Clinical Trials

The purpose of this study is to identify consensus among clinicians about the definitions, perceptions and practices for management of dominant strictures in primary sclerosing cholangitis.

The purpose of this study is to determine the incidence of rPSC in LT recipients treated with fenofibrate, compared with an untreated control cohort.

This is a single-arm, open label, proof of concept (PoC) study of Cenicriviroc (CVC) in adult subjects with Primary Sclerosing Cholangitis (PSC). The main objective of this PoC study is to assess changes in alkaline phosphatase (ALP) both individually and as a group, over 24 weeks of treatment with CVC.

Develop an appropriate real-world data comparator cohort to support the design, execution, and serve as an external control for interventional clinical trials in PSC.

The objectives of this study are to establish and perpetuate human biliary cell-derived organoids, to assess genetic and signaling pathway alterations in organoids derived from PSC patients as compared to Non-PSC patients, and to investigate the potential utility of organoids in the in vitro testing of experimental drugs.

The purpose of this study is to evaluate the safety and effect of obeticholic acid on liver biochemistry, in particular, serum alkaline phosphatase, in patients with primary sclerosing cholangitis.

The purpose of this study is to evaluate the effectiveness and safety of obeticholic acid in patients with primary sclerosing cholangitis, evaluating its effects on specific liver function indicators and biochemistry.

Primary sclerosing cholangitis is a chronic inflammation of the bile ducts of unknown cause and eventually results in cirrhosis of the liver. These patients are at increased risk for the development of cancer rising from bile duct tissue. Chromosomal abnormalities of the bile duct tissue, particularly trisomy 7 (i.e. three copies of chromosome 7) can be detected in biopsy samples. Erlotinib (Tarceva) is a human EGFR type 1 tyrosine kinase inhibitor and offers greater survival benefit to EGFR positive patients. This study will assist in determining the safety and tolerability of Tarceva in patients who have primary sclerosing cholangitis.

The purpose of this study is to evaluate the safety, tolerability, and effectiveness of GS-9674 in adults who have primary sclerosing cholangitis.

The purpose of this study is to determine if there are differences in the metabolites (enzymes and other proteins) found in portal venous blood (blood in the portal vein, which delivers blood from the intestines to the liver), peripheral venous blood, and bile between individuals with liver disease undergoing liver transplantation and healthy donors. With this information, we may be able to better understand the importance and nature of the relationship between the gut (i.e. intestines) and the liver in the context of liver disease and identify pathways which may lead to the development of new and improved therapies for ...

This study is a biobank of specimens and clinical data for use in current and future research to better understand the cholestatic liver diseases primary biliary cirrhosis/cholangitis (PBC) and primary sclerosing cholangitis (PSC).

The overall objective of this proposal is to conduct a systematic approach to dissect both genetic underpinnings and non-genetic factors in the development of adult autoimmune liver diseases including autoimmune hepatitis (AIH), overlap AIH with Primary Biliary Cirrhosis (AIH-PBC), overlap AIH with Primary Sclerosing Cholangitis (AIH-PSC), and drug-induced autoimmune-like hepatitis (DIAIH).

The purpose of this research study is to improve our understanding of normal liver and gallbladder function and liver and gallbladder diseases including PBC, PSC, ADPKD (Autosomal Dominant Polycystic Kidney Disease), and ARPKD (Autosomal Recessive Polycystic Kidney Disease) and gallbladder inflammation (cholecystitis).

The purpose of this study is to establish the Maximum Tolerated Dose (MTD), assess the safety, tolerability, and pharmacokinetics of subcutaneous PHIN-214 in participants with compensated and decompensated cirrhosis. In addition, various exploratory markers of effectiveness will be analyzed. 

The purpose of this study is to facilitate discovery and development of novel biomarkers of risk and early detection, etiologic factors relating to liver disease, and novel targeted therapeutic and chemopreventive strategies for liver disease such as PSC, PBC, PLD, NAFLD, NASH, ASH, HCC, donors (non-diseased and diseased) for liver transplant or non-liver diseased subjects scheduled for surgery will serve as controls.

We purpose of this study is to evaluate the diagnosis accuracy of the Controlled Attenuation Parameter (CAP) measured by FibroScan® (both with M and XL probes) in all patients who are undergoing liver biopsy for any liver disease.