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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.

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 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…

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…

A multi-center randomized, open label, controlled study in primary liver transplantation comparing long term renal function in recipients treated with standard dose extended release tacrolimus alone and recipients treated with a combination of low dose extended-release tacrolimus and low dose sirolimus.

To evaluate the effectiveness and safety of concentration controlled combination of once daily dosed low-dose sirolimus (trough levels: 3-5 ng/ml) and extended-release tacrolimus (trough levels:3-5 ng/ml), in order to provide superior renal function…

Effect of total parenteral feeding on the postprandial bile acid response

In this study, we aim to investigate the difference in the anabolic postprandial bile acid response between an enteral and parenteral mixed meal test (MMT) in healthy lean men. This study is important because it may give a better understanding of…

A Single dose, two-way crossover study of the bioequivalence of two formulations of Ribavirin

To assess the bioequivalence of two marketed formulations of ribavirin (ribavirin solution and capsules).

Pancreatitis of biliary origin, Optimal timiNg of CHOlecystectomy (PONCHO)

To compare the outcome of early laparoscopic cholecystectomy (<72 hrs after randomization) with interval laparoscopic cholecystectomy (25-30 days after randomization) after mild biliary pancreatitis.

Effect of bile drainage and rifampicin, a pregnane X receptor agonist, on clinical and biochemical recovery of patients with obstructive cholestasis

To study the effect of alleviation of obstructive cholestasis by biliary drainage with or without rifampicin on serum bilirubin levels, quality of life, itch intensity, and serum and/or biliary bile salt, ATX, LPA, FGF-19 and biliary HCO3- levels in…

The effects of 4 weeks oral administration of omega-3 fatty acids on hepatic steatosis and insulin sensitivity in morbidly obese patients undergoing gastric bypass surgery.

The aim of this study is to evaluate the effect of supplementation of a high oral dose of omega-3 fatty acids on hepatic steatosis and glucose metabolism in morbidly obese patients undergoing laparoscopic Roux-Y gastric bypass surgery (LRYGBP).

Group training for Hepatitis C patients to improve quality of life

The objective of the study is to improve quality of life of patients with Hepatitis C, by teaching patients psychological skills that aid in coping with the consequences of the disease.

Influence of increasing dietary protein on hepatic fat accumulation and postprandial metabolism.

To investigate the potential beneficial effect of increasing protein in the diet in order to decrease hepatic lipid accumulation on a high-fat diet.

Extension study to the multicenter, open-label, randomized, controlled study CRAD001H2304 to evaluate the long-term efficacy and safety of concentrationcontrolled
everolimus in liver transplant recipients.

To evaluate the long-term safety and efficacy of two concentration-controlled everolimus regimen in de novo liver transplant recipients at Month 36 post-transplantation.

Kumar clamp versus Olsen cAtheter for Laparoscopic intraoperative cholAngiography (KOALA)

To assess whether cholangiography using the Kumar clamp is faster and easier than using the Olsen catheter.

Lowering viral load with nucleos(t)ide analogues prior to peg-interferon alfa-2b treatment to increase sustained response in HBeAg-positive chronic hepatitis B (PADD-study)

To investigate sustained HBeAg response to peg-interferon alfa-2b in chronic HBeAg-positive hepatitis B patients who are pretreated with nucleos(t)ide analogues, thereby lowering viral loadDetermine the effect of PEG-IFNa on NK cell function and…

Preoperative endoscopic versus percutaneous biliary drainage in potentially resectable perihilar cholangiocarcinoma: DRAINAGE Trial

This is a Dutch multi-centre study that aims to complete patient accrual through national collaboration. Patients with resectable PHC will be randomized to undergo either EBD or PTBD. The objective of the study is to identify a difference in the…

Post-Operative Pain prevention after hepato-pancreato-biliary surgery: continuous sUbfascial infiltration or ePidural analgesia? a randomized controlled non-inferiority multicenter trial

Primary Objective: To study whether CSWI+PCA provides similar analgesia after laparotomies for HPB conditions as compared to PCEA measured as the OBAS score, a composite endpoint composed of pain score, patient satisfaction and opioid related side…