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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…

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…

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 randomized, double blind, placebo-controlled, multicenter phase III study of regorafenib in patients with hepatocellular carcinoma (HCC) after sorafenib

The objective of this study is to evaluate efficacy and safety of regorafenib in patients with HCC who have progressed after sorafenib.

A Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of ABT-450/Ritonavir/ABT-267 (ABT-450/r/ABT-267) and ABT-333 Co-administered with Ribavirin (RBV) in
Treatment-Experienced Adults with Genotype 1 Chronic Hepatitis C Virus (HCV) Infection (SAPPHIRE-II)

The primary objectives of this study are to compare the percentage of subjects achieving SVR12 (HCV RNA < lower limit of quantification [LLOQ] 12 weeks following treatment) of 12 weeks of treatment with ABT-450/r/ABT-267 and ABT-333 co-…

A Phase III, Randomised, Partially Double-Blind and Placebo-Controlled Study of BI 207127 in Combination with Faldaprevir and Ribavirin in Treatment-Naïve Patients with Chronic Genotype 1 HCV Infection

The aim of the study is to confirm efficacy and safety of treatment with 600 mg of BID BI207127 in combination with 120 mg QD Faldaprevir and RBV for 16 and 24 weeks in target chronically infected HCV GT1b treatment naïve patients, including a…

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).

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.

Arterial perfusion with t-PA in donation after cardiac death (DCD) to reduce the incidence of non-anastomotic biliary strictures after orthotopic liver transplantation

Prevention of NAS will result in less retransplantations due to NAS. This in turn will result in a shorter waiting list with less morbidity and more important less mortality while waiting for a donor liver. Patients will also be less often…

A Phase 3, Randomized, Single-Blind, Controlled Trial of Topical Fibrocaps* in Intraoperative Surgical Haemostasis

Primary:The primary objective of the study is to demonstrate the superiority of Fibrocaps plus gelatin sponge, as compared to gelatin sponge alone, for achieving hemostasis in subjects undergoing spine, liver, vascular or soft tissue surgery, when…

CEFTRIAXONE NEONATAL THERAPY (CEFSINT) : A RANDOMIZED CONTROLLED TRIAL TO EVALUATE THE EFFECT OF CEFTRIAXONE ON HYPERBILIRUBINEMIA

To compare in a randomized controlled trail (RCT) the risk of neonatal hyperbilirubinaemia between neonates treated with CFT and amoxicillin-clavulanic acid (augmentin, AUGM) combination versus neonates treated with the aminoglycoside, tobramycin (…

A randomized double blind placebo controlled study on the effects of fenretinide Lym-X-Sorb on insulin sensitivity in obese insulin resistant subjects

Primary objective:To assess the effects of fenretinide on hepatic and peripheral insulin sensitivity in obese, insulin resistant subjectsSecondary objective:To assess the effects of fenretinide on hepatic steatosis, body weight and body fat…

Dose-Ranging Study to Evaluate the Safety, Efficacy and Pharmacokinetics of Pegylated Interferon Lambda (BMS-914143) Monotherapy in Interferon-Naive Patients with Chronic Hepatitis B Virus Infection who are HBeAg-positive

Primary objectives:• To evaluate the safety and tolerability of BMS-914143 as measured by the frequency of SAEs and discontinuations due to AEs;• To assess the HBeAg seroconversion rate at 24 weeks off treatment (Week 72).Secondary objective• To…

A Study of INT-747 (6-ECDCA) in Combination with Ursodeoxycholic Acid (URSO®, UDCA) in Patients with Primary Biliary Cirrhosis

In patients with primary biliary cirrhosis (PBC) taking UDCA, to assess the effects of INT-747 on: Primary: - Alkaline phosphatase (AP) levels - SafetySecondary: - Hepatocellular injury and liver function - Disease-specific and general health…

COPE-trial: Colesevelam versus placebo in cholestatic pruritus, a double-blind placebo-controlled study

Pruritus is a frequent and debilitating symptom in patients with Primary Biliary Cirrhosis, Primary Sclerosing Cholangitis and other cholestatic liver diseases. Aim is to assess the effect of Colesevelam on cholestatic pruritus.

A randomized, double-blind, placebo-controlled, Phase III trial of 2 regimens of telaprevir (with and without delayed start) combined with pegylated interferon alfa-2a (Pegasys®) and ribavirin (Copegus®) in subjects with chronic genotype 1 hepatitis C infection who failed prior pegylated interferon plus ribavirin treatment.

The primary objective is to demonstrate the superior efficacy of telaprevir in combination withPeg-IFN alfa-2a and RBV compared to standard treatment in subjects with chronic HCVgenotype 1 infection who failed prior treatment with Peg-IFN plus RBV.…

Long-acting lanreotide as a volume reducing treatment of polycystic livers

efficacy of lanreotide LAR in controling total liver volume in patients with hepatic cysts as a result of ADPKD or PCLD

Double-blind, randomised, placebo-controlled, multi-centre phase III clinical study comparing the combination of ursodeoxycholic acid capsules plus budesonide capsules to ursodeoxycholic acid capsules plus placebo in the treatment of primary biliary cirrhosis

To compare the efficacy and tolerability of a combination therapy with ursodeoxycholic acid (12-16 mg/kg body weight plus budesonide (9mg/d) vs. ursodeoxycholic acid (12-16 mg/kg BW/d) plus placebo in the treatment of PBC. To study safety and…

A randomized double-blind, placebo-controlled, single and multiple ascending dose study to evaluate the safety and pharmacokinetics of OCR 002 in healthy volunteers.

SADTo evaluate the safety and tolerability of ascending single doses (SAD) of OCR 002 administered as intravenous (IV) infusions in healthy volunteersTo evaluate the plasma pharmacokinetics (PK) of phenylacetate and ornithine and glutamine after a…

A phase 1, randomized, double-blind, placebo-controlled, ascending dose study evaluating the safety, tolerability and pharmacokinetics of JTK-652 administered for two weeks in healthy male subjects

Primary objectives : to investigate the safety and tolerability of multiple oral doses of JTK-652 administered for 14 days to healthy male subjectsSecondary objectives : tot determine the pharmacokinetics of multiple oral doses of JTK-652…