Liver Cirrhosis Network Cohort Study
CirrhosisCirrhosis11 moreLiver Cirrhosis Network (LCN) Cohort Study is an observational study designed to identify risk factors and develop prediction models for risk of decompensation in adults with liver cirrhosis. LCN Cohort Study involves multiple institutions and an anticipated 1200 participants. Enrolled participants will have study visits every 6 months (180 days), with opportunities to complete specific visit components via telehealth or remotely. Visits will include collection of questionnaire data and the in-person visits will include questionnaires, physical exams, imaging, and sample collection.
Study of [14C]CS0159 in China Healthy Subjects
Primary Biliary CholangitisStudy of [14C]CS0159 in China Healthy Subjects.
A Study of Baricitinib (LY3009104) in Participants With Primary Biliary Cholangitis Who do Not Respond...
Primary Biliary CholangitisThis study evaluates the safety and efficacy of baricitinib in participants with primary biliary cholangitis (PBC) who do not respond or are unable to take ursodeoxycholic acid (UDCA).
Study to Evaluate the Safety and Efficacy of Oral CR845 (Difelikefalin) in Patients With Primary...
Cholestatic PruritusThis is a multicenter, randomized, double-blind, placebo-controlled study to evaluate the safety and efficacy of twice-daily (BID) oral CR845 1.0 mg in patients with PBC with moderate-to-severe pruritus. The study includes a 16-week Treatment Period.
Phase 4 Study of Obeticholic Acid Evaluating Clinical Outcomes in Patients With Primary Biliary...
Liver CirrhosisBiliaryPrimary Biliary Cholangitis (PBC) is a serious, life-threatening, bile acid related liver disease of unknown cause. Without treatment, it frequently progresses to liver fibrosis and eventual cirrhosis requiring liver transplantation or resulting in death. The investigational drug, Obeticholic Acid (OCA) is a modified bile acid and FXR agonist that is derived from the primary human bile acid chenodeoxycholic acid. The key mechanisms of action of OCA, including its choleretic, anti-inflammatory, and anti-fibrotic properties, underlie its hepatoprotective effects and result in attenuation of injury and improved liver function in a cholestatic liver disease such as PBC. The study will assess the effect of OCA compared to placebo, combined with stable standard care, on clinical outcomes in PBC participants.
The Patency Period of the New Plastic Anti-reflux Biliary Stent
PancreatitisCholangitisThe aim of this study is to determine the average patency period of the new anti-reflux biliary stent on patients with malignant bile duct strictures and to determine if this stent remains patent for a longer period of time comparing with the ordinary plastic Tannenbaum biliary stent.
Thalidomide for the Treatment of Primary Sclerosing Cholangitis (PSC)
Primary Sclerosing CholangitisThe purpose of this study is to determine the safety and benefit of Thalidomide with primary sclerosing cholangitis (PSC). This is a six month study.
Non-comparative Study of BCD-085 in Combination With UDCA in Patients With Primary Biliary Cholangitis...
Liver CirrhosisBiliaryBCD-085 is an innovative drug, anti-interleukin-17 monoclonal antibody. The aim of the study is to evaluate the efficacy and safety of BCD-085 in patients with primary biliary cholangitis (PBC).
EXerCise Intervention in cholesTatic LivEr Disease: The EXCITED Study
Primary Biliary CholangitisA prospective, single centre, single-arm, pilot study investigating the safety and efficacy of a 12-week remotely-monitored home-based exercise program in patients with refractory fatigue (based on PBC-40 Quality of Life measure) secondary to Primary Biliary Cirrhosis.
Safety and Tolerability of Cilofexor in Participants With Primary Sclerosing Cholangitis (PSC) and...
Primary Sclerosing CholangitisCompensated CirrhosisThe primary objective of this study is to assess the safety and tolerability of escalating doses of cilofexor (CILO) in participants with primary sclerosing cholangitis (PSC) and compensated cirrhosis.