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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…

Evaluation of the safety, effectiveness and natural care approach of the Jauni phototherapy romper.

We will assess safety (potential adverse events related to phototherapy using Jauni, e.g. skin injuries, hyperthermia, or hypothermia) and effectiveness (e.g. rate of lowering of bilirubin levels, duration of phototherapy need) of phototherapy using…

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…

Per-Oral Cholangioscopy (POCS) in Liver Transplantation Patients

• To demonstrate the clinical utility of POCS in cadaveric donor or live donor liver transplantation patients referred for endoscopic retrograde cholangiopancreatography (ERCP) in the setting of a clinical suspicion of post-liver transplant bile…

Long-term hepatotoxicity of azathioprine, 6-mercaptopurine and 6-thioguanine in IBD patients

Assess hepatotoxicity of long-term azathioprine and 6-mercaptopurine use in IBD-patients as compared with a cohort of long-term 6TG users

A PHASE I, SPONSOR-OPEN, INVESTIGATORBLINDED,SUBJECT-BLINDED, MULTI-CENTER,
PLACEBO-CONTROLLED STUDY TO EVALUATE SAFETY, TOLERABILITY, PHARMACOKINETICS
AND PHARMACODYNAMICS OF ORAL ADMINISTRATION OF RO7020531: (1). SINGLE
AND MULTIPLE ASCENDING DOSES IN HEALTHY MALE AND FEMALE SUBJECTS; (2). 6-WEEK
TREATMENT OF VIROLOGICALLY SUPPRESSED PATIENTS WITH CHRONIC HEPATITIS B VIRUS
INFECTION

OBJECTIVESPrimary ObjectivesThe primary objective is:* To assess the safety and tolerability of 6 weeks of treatment with RO7020531 administered orally to virologically suppressed chronic hepatitis B (CHB) patients.Secondary ObjectivesThe secondary…

A Phase 4, Double-Blind, Randomized, Placebo-Controlled, Multicenter Study Evaluating the Effect of Obeticholic Acid on Clinical Outcomes in Subjects with Primary Biliary Cholangitis

To evaluate the effect of Obeticholic Acid on clinical outcomes in subjects with primary biliary cholangitis

Intraprocedural assessment of Ablation Margins using COMPuted tomography co-registration in primary LivEr Tumor treatment with percutanEous ablation: IAMCOMPLETE primary

To investigate the feasibility of co-registration with MIRADA XD of pre- and post-ablation CT using an optimized scanning protocol. Secondary objectives will be to investigate the reproducibility of CT-CT co-registration, to determine the duration…

Effect of 4 weeks of oral D. piger on safety, pharmacokinetics and ethanol metabolism in overweight individuals (2023)

To assses safety, gut engraftment and effects on sugar- and alcohol metabolism of d. piger in individuals with increased waist circumference.

A three-part, phase 1, randomized, controlled, dose-escalation study of INT-787 following single or multiple dose administration in healthy subjects.

In this study we will investigate how safe the new compound INT-787 is and how well it is tolerated when it is used by healthy participants.We also investigate how quickly and to what extent multiple doses of INT-787 are absorbed, transported,…

Liver transplantation in patients with CirrHosis and severe Acute-on-Chronic Liver Failure (ACLF): iNdications and outComEs (CHANCE)

1. Primary objective: Survival results of LT in patients with severe ACLF To compare 1-year graft and patient survival rates after LT in patients with ACLF-2 or 3 at the time of LT with patients with decompensated cirrhosis without ACLF 2-3 and…

The Clock thickens:
Morning or evening training for the treatment of NAFLD?

The aim of the study is to identify the effect of exercise timing on NAFLD. Additionally, we aim to increase the understanding of the exercise-related modulation of the metabolic and inflammatory processes causing NAFLD, including insulin resistance…

A Randomized, Double-blind, Placebo-controlled, Parallel-group, Multiple-dose Phase 2 Study
to Evaluate the Efficacy and Safety of BMS-986263 in Adults with Compensated Cirrhosis from
Nonalcoholic Steatohepatitis (NASH)

Primary objectiveTo evaluate the efficacy of BMS-986263 compared with placebo to improve liver fibrosis in participants with compensated cirrhosis due to NASHSecondary objectives1. To further assess the efficacy of BMS-986263 compared with placebo…

Randomised, double-blind, placebo-controlled and parallel group
trial to investigate the effects of two doses (up-titration to a fixed
dose regimen) of oral BI 685509 on portal hypertension after 24
weeks treatment in patients with clinically significant portal
hypertension (CSPH) in compensated cirrhosis

The trial will compare two doses of BI 685509 (2 mg and 3 mg BID) with placebo, on top of standard of care, in patients with CSPH in compensated alcohol-related cirrhosis. The primary objective is to estimate the mean difference between treatment…

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…

Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Effects of EP547 in Subjects with Cholestatic Pruritus Due to Primary Biliary Cholangitis or Primary Sclerosing Cholangitis

Primary objective* To assess the efficacy of EP547 compared to placebo on pruritus as assessed by the Worst Itch Numeric Rating Scale (WI-NRS)Secondary* To assess the efficacy of EP547 compared to placebo on the following:* Pruritus-related quality…

A placebo-controlled, proof-of-concept study to evaluate the safety and efficacy of Lanifibranor alone and in combination with the sodium-glucose transport protein 2 (SGLT2) inhibitor EmpaGliflozin in patiEnts with Nonalcoholic steatohepatitis (NASH) and type 2 Diabetes mellitus (T2DM)

1. Primary Objective The primary objective of this study is to assess the effect of lanifibranor alone compared toplacebo and the effect of lanifibranor in combination with empagliflozin compared to placeboon HbA1c after a 24-week treatment duration…

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…

ASSURE: An Open Label Long-Term Study to Evaluate the Safety and Tolerability of Seladelpar in Subjects with Primary Biliary Cholangitis (PBC)

This study has been transitioned to CTIS with ID 2024-511753-22-00 check the CTIS register for the current data. Primary:• To evaluate the long-term safety and tolerability of seladelparSecondary:• To evaluate the long-term efficacy of seladelpar•…

Assessment of Treatment with Laparoscopic fenestration or Aspiration Sclerotherapy for large symptomatic hepatic cysts (ATLAS): a randomized clinical trial.

The main objective is to compare laparoscopic fenestration and aspiration sclerotherapy in patients with large symptomatic hepatic cysts on patient-reported outcomes. This information can be used to assess cost-effectiveness in both treatments.