This is unpublished

ACTIVE - ENROLLING

Clinical Trials

  • NASH (Non-Alcoholic Steatohepatitis)
  • Cirrhosis (Hepatic Encephalopathy)

Observational Studies

  • Cirrhosis
  • Fatty Liver
  • General Liver Disease
  • Primary Sclerosing Cholangitis

Clinical Trials

NASH Cirrhosis – Interventional

A Randomized Double-blind Placebo-controlled Phase 3 Study to Evaluate the Effect of Resmetirom on Liver-related Outcomes in Patients with Well-compensated (Child-Pugh A) Non-alcoholic Steatohepatitis (NASH) Cirrhosis (MAESTRO-NASH OUTCOMES)

The main purpose of this study is to learn whether treatment with resmetirom compared with a placebo for several years can benefit participants by slowing further disease progression and delaying complications of NASH cirrhosis.

PI: Nicole Kim, MD, MPH

Site: HMC: Main Site, UWMC: Ancillary site

 


Observational Studies

Cirrhosis – Observational

Multicenter Study of Outpatients with Cirrhosis: NACSELD-III

The purpose of this study is to learn more about cirrhosis of the liver and what factors may influence how and why it may become more severe.

PI:Philip B. Vutien, MD

Site: UWMC

 


Cirrhosis – Observational

Evaluating a novel, self-administered device ("Beacon") that measures critical flicker frequency as a test for minimal hepatic encephalopathy in cirrhosis

In this study, we demonstrated that patients with cirrhosis could use Beacon at home to reliably measure their own critical flicker frequency threshold.

PI: George N. Ioannou, MD, MS / James Fogarty

Site: UWMC


General Liver Disease – Observational

A Study of Copper Deficiency in Gastrointestinal and Liver Health 

Copper is an essential trace metal involved in tissue fibrosis, iron metabolism, and innate immunity. The purpose of this research is to understand how copper influences patient outcomes in chronic liver disease. 

PI: Lei Yu, MD

Site: UWMC


Primary Sclerosing Cholangitis – Observational

North American Cholestatic Liver Disease Consortium 

The purpose of this study is to collect biospecimens and clinical data on patients with primary sclerosing cholangitis before and after liver transplantation to better understand the etiology and prognostic factors of this difficult condition. 

PI: Lei Yu, MD

Site: UWMC


ACTIVE – ENROLLMENT COMPLETE

Short Bowel Syndrome

A multicenter, double-blind, randomized, placebo-controlled trial to evaluate the efficacy and safety of apraglutide in adult subjects with short bowel syndrome and intestinal failure (SBS-IF) “STARS”

The purpose of this trial is to find out if the trial medication, apraglutide given as a weekly injection, is able to reduce the volume per week of parenteral support required in adults with short bowel syndrome and intestinal failure. [STOMA arm only]

PI: Lei Yu, MD

Site: UWMC

 


Short Bowel Syndrome

A prospective, multi-center registry for patients with short bowel syndrome (SBS Registry)

The purpose of this registry is to evaluate the long-term safety profile and clinical course for people with short bowel syndrome (SBS) who are treated with teduglutide in a routine clinical setting, as well as those who are not being treated with teduglutide. The primary objective is to determine the occurrence of colorectal cancer in people with SBS with a remnant colon taking or having taken teduglutide. The registry will also evaluate the long-term clinical outcomes in people with SBS.

PI: Lei Yu, MD

Site: UWMC

 

COMING SOON


Celiac Disease - Interventional

A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Dose-Ranging Study to Evaluate the Efficacy and Safety of TAK-062 for the Treatment of Active Celiac Disease in Subjects Attempting a Gluten-Free Diet

This clinical research study is designed to help doctors learn more about a study drug called ‘TAK-062’. The study drug is being developed to be used together with a gluten-free diet for the treatment of celiac disease to determine efficacy and safety.

PI: Isabel Hujoel, MD

Site: UWMC

 


Intestinal Failure-Associated Liver Disease (IFALD)

A Phase 2a, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of NST-6179 in Adult Subjects with Intestinal Failure-Associated Liver Disease (IFALD)

This research study is designed to learn more about the safety and tolerability, pharmacokinetics (PK, how a drug is absorbed by the body and how the drug is broken down and removed from the body), and pharmacodynamics (PD, how a drug impacts the body) of NST-6179 (study drug) given to individuals who have been diagnosed with IFALD.

PI: Lei Yu, MD
Site: UWMC