To determine the predictors of hepatic encephalopathy (HE) in people with cirrhosis followed for up to 3 years. We are evaluating the usefulness of new biomarkers and risk factors that may help to predict the development of HE. If we predict HE, something for which tools are currently lacking, this information could be used to develop preventive interventions.
Principal investigator: Elliot Tapper, MD • email@example.com
Contact person: Jane Wong • (734) 232-0284 • firstname.lastname@example.org
This is a phase 3, randomized, double-blind, placebo-controlled, multicenter trial to confirm the safety and efficacy of terlipressin in subjects with hepatorenal syndrome (HRS) type 1. HRS type 1 is a rare condition that can occur in patients with cirrhosis, decompensated liver disease, and portal hypertension. HRS type 1 is characterized by rapid progressive renal injury and has a very poor prognosis with >80% mortality within 3 months. At present, there are no approved drug therapies for HRS type 1 in the United States or Canada. The only cure for HRS type 1 and the underlying end-stage cirrhosis is liver transplantation; however, many patients will not survive long enough to receive a liver transplant. Terlipressin is an investigational vasoconstrictive drug that may improve renal function in patients with HRS type 1. There is substantial data available from many published clinical investigations that provide compelling evidence of terlipressin's efficacy in patients with HRS type 1.
Michigan Medicine is one of sites that is actively enrolling subjects for this clinical trial. A total of 300 subjects are planned to be enrolled at about 70 sites in the United States and Canada. For more information about this trial, please see https://clinicaltrials.gov/ct/show/NCT02770716.
For full inclusion and exclusion criteria, please inquire.