Michael D. Leise, M.D.

Closed for Enrollment

• A Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial To Evaluate The Efficacy, Safety, And Pharmacokinetics Of Rifaximin 550 Mg In Subjects With Severe Hepatic Impairment And Overt Hepatic Encephalopathy Rochester, Minn.

  The purpose of the study is to evaluate the safety of Rifaximin or placebo in subjects with severe hepatic impairment and Hepatic Encephalopathy.

• A Single Arm, Open-label Study To Evaluate The Efficacy And Safety Of Glecaprevir (GLE)/Pibrentasvir (PIB) In Treatment Naïve Adults With Chronic Hepatitis C Virus (HCV) Genotype 1, 2, 4, 5 Or 6 Infection And Compensated Cirrhosis Scottsdale/Phoenix, Ariz., Rochester, Minn.

  A Phase 3b, single arm, open-label, multicenter study to evaluate the safety and to demonstrate the non-inferiority of the sustained virologic response 12 weeks post dosing (SVR12) rates of 8 weeks of treatment with the glecaprevir (GLE)/pibrentasvir (PIB) combination regimen to the historical SVR12 rate of 12 weeks of treatment with the GLE/PIB in treatment-naïve adults with chronic HCV GT 1, 2, 4, 5, or 6 infection and compensated cirrhosis.

• Pilot Study for the Use of Hepatitis C Virus Seropositive Donors into Hepatitis C Seronegative Liver Transplant Recipients Scottsdale/Phoenix, Ariz., Rochester, Minn., Jacksonville, Fla.

  The purpose of this study is to utilize liver allografts from HCV seropositive donors into 10 HCV seronegative recipients. 

• The HepQuant SHUNT Liver Diagnostic Kit for Likelihood of Large Esophageal Varices: The SHUNT-V Study Rochester, Minn., Jacksonville, Fla.

  The purpose of this study is to validate the Disease Severity Index (DSI) from the HepQuant SHUNT Liver Diagnostic Kit (Test) for likelihood of large esophageal varices.