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A phase 1, first-in-human, 2-part, randomized, double-blind, placebo
controlled, single ascending dose and sequential, open-label, multiple
ascending dose study to evaluate the safety, tolerability,
pharmacodynamics, and pharmacokinetics of VIS171 in healthy
participants and participants with autoimmune disease(s)

The purpose of this first-in-human (FIH) study is to assess the safety, tolerability, pharmacodynamics (PD), and pharmacokinetics (PK) of subcutaneous (SC) VIS171 in healthy participants (single ascending dose [SAD] - Part A) as well as in…

Pharmacokinetics of tacrolimus during pregnancy in kidney and liver transplant recipients.

The overall aim of the study is to gain more insight in as well as understand and map the pharmacokinetics of tacrolimus during pregnancy. Therefore, we will study tacrolimus concentrations in maternal whole blood (routine care) and via area under…

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 2 Dose Ranging, Randomized, Double Blind, Placebo-Controlled Study Evaluating the Safety, Tolerability, Pharmacokinetics and Efficacy of EDP-305 in Subjects with Primary Biliary Cholangitis (PBC) with or without an Inadequate Response to Ursodeoxycholic Acid (UDCA)

Primary Objective:* To evaluate the effect of EDP-305 on alkaline phosphatase (ALP) levels.Secondary Objective:* To evaluate the safety and tolerability of EDP-305* To evaluate the effect of EDP-305 on bilirubin levels* To evaluate the effects of…

Effects of obesity, non-alcoholic fatty liver disease and bariatric surgery on systemic cytochrome P450-mediated drug metabolism using a COCKTAIL approach.

Primary objectives: To examine the effects of: (I) RYGB surgery, (II) obesity and (III) liver fat on drug metabolism using a cocktail approach. Secondary objectives: To examine the effects of: (I) RYGB surgery, (II) obesity and (III) NAFLD, on…

Ablation with irreversible electroporation in patients with advanced perihilar cholangiocarcinoma - a multicenter phase I/II safety study

This study is primarily set up to investigate the safety and feasibility of IRE for the treatment of unresectable, locally advanced or nodal metastasized PHC. The efficacy of IRE will also be studied.

Tacrolimus versus mycophenolate for AutoImmune hepatitis patients with incompLete response On first line therapy: a Randomized trial

The aim of this study is to compare the effectiveness of TAC with MMF as a second line treatment for AIH. Proportion of patients with CR after 12 months of treatment will be the primary outcome parameter to determine effectivity.

A Phase 1 Study to Evaluate the Potential Drug-Drug Interaction between GS-4224 and Probe Inhibitors, Inducers and Substrates in Healthy Subjects

The purpose of this study is to investigate how quickly and to what extent GS-4224 is absorbed and eliminated from the body. We study this when the study compound is administered alone and together with compounds that influence the activity of a…

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 multi-centre, double-blind, parallel-group, randomised, placebo controlled phase II a study to investigate safety, tolerability, pharmacodynamics, and harmacokinetics of different doses of orally administered BI 1467335 during a 12-week treatment period compared to placebo in patients with clinical evidence of NASH.

The primary objective of this study is the proof of mechanism and support of dose finding, together with the safety evaluation in patients with clinical evidence of NASH. To gain further insight into clinical effects of AOC3 inhibition on NASH…

Investigation of efficacy and safety of three dose levels of subcutaneous semaglutide once daily versus placebo in subjects with non-alcoholic steatohepatitis.

Primary objective:To compare the effect of semaglutide subcutaneous (s.c.) once daily versus placebo on histological resolution of non-alcoholic steatohepatitis (NASH). Secondary efficacy objectivesTo investigate the dose-response relationship of…

Adoptive Transfer of T cell Receptor-engineered T cells to treat hepAtocellular Carcinoma recurrence after liver Transplantation: a preclinical feasibility study

To isolate and validate TCRs that exclusively recognize liver antigens presented by specific (*recipient*) HLA-molecules (LSARH) on the surface of tumor cells.

Health testing with all subjects who participated in any phase I clinical study and received at least one dose of HTL0018318/AGN-242071 to date.

Because the risk of liver abnormalities for subjects who previously took HTL0018318/AGN-242071 is unknown the sponsor has decided that it is prudent to offer this initial 6-month health testing programme while further investigation of the toxicity…

A Double-Blind, Placebo-Controlled, Cross-over Phase II Study to Evaluate the Effect of a 6-week Elafibranor (120mg) treatment administered once daily on hepatic lipid composition in subjects with Nonalcoholic Fatty Liver (NAFL).

Primary Objective * To evaluate the effect of a 6-week treatment with elafibranor versus placebo on hepatic lipid composition in subjects with a fatty liver.Secondary objectives * To evaluate the between treatment difference (elafibranor 120 mg/d vs…

A phase I, open-label, randomized, three-way cross-over study comparing bioavailability of two formulations and assessing the food effect on tablet formulation after PXL770 single oral dose in healthy subjects

The purpose of this study is compare a tablet formulation of PXL770 to the capsule formulation of PXL770. It will be investigated how quickly and to what extent PXL770 in each formulation is absorbed and eliminated from the body. To limit the…

Transjugular intrahepatic portosystemic shunt (TIPS): effect on pharmacokinetics

To assess the effect of TIPS on drug metabolism of different drugs, metabolized by different metabolic pathways in patients with an elective TIPS placement using a cocktail approach, and to assess the effect of TIPS on bile acid metabolism.

IXSI: Interventional X-ray and Scintigraphy Imaging of 99mTc-MAA during the radioembolisation pretreatment procedure

Primary objective: To establish the safety of acquiring 2D and 3D hybrid images using IXSI in an interventional setting. Secondary objectives: To evaluate dosimetry of SPECT/CBCT acquired by IXSI. To image the (hemo-)dynamic processes influencing…

A randomized, double-blind, dose-ranging, placebo-controlled, Phase 2a evaluation of the safety, tolerability, and pharmacokinetics of PLN-74809 in participants with primary sclerosing cholangitis (PSC) and suspected liver fibrosis (INTEGRIS-PSC)

To assess the safety and tolerability of PLN 74809 in participants with PSC and suspected liver fibrosis

A randomized, double-blind, placebo-controlled, safety, tolerability, pharmacokinetic, and pharmacodynamic study of MET409 after single and multiple ascending oral dose administration in healthy male subjects

This study will be performed in 124 healthy male volunteers. The study will be performed in 2 parts, Part A and Part B.Part A will be performed in 64 healthy male volunteers divided over 8 groups of 8 volunteers each.Part B will be performed in 60…

A phase 1, open-label, fixed-sequence, drug-drug interaction study between multiple oral doses of Inarigivir Soproxil and a single oral dose of midazolam in healthy subjects

The purpose of the study is to investigate the effect of inarigivir on the absorption, distribution and elimination of midazolam in order to assess to what extent inarigivir may possibly change the pharmacokinetics of other drugs when given with…