No difference seen in 28-day mortality or occurrence of serious adverse events; time to resolution of ACLF significantly faster.
The DIALIVE novel liver dialysis device seems safe and has a positive impact for patients with acute-on-chronic liver failure (ACLF), according to a study published online May 31 in the Journal of Hepatology.
Banwari Agarwal, M.B.B.S., M.D., from the Royal Free Hospital in London, and colleagues examined the safety of DIALIVE in 32 patients with alcohol-related ACLF compared to standard of care (17 with DIALIVE; 15 with standard of care). In the randomized trial, DIALIVE patients were treated for up to five days; at day 10, end points were assessed.
The researchers found that 28-day mortality and occurrence of serious adverse events did not differ significantly between the groups. The DIALIVE group had a significant reduction in the severity of endotoxemia and improvement in albumin function, which translated to a significant reduction in the Chronic Liver Failure consortium (CLIF-C) organ failure and CLIF-C ACLF scores at day 10. The DIALIVE group had significantly faster time to resolution of ACLF. Significant improvement in biomarkers of systemic inflammation, including interleukin-8, cell death, endothelial function, and ligands for Toll-like receptor 4 and inflammasome, was seen in the DIALIVE group.
“These data indicate that DIALIVE may be a disease-modifying therapy for ACLF patients and could impact the outcome of patients with ACLF, for which there is no available therapy except liver transplantation available to a very small minority of these patients,” a coauthor said in a statement. “The potential impact is huge if these data can be confirmed in larger clinical trials.”
Several authors disclosed ties to biotechnology and medical technology companies, including Yaqrit Discovery, which holds the intellectual property for DIALIVE.