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A PHASE I, SPONSOR-OPEN, INVESTIGATORBLINDED,SUBJECT-BLINDED, MULTI-CENTER,
PLACEBO-CONTROLLED STUDY TO EVALUATE SAFETY, TOLERABILITY, PHARMACOKINETICS
AND PHARMACODYNAMICS OF ORAL ADMINISTRATION OF RO7020531: (1). SINGLE
AND MULTIPLE ASCENDING DOSES IN HEALTHY MALE AND FEMALE SUBJECTS; (2). 6-WEEK
TREATMENT OF VIROLOGICALLY SUPPRESSED PATIENTS WITH CHRONIC HEPATITIS B VIRUS
INFECTION

OBJECTIVESPrimary ObjectivesThe primary objective is:* To assess the safety and tolerability of 6 weeks of treatment with RO7020531 administered orally to virologically suppressed chronic hepatitis B (CHB) patients.Secondary ObjectivesThe secondary…

Double-blind, randomized, placebo-controlled, phase II dose-finding study comparing different
doses of Rhudex granules with placebo in the treatment of primary biliary cholangitis

Primary:To evaluate the efficacy of 3 doses of RhuDex vs placebo for the treatment of PBC in patients with an inadequate response to UDCA.Secondary:• To identify efficacious RhuDex dose(s) for the treatment of PBC for further evaluation in phase III…

Per-Oral Cholangioscopy (POCS) in Liver Transplantation Patients

• To demonstrate the clinical utility of POCS in cadaveric donor or live donor liver transplantation patients referred for endoscopic retrograde cholangiopancreatography (ERCP) in the setting of a clinical suspicion of post-liver transplant bile…

Randomized, placebo-controlled, double blind, multi-centre Phase IIb study to evaluate the efficacy and safety of HepaStem in patients with acute on chronic liver failure (ACLF).

The primary objective is:to demonstrate the efficacy of 2 infusions (intravenous [i.v.]) of HepaStem at 1.0 million of cells/kg body weight (BW) (7 days apart) on the overall survival proportion at 90 days post first infusion.The secondary…

A Phase 4, Double-Blind, Randomized, Placebo-Controlled, Multicenter Study Evaluating the Effect of Obeticholic Acid on Clinical Outcomes in Subjects with Primary Biliary Cholangitis

To evaluate the effect of Obeticholic Acid on clinical outcomes in subjects with primary biliary cholangitis

Double-blind, randomised, placebo-controlled, phase IIb trial on the efficacy and safety of norursodeoxycholic acid tablets in patients with non-alcoholic steatohepatitis (NASH)

Primary objective:* To evaluate the efficacy of norursodeoxycholic acid (norUDCA) 1500 mg vs. norUDCA 1000 mg vs. placebo for the treatment of NASHSecondary objectiveTo study safety and tolerability (adverse events [AEs], laboratory parameters) of…

Intraprocedural assessment of Ablation Margins using COMPuted tomography co-registration in primary LivEr Tumor treatment with percutanEous ablation: IAMCOMPLETE primary

To investigate the feasibility of co-registration with MIRADA XD of pre- and post-ablation CT using an optimized scanning protocol. Secondary objectives will be to investigate the reproducibility of CT-CT co-registration, to determine the duration…

Efficacy of the combination of simvastatin plus rifaximin in patients with decompensated cirrhosis to prevent ACLF development: a multicenter, double-blind, placebo controlled randomized clinical trial.

The aim of this study is to assess the efficacy of oral administration of simvastatin plus rifaximin in patients with decompensated cirrhosis to halt the progression of the disease as assessed by prevention of the development of ACLF.

Modifying tacrolimus related toxicity after liver transplantation. A randomized controlled trial comparing Envarsus® and Advagraf® in de novo liver transplant recipients.

To investigate whether Envarsus® leads to a significant reduction in new onset diabetes, chronic kidney disease and new onset hypertension.

A Phase 2, Randomized, Double-blind, Placebo-controlled Study Investigating Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Two Dose Levels of Belcesiran in Patients with Alpha-1 Antitrypsin Deficiency-Associated Liver Disease

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…

Very short-course versus standard course antibiotic therapy in patients with acute ChOlangitis after
adequate endoscopic BiliaRy drAinage (COBRA trial).

The primary objective is to investigate if a very short-course of antibiotics for cholangitis after adequate drainage is non-inferior with respect to clinical cure in comparison with a standard course of antibiotics.

Primary percutaneous placement of metal stents for palliative biliary drainage in patients with a primary malignant perihilar stricture

To proof feasibility and safety of direct SEMS placement for palliative treatment of perihilar cholangiocarcinoma.

A randomised, double-blind, placebo-controlled, multicentre, Phase 3 study evaluating efficacy and safety of lanifibranor followed by an active treatment extension in adult patients with non-cirrhotic non-alcoholic steatohepatitis (NASH) and fibrosis 2 (F2)/fibrosis 3 (F3) stage of liver fibrosis

This study has been transitioned to CTIS with ID 2023-508248-23-00 check the CTIS register for the current data. Primary objectivesThis Phase 3 study is conducted to evaluate lanifibranor in adults with NASH and liver fibrosis and consists of 2…

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

HARMONY

To demonstrate the feasibility of single session minimally invasive concurrent robotic liver resection and cone beam CT-guided percutaneous ablation of colorectal liver metastases in a hybrid operating room and evaluate its outcomes.