation acute alcoholic hepatitis
Therapeutic area: Hepatic diseases - Liver diseases
Country: Australia, Spain, UK, USA
Trial details:
Latest
news: * On July 9, 2014, Vital Therapies, a biotherapeutic company developing Elad®, a cell-based therapy targeting treatment of acute liver failure, is providing this update on the status of its clinical trials and the EMA\'s response to its request for advice through the Scientific Advice Working Party (SAWP) process. As of today, 123 of a targeted 200 subjects have been enrolled in VTI-208, a randomized, controlled Phase 3 clinical trial in alcohol induced liver decompensation. Enrollment rates remain consistent with priorprojections, and preliminary results are expected in the first half of 2015. Forty-eight clinical sites are now open in the USA, UK, Spain and Australia, and 37 sites have enrolled at least one subject.
The second randomized, controlled, Phase 3 clinical trial, VTI-210, is studying the use of ELAD in subjects with acute alcoholic hepatitis (AAH) who have failed steroid therapy. As part of the process for preparing for a possible European Marketing Authorization Application (MAA) based primarily on VTI-210, Vital Therapies submitted a request earlier this year for SAWP advice on topics relating to the production and testing section of a future MAA, and on aspects of VTI-210 protocol design. The company plans to amend the protocol consistent with this guidance, and also to explore an event-driven design with a minimum of 150 subjects. Four sites are currently open for enrollment, but the first subject has not yet been enrolled. Assuming a 150 patient trial, preliminary results from VTI-210 are expected to be available in 2016.
The final ongoing clinical trial is VTI-212. As previously disclosed, VTI-212 is being modified into a single-arm, open-label, multi-center Phase 2 clinical trial expected to enroll at least 40 subjects with fulminant hepatic failure or surgery induced liver failure, all of whom will be treated with the company\'s ELAD System, plus standard-of-care. Treated subjects will be compared with case-controlled subjects treated with standard-of-care alone. Enrollment in VTI-212 is underway and results from VTI-212 are expected in 2015 or 2016.
