26 results
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.
The main objective of this study is to determine whether lowering estrogen and progesterone levels with leuprorelin decreases liver growth rates in pre-menopausal women with severe PLD.Secondary objectives are to assess in these women the effect of…
The primary objective of the study is to assess the proportion of neonates with hyperbilirubinaemia necessitating treatment that is detected using universal TcB screening compared to using only visual inspection, while decreasing the number of heel…
Primary objective • In this study we will investigate whether biochemical imaging of change (Δ, figure 1) in the metabolic phospholipid ratios of PME and PDE between baseline and after 2 weeks of therapy are predictive for progression free survival…
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…
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…
Primary objectivesThis Phase 3 study is conducted to evaluate lanifibranor in adults with NASH and liver fibrosis and consists of 2 sequential periods - an initial double-blind placebo-controlled period of minimum 72 weeks followed by a double-blind…
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:…
Primary objective:1. To determine the association between insulin-stimulated hepatic glucose uptake rate measured by dynamic [18F]-FDG PET and hepatic fat content in overweight/obese subjects. Exploratory objectives:1. To compare insulin-stimulated…
To compare the median time-to-symptom-onset in patients with an internal external PTBD catheter without daily flushing compared to median time-to-symptom-onset in patients with an internal external PTBD catheter who daily flush the catheter.Symptoms…
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…
Primairy objective:To determine the effect of a 4-week high SFA diet compared to a 4-week high fructose diet on hepatic insulin sensitivity (determined by insulin-stimulated suppression of endogenous glucose production).Secondary objectives: - To…
The primary objective of this observational study is:- to determine if patients with Chronic Liver Disease (CLD) mount comparable humoral immune responses to healthy controls at 8-months following SARS-CoV-2 vaccination.Secondary objectives of this…
To investigate:- Whether a harm reduction strategy with education and counseling is effective in reducing the use of AAS by amateur athletes. - The harm reduction potential of an additional online consultation with a well-known fitness expert. -…
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…
The primary objective of this cohort study is to determine the prevalence of simple and progressed NAFLD in subjects at risk followed by the general practitioner The secondary objectives are:1. To study the factors linked to the development of NAFLD…
Primary:• To evaluate the long-term safety and tolerability of seladelparSecondary:• To evaluate the long-term efficacy of seladelpar• To evaluate the effect of seladelpar on patient-reported outcomes (pruritus)Exploratory• To evaluate the effect of…
The primary aim of this study is to assess the correlation between the plasma tacrolimus concentration and the whole blood tacrolimus concentration during pregnancy in kidney and liver transplant recipients. Secondary aims are the differences in…
Are the elevated levels of oxylipins seen in itching cholestatic patients responsible for typical itch by activating TRPA1?
In this study we will investigate how quickly and to what extend the approved compounds repaglinide, tolbutamide, midazolam or caffeine are absorbed and eliminated from the body when it is given together with PXL770. This study is a drug-drug…