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A 12-week randomized, patient and investigator blinded, placebo-controlled, parallel group study to investigate the efficacy of LIK066 in obese patients with non-alcoholic steatohepatitis (NASH)

Primary objective:- To determine the effect of LIK066 on Liver Function test after 12 weeks of treatmentSecondary objectives: - To determine the effect of LIK066 on intrahepatic lipid after 12 weeks of treatment- To determine the effect of LIK066 on…

A randomized, double blind, placebo-controlled, multicenter phase III study of regorafenib in patients with hepatocellular carcinoma (HCC) after sorafenib

The objective of this study is to evaluate efficacy and safety of regorafenib in patients with HCC who have progressed after sorafenib.

A Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of ABT-450/Ritonavir/ABT-267 (ABT-450/r/ABT-267) and ABT-333 Co-administered with Ribavirin (RBV) in
Treatment-Experienced Adults with Genotype 1 Chronic Hepatitis C Virus (HCV) Infection (SAPPHIRE-II)

The primary objectives of this study are to compare the percentage of subjects achieving SVR12 (HCV RNA < lower limit of quantification [LLOQ] 12 weeks following treatment) of 12 weeks of treatment with ABT-450/r/ABT-267 and ABT-333 co-…

A Phase III, Randomised, Partially Double-Blind and Placebo-Controlled Study of BI 207127 in Combination with Faldaprevir and Ribavirin in Treatment-Naïve Patients with Chronic Genotype 1 HCV Infection

The aim of the study is to confirm efficacy and safety of treatment with 600 mg of BID BI207127 in combination with 120 mg QD Faldaprevir and RBV for 16 and 24 weeks in target chronically infected HCV GT1b treatment naïve patients, including a…

A randomized double blind placebo controlled study on the effects of fenretinide Lym-X-Sorb on insulin sensitivity in obese insulin resistant subjects

Primary objective:To assess the effects of fenretinide on hepatic and peripheral insulin sensitivity in obese, insulin resistant subjectsSecondary objective:To assess the effects of fenretinide on hepatic steatosis, body weight and body fat…

A Study of INT-747 (6-ECDCA) in Combination with Ursodeoxycholic Acid (URSO®, UDCA) in Patients with Primary Biliary Cirrhosis

In patients with primary biliary cirrhosis (PBC) taking UDCA, to assess the effects of INT-747 on: Primary: - Alkaline phosphatase (AP) levels - SafetySecondary: - Hepatocellular injury and liver function - Disease-specific and general health…

COPE-trial: Colesevelam versus placebo in cholestatic pruritus, a double-blind placebo-controlled study

Pruritus is a frequent and debilitating symptom in patients with Primary Biliary Cirrhosis, Primary Sclerosing Cholangitis and other cholestatic liver diseases. Aim is to assess the effect of Colesevelam on cholestatic pruritus.

A randomized, double-blind, placebo-controlled, Phase III trial of 2 regimens of telaprevir (with and without delayed start) combined with pegylated interferon alfa-2a (Pegasys®) and ribavirin (Copegus®) in subjects with chronic genotype 1 hepatitis C infection who failed prior pegylated interferon plus ribavirin treatment.

The primary objective is to demonstrate the superior efficacy of telaprevir in combination withPeg-IFN alfa-2a and RBV compared to standard treatment in subjects with chronic HCVgenotype 1 infection who failed prior treatment with Peg-IFN plus RBV.…

Long-acting lanreotide as a volume reducing treatment of polycystic livers

efficacy of lanreotide LAR in controling total liver volume in patients with hepatic cysts as a result of ADPKD or PCLD

Double-blind, randomised, placebo-controlled, multi-centre phase III clinical study comparing the combination of ursodeoxycholic acid capsules plus budesonide capsules to ursodeoxycholic acid capsules plus placebo in the treatment of primary biliary cirrhosis

To compare the efficacy and tolerability of a combination therapy with ursodeoxycholic acid (12-16 mg/kg body weight plus budesonide (9mg/d) vs. ursodeoxycholic acid (12-16 mg/kg BW/d) plus placebo in the treatment of PBC. To study safety and…

A randomized double-blind, placebo-controlled, single and multiple ascending dose study to evaluate the safety and pharmacokinetics of OCR 002 in healthy volunteers.

