Cirrhosis


Predictors and impact of hepatic encephalopathy

Enrollment status: CLOSED – follow-up ongoing

Primary objective

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.

Main inclusion criteria

Main exclusion criteria

Principal investigator: Elliot Tapper, MD • etapper@med.umich.edu

Contact person: Samantha Nikirk• (734) 232-4182 • samjwalk@med.umich.edu


What matters to patients with liver disease?

Enrollment status: OPEN

Primary objective

Cirrhosis is a chronic condition for which there is substantial value in efforts to prevent long-term, costly complications. These include ascites, variceal hemorrhage and, the most devastating, hepatic encephalopathy. Yet, no study to date has asked patients which are the most meaningful outcomes for them, limiting our power to tailor interventions and assess their benefits. We are evaluating several previously unevaluated dimensions of health state utility in patients with cirrhosis using a prospective, cross-sectional survey design via a structured patient interview.

Main inclusion criteria

Main exclusion criteria

Principal investigator: Elliot Tapper, MD - etapper@med.umich.edu

Contact person: Samantha Nikirk - (734) 232-4182 • samjwalk@med.umich.edu


Safety and efficacy of terlipressin in hepatorenal syndrome (HRS) type 1

Enrollment status: OPEN

Objective

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.

Inclusion criteria

Exclusion criteria

For full inclusion and exclusion criteria, please inquire.

Contact person: Pratima Sharma, MD • 734-232-6815 • pratimas@med.umich.edu