Ikaria announced the enrollment of the first patients in its Phase 3 study of Lucassin (terlipressin for injection) for the treatment of hepatorenal syndrome (HRS) Type 1. This trial, known as the REVERSE trial, is a multi-center, randomized, placebo-controlled, double-blind study. It will have a primary endpoint of HRS reversal, which is defined as two serum creatinine values of less than or equal to 1.5 mg/dL taken at least 48 hours apart, without any intervening hemodialysis, transplant or elevation of creatinine above a pre-specified level. Transplant-free survival and overall survival are among the secondary endpoints of the trial.
Lucassin is a synthetic vasopressin analogue that acts via the vasopressin V1 receptor as a systemic vasoconstrictor, mainly in the splanchnic (abdominal) circulation, which appears to increase effective arterial volume and improves renal blood flow, thereby improving renal function in patients with HRS.
For more information call (908) 238-6600 or visit www.ikaria.com.