Orphan Therapeutics has completed enrollment in its pivotal Phase III clinical research study of terlipressin for the treatment of Type 1 hepatorenal syndrome (HRS), a life-threatening complication of liver cirrhosis characterized by rapidly progressive kidney failure. This is the first randomized, double-blind, placebo-controlled clinical trial of terlipressin in HRS in the U.S. and the largest clinical trial ever conducted in HRS.
The study, which is evaluating the safety and the potential effect of terlipressin on kidney function and patient survival in patients with type 1 HRS, has enrolled 112 patients at 30 liver disease centers in the U.S. and five centers outside the U.S. Patients will continue to be followed during the six-month follow-up period. Results from this study are anticipated for release later this year.