SADTo evaluate the safety and tolerability of ascending single doses (SAD) of OCR 002 administered as intravenous (IV) infusions in healthy volunteersTo evaluate the plasma pharmacokinetics (PK) of phenylacetate and ornithine and glutamine after a…

A phase 1, randomized, double-blind, placebo-controlled, ascending dose study evaluating the safety, tolerability and pharmacokinetics of JTK-652 administered for two weeks in healthy male subjects

Primary objectives : to investigate the safety and tolerability of multiple oral doses of JTK-652 administered for 14 days to healthy male subjectsSecondary objectives : tot determine the pharmacokinetics of multiple oral doses of JTK-652…

The effect of peroxisome proliferator activator receptor * agonist pre-treatment on pegylated interferon-*2a and ribavirin efficacy in hepatitis C patients, previously resistant to treatment with pegylated interferon and ribavirin
- a randomized-controlled trial -

The primary objective is to study the effect of a 16-week treatment with a PPAR-* agonist versus placebo on effectiveness of subsequent standard treatment with PEG-IFN and RBV, measured as SVR, in previously non-responders or relapsers with CHC…

Effects of a butyrate enema on systemic concentrations of short chain fatty acids

In the present study the effects of the colonic administration of butyrate on portal, hepatic, mesenteric venous and arterial SCFA concentrations will be studied in patients undergoing major upper abdominal surgery. The aim is to clarify the…

A blinded, randomized, placebo-controlled trial in genotype 1 hepatitis C-infected subjects to evaluate the efficacy, safety, tolerability and pharmacokinetics of repeated doses of TMC435350, with or without peginterferon alpha-2a and ribavirin.

The primary objectives of this trial are the following:- to determine the dose dependency of the antiviral effect of TMC435350 during 1 week ofmonotherapy in treatment-naïve HCV-infected subjects;- to determine the dose dependency of the antiviral…

The effect of bezafibrate on cholestatic itch

To evaluate the effect of bezafibrate in cholestatic pruritus.

A phase 1, randomized, double-blind, placebo-controlled, escalating single- and multiple-dose study to evaluate the safety, tolerability and pharmacokinetics of EYP001a in healthy male subjects.

In Part 1, a single dose of EYP001a or placebo (same formulation but without the active ingredient EYP001a) will be administered and a total of 6 dose levels of EYP001a will be investigated. The purpose of Part 1 is to investigate how safe EYP001a…

A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study
Evaluating the Safety and Efficacy of Selonsertib in Subjects with
Compensated Cirrhosis due to Nonalcoholic Steatohepatitis (NASH)

The primary objective of this study is:• To evaluate whether selonsertib (SEL, previously known as GS 4997) can cause fibrosis regression and reduce associated complications in subjects with cirrhosis due to NASH. The secondary objective of this…

RESPONSE: A Placebo-controlled, Randomized, Phase 3 Study to Evaluate the Efficacy and Safety of Seladelpar in Patients With Primary Biliary Cholangitis (PBC) and an Inadequate Response to or an Intolerance to Ursodeoxycholic Acid (UDCA)

Primary Objective: • Efficacy: To evaluate the treatment effect of seladelpar on composite biochemical improvement in cholestasis markers based on alkalinephosphatase (ALP) and total bilirubin at 12 months of treatment compared to placebo• Safety:…

Multicenter, double-blind, parallel-group, randomised, 48 weeks, dose-ranging, placebo-controlled phase II trial to evaluate efficacy, safety and tolerability of multiple subcutaneous (s.c.) doses of BI 456906 in patients with non-alcoholic steatohepatitis (NASH) and fibrosis

The main trial objectives are to demonstrate a non-flat dose response curve, to evaluate the size of the treatment effect (using the absolute difference in proportions of patients with histological improvement between BI 456906 and placebo at week…