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Saroglitazar Magnesium for Treatment of Primary Biliary Cholangitis
Jacksonville, FL; Rochester, MN
The purpose of this study is to to evaluate the effectiveness and safety of Saroglitazar Magnesium’s optimal dose (1 or 2 mg) and placebo in subjects with primary biliary cholangitis (PBC).
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A Study of Modafinil for the Treatment of Fatigue in Patients with Primary Biliary Cirrhosis
Rochester, MN
The purpose of this study is to evaluate the safety and effectiveness of modafinil for the treatment of fatigue in patients who have Primary Biliary Cirrhosis.
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Study to Evaluate the Safety, Tolerability, PDs, and Efficacy of CNP-104 in Subjects With Primary Biliary Cholangitis
Jacksonville, FL
The purpose of this study is to assess the safety and tolerability of CNP-104, and to assess the change in Serum Alkaline Phosphatase (ALP) levels among patients treated with CNP-104 or placebo.
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A Study of Improving Liver Ultrasound Effectiveness for Fibrosis Staging
Rochester, MN
The purpose of this study is to assess the effectiveness of a new ultrasound technique for non-invasive evaluation of liver fibrosis.
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A Study of Seladelpar in Subjects with Primary Biliary Cholangitis (PBC) and an Inadequate Response to or an Intolerance to Ursodeoxycholic Acid (UDCA)
Scottsdale/Phoenix, AZ
The purpose of this study is to evaluate the safety and effectiveness of seladelpar in subjects with primary biliary cholangitis (PBC) and an inadequate response to or intolerance to ursodeoxycholic acid (UDCA)
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A Study to Evaluate Efficacy and Safety of an Investigational Drug Named Volixibat in Patients With Itching Caused by Primary Biliary Cholangitis
Rochester, MN
The purpose of this study is investigating the safety and effectiveness of Volixibat in the treatment of cholestatic pruritis.
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Dose Response Study of GSK2330672 for the Treatment of Pruritus in Patients With Primary Biliary Cholangitis
Scottsdale/Phoenix, AZ
This study is being conducted to evaluate the efficacy, safety and tolerability of GSK2330672 administration for the treatment of pruritus (itch) in participants with primary biliary cholangitis (PBC). Participants will be treated with either placebo or one of the 4 dose regimens of GSK2330672 (20 milligram [mg], 90 mg or 180 mg taken once daily or 90 mg twice daily). Subjects on GSK2330672 will also receive placebo tablets to maintain blinding. The total duration of a subject's participation will be up to 45 days of screening and 24 weeks of study including follow-up.
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Biobank for Cholestatic Liver Diseases
Rochester, MN
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).
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Dissecting the Genetic Environment Contributions of Autoimmune Liver Disease
Rochester, MN
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).
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Prospective Tissue Collection of Hepatic Epithelia:
Rochester, MN
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).
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A Study to Evaluate Diagnostic Accuracy of the Controlled Attenuation Parameter(CAP) Measured by FibroScan® in Patients Scheduled for a Liver Biopsy
Rochester, MN
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.
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Single and Multiple Dose Escalation of PHIN-214 in Child-Pugh A and B Liver Cirrhotics
Rochester, MN
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.
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A Study to Develop a Resource (bank) of Biospecimens and Data Collected from Individuals with Liver Disease and Without Liver Disease
Rochester, MN
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.