Study of INT 747 in Combination With URSO in Patients With Primay Biliary Cirrhosis (PBC)
Liver CirrhosisBiliaryThe primary hypothesis is that INT-747 will cause a reduction in alkaline phosphatase levels in Primary Biliary Cirrhosis patients, over a 12 week treatment period, as compared to placebo.
Pilot Study of Budesonide for Patients With Primary Sclerosing Cholangitis
CholangitisSclerosing2 moreOBJECTIVES: I. Assess the safety and effectiveness of budesonide in patients with primary sclerosing cholangitis or primary biliary cirrhosis experiencing a suboptimal response to ursodeoxycholic acid. II. Estimate the efficacy of this therapy in these patient groups as a means of evaluating the feasibility of a long-term randomized trial.
A 5-year Longitudinal Observational Study of Patients With Primary Biliary Cholangitis
Biliary CirrhosisPrimaryThis is a 5-year, longitudinal, observational study of patients with PBC designed to specifically address important clinical questions that remain incompletely answered from registration trials. In addition to the study database, a bio specimen repository will also be included so that translational studies of genomics and biomarkers of response may be performed.
Genetic Epidemiology of Primary Biliary Cirrhosis (PBC)
Primary Biliary CirrhosisPrimary Biliary Cirrhosis (PBC) is a progressive liver disorder of unknown cause. Current evidence suggests that genes, the genetic material we inherit from our parents, in combination with environmental factors, likely play an important role in the development of PBC. This study is being done to investigate whether genes make people more likely to develop PBC. Discovery of these proposed genes will help us better understand how PBC developes, and subsequently, to apply new approaches for its prevention, diagnosis and treatment.
An Open Label, Single-dose, Single Period ADME Study of A4250 in Healthy Subjects
Orphan Cholestatic Liver DiseasesProgressive Familial Intrahepatic Cholestasis2 moreThe primary objectives of the study are to assess the mass balance recovery after a single dose of carbon-14 [14C]-A4250 as a capsule and to provide plasma, urine and faecal samples for metabolite profiling and structural identification in healthy male subjects.
Primary Biliary Cirrhosis: Investigating A New Treatment Option Using NI-0801, an Anti-CXCL10 Monoclonal...
Primary Biliary CirrhosisThe purpose of the study is to assess safety and efficacy of multiple doses of NI-0801 in primary biliary cirrhosis patients with an inadequate response to ursodeoxycholic acid.
Fenofibrate in Combination With Ursodeoxycholic Acid (UDCA) in Primary Biliary Cirrhosis
Primary Biliary CirrhosisThe purpose of this study is to determine if the combination of ursodeoxycholic acid (UDCA) and fenofibrate is more effective than UDCA alone in the treatment of primary biliary cirrhosis.
An Open-label Study to Evaluate the Long-term Safety and Tolerability of LUM001 in Patients With...
Primary Biliary CirrhosisOpen-label, multicenter study in adults with Primary Biliary Cirrhosis (PBC) designed to evaluate the long-term safety and tolerability of daily dosing with LUM001.
Genomic Resources for Enhancing Available Therapies (GREAT1.0) Study
Chronic PancreatitisInflammatory Bowel Diseases25 moreThis is a prospective, descriptive, observational research study designed to observe and document the clinical practice by domain experts, and how the knowledge of new findings that are published in the medical literature affect clinical decision making. The study will evaluate risk factors and co-variants, including genetic variants that are associated with disease progression such as pain, inflammation, organ dysfunction, disability and quality of life.
Oral Budesonide in the Treatment of Patients With Primary Biliary Cirrhosis and Overlap Features...
Primary Biliary CirrhosisAutoimmune HepatitisThe purpose of the study is to find out the effects Budesonide, 9 mg daily for one year, has on patients with Primary Biliary Cirrhosis with features of autoimmune hepatitis.