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.
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.
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!
Clinical Trials
- Celiac Disease
- Intestinal Failure-Associated Liver Disease
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.
Site: UWMC
Celiac Disease – Interventional
A Randomized, Double-Blind, Placebo-Controlled, Phase 2 Dose-Ranging Study to Evaluate the Efficacy and Safety of TAK-101 for the Prevention of Gluten-Specific T Cell Activation in Subjects with Celiac Disease on a Gluten-Free Diet
This clinical research study is designed to help doctors learn more about a study drug called ‘TAK-101’. The main goals are to find out how well TAK-101 works, how long any effects last, and how safe it is at different dose levels and dose regimens for people with celiac disease when challenged with gluten.
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