Mallinckrodt plc. to present results from its pivotal phase 3 confirm study of terlipressin in patients with hepatorenal syndrome type 1 (hrs-1) at the liver meeting 2019

Mallinckrodt plc announced it will present results from its pivotal phase 3 confirm study in a late-breaker session on november 11 at 3:30 pm et during the liver meeting 2019, the annual meeting of the american association for the study of liver diseases (aasld) in boston. the confirm clinical trial assessed the efficacy and safety of terlipressin in 300 adults with hepatorenal syndrome type 1 (hrs-1), an acute and life-threatening syndrome involving acute kidney failure in people with cirrhosis. confirm is the largest prospective trial ever conducted in this patient population. mallinckrodt announced in august that the study met its primary endpoint of verified hrs-1 reversal (p=0.012). 'verified hrs-1 reversal' is a term denoting three components: renal function improvement, avoidance of dialysis and short-term survival. the company plans to submit a new drug application to the u.s. food and drug administration in early 2020. terlipressin is an investigational product and its safety and effectiveness have not yet been established by the fda or health canada. hrs-1 has a very poor prognosis, with a median survival of less than two weeks and greater than 80% mortality within three months if left untreated. at present, there are no approved drug therapies for hrs-1 in the u.s. or canada. about the pivotal phase 3 confirm study (multi-center, randomized, placebo-controlled, double-blind trial in the u.s. and canada): the trial was designed to confirm efficacy and safety of terlipressin for the treatment of hrs-1. confirm is the largest prospective trial ever conducted (n=300) in hrs-1 patients. eligibility criteria included adults with liver cirrhosis and ascites with rapidly worsening renal function and no response to diuretics or albumin. subjects were randomized in a 2:1 ratio to receive terlipressin plus albumin (n=199) or placebo plus albumin (n=101). the primary endpoint of verified hrs reversal was intended to evaluate renal function improvement, avoidance of dialysis and short-term survival.
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