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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 PHASE 2, RANDOMIZED, DOUBLE BLIND, PLACEBO CONTROLLED, PARALLEL GROUP, MULTIPLE CENTER STUDY TO EVALUATE THE SAFETY, TOLERABILITY, AND EFFICACY OF NGM282 ADMINISTERED FOR 12 WEEKS IN PATIENTS WITH PRIMARY SCLEROSING CHOLANGITIS (PSC)

Primary Objective: • Evaluate the treatment effect of NGM282 as measured by the mean change in alkaline phosphatase (ALP) from Baseline to Week 12 in patients with PSC.Secondary Objectives:• Assess the safety and tolerability of NGM282 in patients…

A Phase 2b, Dose-Ranging, Randomized, Double-Blind, Placebo-Controlled Trial
Evaluating the Safety and Efficacy of GS-6624, a Monoclonal Antibody Against Lysyl
Oxidase Like 2 (LOXL2) in Subjects with Primary Sclerosing Cholangitis (PSC)

The primary objective of this study is:• To evaluate whether simtuzumab (formally referred to as GS-6624) is effective at preventing the progression of liver fibrosis in subjects with PSC.The secondary objectives of this study include the following…

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…

Dose-Ranging Study to Evaluate the Safety, Efficacy and Pharmacokinetics of Pegylated Interferon Lambda (BMS-914143) Monotherapy in Interferon-Naive Patients with Chronic Hepatitis B Virus Infection who are HBeAg-positive

Primary objectives:• To evaluate the safety and tolerability of BMS-914143 as measured by the frequency of SAEs and discontinuations due to AEs;• To assess the HBeAg seroconversion rate at 24 weeks off treatment (Week 72).Secondary objective• To…

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…

Everolimus added to long acting octreotide as a volume reducing treatment of polycystic livers.

Reduction of polycystic liver volume by treating with octreotide, whether or not combined with everolimus. Assessing whether combination therapy of everolimus and octreotide gives a bigger reduction of polycystic liver volume than octreotide…

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…

A Phase IIa randomized, open-label study of telaprevir (VX-950) administered every 12 or every 8 hours in combination with either Peg-IFN alfa2a (Pegasys®) and ribavirin (Copegus®) or Peg-IFN alfa2b (PegIntron®) and ribavirin (Rebetol®) in treatment naive subjects with chronic genotype 1 hepatitis C infection.

The objective of this trial is to explore the efficacy, safety, tolerability, pharmacokinetics, and pharmacokinetic-pharmacodynamic relationships of telaprevir when administered as 750 mg q8h or 1125 mg q12h in combination with Peg IFN alfa2a (…

The effect of bezafibrate on cholestatic itch

To evaluate the effect of bezafibrate in cholestatic pruritus.

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…

A Two Part Phase IIa/b Multicentre, Randomised, Double-Blind,
Placebo-Controlled, Parallel Group Dose-ranging Study to Assess
Efficacy, Safety, and Tolerability of the Combination of
Zibotentan and Dapagliflozin, and Dapagliflozin Monotherapy
Versus Placebo in Participants with Cirrhosis with Features of
Portal Hypertension

This study has been transitioned to CTIS with ID 2023-505405-17-00 check the CTIS register for the current data. The main objective of this Phase IIa/b study is to demonstrate the effectof zibotentan on HVPG, and that dapagliflozin can mitigate…

Synbiotics and Conditioned Fecal Microbiota Transplantation to Treat Non-Alcoholic Steatohepatitis.

Primary objective To investigate the therapeutic potential of A. soehngenii and pasteurized A. muciniphila combined with B. animalis subsp. lactis and FOS with and without conditioned vegan LFMT capsules to reduce NASH in patients with fibrotic NASH…

A GnRH Agonist IN pre-menopausal women STudy to treat severe Polycystic Liver Disease

This study has been transitioned to CTIS with ID 2023-506637-30-00 check the CTIS register for the current data. The main objective of this study is to determine whether lowering estrogen and progesterone levels with leuprorelin decreases liver…

Randomized, placebo-controlled, double blind, multi-centre Phase IIb study to evaluate the efficacy and safety of HepaStem in patients with acute on chronic liver failure (ACLF).

The primary objective is:to demonstrate the efficacy of 2 infusions (intravenous [i.v.]) of HepaStem at 1.0 million of cells/kg body weight (BW) (7 days apart) on the overall survival proportion at 90 days post first infusion.The secondary…

A Placebo-Controlled, Multi-dose, Phase 2 Study to Determine the Safety, Tolerability and Pharmacodynamic Effect of ARO-AAT in Patients with Alpha-1 Antitrypsin Deficiency (AATD) (SEQUOIA)

Primary Objective:• To select a single dose for use in later stage development based on a combined evaluation of safety and pharmacodynamic effects of ARO-AAT

A Phase 2, Randomized, Double-blind, Placebo-controlled Study Investigating Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Two Dose Levels of Belcesiran in Patients with Alpha-1 Antitrypsin Deficiency-Associated Liver Disease

Primary objectives:Cohort 1 and 21. To evaluate the safety and tolerability of multiple doses of belcesiran in patients with AATLD2. To characterize the pharmacodynamics of belcesiran in patients with AATLDCohort 3 1. To characterize the…

Double-blind, randomised, placebo-controlled, phase IIb trial on the efficacy and safety of norursodeoxycholic acid tablets in patients with non-alcoholic steatohepatitis (NASH)

Primary objective:* To evaluate the efficacy of norursodeoxycholic acid (norUDCA) 1500 mg vs. norUDCA 1000 mg vs. placebo for the treatment of NASHSecondary objectiveTo study safety and tolerability (adverse events [AEs], laboratory parameters) of…

A 12-month, open-label, multicenter, randomized, safety, efficacy, pharmacokinetic (PK) and pharmacodynamic (PD) study of two regimens of anti-CD40 monoclonal antibody, CFZ533 vs. standard of care control, in adult de novo liver transplant recipients with a 12-month additional follow-up and a long-term extension (CONTRAIL I).

This study will allow the assessment of the ability of CFZ533 to replace calcineurin inhibitors (CNIs) in terms of anti-rejection efficacy, while providing potentially better renal function with an expected similar safety and tolerability profile.…

Double-blind, randomized, placebo-controlled, phase II dose-finding study comparing different
doses of Rhudex granules with placebo in the treatment of primary biliary cholangitis

Primary:To evaluate the efficacy of 3 doses of RhuDex vs placebo for the treatment of PBC in patients with an inadequate response to UDCA.Secondary:• To identify efficacious RhuDex dose(s) for the treatment of PBC for further evaluation in phase III…