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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…

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.…

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 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:…

Efficacy of the combination of simvastatin plus rifaximin in patients with decompensated cirrhosis to prevent ACLF development: a multicenter, double-blind, placebo controlled randomized clinical trial.

The aim of this study is to assess the efficacy of oral administration of simvastatin plus rifaximin in patients with decompensated cirrhosis to halt the progression of the disease as assessed by prevention of the development of ACLF.

A randomised, double-blind, placebo-controlled, multicentre, Phase 3 study evaluating efficacy and safety of lanifibranor followed by an active treatment extension in adult patients with non-cirrhotic non-alcoholic steatohepatitis (NASH) and fibrosis 2 (F2)/fibrosis 3 (F3) stage of liver fibrosis

This study has been transitioned to CTIS with ID 2023-508248-23-00 check the CTIS register for the current data. Primary objectivesThis Phase 3 study is conducted to evaluate lanifibranor in adults with NASH and liver fibrosis and consists of 2…

The effect of semaglutide in non-cirrhotic non-alcoholic steatohepatitis

This study has been transitioned to CTIS with ID 2023-506962-30-00 check the CTIS register for the current data. Primary objectivesThe trial has two parts, a part 1 and a part 2, with distinctive objectives and endpoints.Part 1 of the trial: To…

Double-blind, randomized, placebo-controlled, phase III study comparing norursodeoxycholic acid capsules with placebo in the treatment of primary sclerosing cholangitis

This study has been transitioned to CTIS with ID 2023-510200-42-00 check the CTIS register for the current data. Primary:• To show the superiority of norursodeoxycholic acid (norUDCA) compared to placebo in the treatment of Primary Sclerosing…

A Double-Blind, Randomized, Placebo-Controlled, Phase 3 Study to Demonstrate Efficacy and Safety of A4250 in Children with Progressive Familial Intrahepatic Cholestasis Types 1 and 2 (PEDFIC 1)

To demonstrate the efficacy of repeated daily doses of 40 µg/kg/day and 120 µg/kg/day A4250 in children with progressive familial intrahepatic cholestasis (PFIC) Types 1 and 2, as determined by the following:* Proportion of patients experiencing at…

A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study
Evaluating the Safety and Efficacy of Selonsertib in Subjects with
Nonalcoholic Steatohepatitis (NASH) and Bridging (F3) Fibrosis

The primary objective of this study is:-To evaluate whether selonsertib (SEL, previously known as GS- 4997) can cause fibrosis regression and reduce progression tocirrhosis and associated complications in subjects with NASH and bridging (F3)…

A Phase 3, Double Blind, Placebo Controlled Trial and Long Term Safety Extension of Obeticholic Acid in Patients with Primary Biliary Cirrhosis

Main Objective: To assess the effects of OCA in patients with PBC on: -Serum alkaline phosphatase (ALP) and total bilirubin, together as a composite endpoint -SafetySecondary Objectives:To assess the effects of OCA in patients with PBC on:-…