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The Role of the Intestinal Barrier Function in Liver Cirrhosis

Understanding the pathophysiological mechanisms that play a role in liver cirrhosis and its complications. For that aim, we want to study the functional and morphological intestinal epithelial barrier and microbiota of both small and large intestine…

THE EFFECTS OF RECOMBINANT HUMAN INSULIN-LIKE GROWTH FACTOR-1 ON THE NUTRITIONAL STATUS IN PATIENTS WITH LIVER CIRRHOSIS: A PILOT STUDY.

The primary objective of this pilot study is to evaluate the effects of 6 months of recombinant human IGF-I (rhIGF-I) treatment on the body composition.The secondary objective is to assess the effects of the treatment on the liver function,…

A Phase 2, Multicenter, Open-Label Study to Investigate the Safety and Efficacy of Sofosbuvir/Ledipasvir Fixed-Dose Combination + Ribavirin Administered in Subjects Infected with Chronic HCV who have Advanced Liver Disease or are Post-Liver Transplant

The primary objectives of this study are:•To explore the antiviral efficacy of combination therapy with SOF/LDV FDC + RBV for12 or 24 weeks in subjects with advanced liver disease (either pre-liver transplant or notcurrently wait-listed) and post-…

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…

The use of perioperative antibiotic prophylaxis in the treatment of acute cholecystitis, a randomized, multicenter, non-inferiority trial

To provide high level of evidence that omitting perioperative antibiotic prophylaxis does not increase the postoperative infection rate, in patients with acute calculous cholecystitis undergoing laparoscopic cholecystectomy.

Liver Fibrosis in a Home Parenteral Nutrition Cohort

main objective: Investigate the prevalence of liver fibrosis according to TE values in children enrolled in a HPN-program. Secondary objectives: Investigate the correlation between TE values and ELF test score and APRI in children enrolled in a HPN-…

Population pharmacokinetics and pharmacodynamics of sorafenib in hepatocellular carcinoma patients with Child Pugh B liver cirrhosis

1. To optimize sorafenib treatment in patients with HCC and CP-B liver cirrhosis by exploration of sorafenib exposure, its variability and predictive factors .Secondary:2. To assess the relation between sorafenib exposure and both toxicity and…

A feasibility study comparing two strategies of oral contrast in patients undergoing contrast-enhanced abdominal CT: 50 ml Télébrix Gastro + 950 ml water vs 1000 ml water only.

The aim of this study is to compare the image quality, diagnostic confidence and patient discomfort when using either positive (50 ml Télébrix Gastro + 950 ml water ) or negative 1000 ml water only in outpatients undergoing a contrast-enhanced…

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…

Grazoprevir (MK-5172) + Elbasvir (MK-8742) for the treatment of ACUTE hepatitis C genotype 1/4. The Dutch Acute HCV in HIV Study (DAHHS-2)

The goal of this study is to document the efficacy of a shortened 8-week therapy with grazoprevir and elbasvir in patients with acute HCV genotype 1 or 4 infection.

Evaluation of the CAP-value for quantitating liver steatosis in obese children using 1H-MRS as reference standard

To investigate the correlation between the CAP-value measured with the FibroScan® device and liver fat percentage measured with 1H-MRS in a well-characterized cohort of obese children at risk of having fatty liver disease.

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…

Immune phenotyping in chronic HCV patients treated with Sofosbuvir and Daclatasvir combination for 12 or 24 weeks * SODA study

Primary objectiveThe primary objective for this study is to analyse the impact of inhibition of viral replication by interferon-free therapy consisting of Sofosbuvir and Daclatasvir (±Ribavirin) on the phenotype and function of the innate immune…

Immunogenetic and therapeutic aspects of Autoimmune Hepatitis

Primary Objective: To gain more insight in the genetic susceptibility for AIH. For this we will study the presence of candidate genes in AIH patients, study genetic similarities with other auto-immune diseases and perform a whole genome association…

Effect of Multiple healthy donor intestinal microbiota infusions on non Alcoholic Steatosis Hepatis (NASH) and vascular function in obese subjects

In this study we would like to investigate whether repetitive allogeneic (lean donor) fecal transplantations can reduce liversteatosis and if so which (small) intestinal bacteria cause this inflammation in the liver resulting in subsequent chronic…

Sedation with propofol TCI during ERCP: Is the combination with esketamine more effective and safer than with alfentanil (SPEKA): A randomized controlled multicentre trial

The aim of this study is to demonstrate that procedural sedation with propofol and esketamine is more effective and will result in less cardiopulmonary depression than sedation with propofol and the opioid alfentanil. Less side effects should also…

Scrutinizing (in)efficient use of cholecystectomy: a randomized trial concerning variation in practice.

Current practice variation in selection of patients with gallbladder stones and abdominal complaints for cholecystectomy is not efficient. Here we evaluate stepwise selection for surgery to improve patient outcome and to reduce the number of…

Acute biliary Pancreatits: early ERC plus sphincterotomy versus Conservative treatment: the APEC trial, a randomized, superiority, assessor-blinded multicenter trial.

The objective of the study is to investigate whether early ERC plus ES in patients with suspected APB and a predicted severe disease course without cholangitis, lowers the incidence of a composite endpoint of mortality and severe morbidity. Major…

An Open-label, Non-randomised, Multicentre, Comparative, Phase I Study to Determine the Pharmacokinetics, Safety and Tolerability of Olaparib Following a Single Oral 300 mg Dose to Patients with Advanced Solid Tumours and Normal Hepatic Function or Mild or Moderate Hepatic Impairment.

-The primary objective of this study is to investigate the pharmacokinetics (PK) of olaparib after a single oral dose of 300 mg to patients with advanced solid tumours and mild or moderate hepatic impairment compared to those with normal hepatic…

FGF19 in obstructive cholestasis: unveil the signal

To investigate FGF19 signalling and metabolic and functional consequences of a disturbed enterohepatic cycle in patients with obstructive cholestasis