In this study, we will recruit cirrhotic patients who are undergoing endocscopic procedures as part of their standard of care. Their endoscopies will reveal whether they have portal hypertensive gastropathy. After the procedure, we will ask the patients to provide us with a stool sample, which we will assess for occult GI bleeding. For those patients who DO NOT have occult GI bleeding, they will be contacted every 6 months for 2 years to check whether they have developed GI bleeding.
This study will evaluate the safety and effectiveness of the study drug belcesiran with placebo (an inactive drug treatment) in treating Alpha-1 Antitrypsin Deficiency-Associated Liver Disease AATLD. Belcesiran or placebo will be administered subcutaneously (via a shot) in the thigh or abdomen. About 46 people will take part in this study in about 30 hospitals and clinics worldwide. If deemed eligible, subjects will be randomized (assigned into a group by chance) into 1 of 3 study cohorts (groups). Subjects in Cohorts 1 will be dosed monthly to receive a total of 7 doses. Subjects in Cohort 2 will be dosed monthly to receive a total of 13 doses. Cohort 3 will be dosed monthly for the first 6 months and then quarterly thereafter for a total of 13 doses. Subjects will be given the option for extended treatment in an optional treatment period of an additional 4 to 6 doses of either belcesiran or placebo up to 72 weeks depending on group assignment. Subjects will then enter a follow up period for up to 96 weeks depending on group assignment. Study participation will last up to 192 weeks (3.5 years).
The primary objective of this study is to assess the efficacy of rifaximin SSD-40IR versus placebo to delay the occurrence of HE-related hospitalization/emergency department visit/initiation of HE therapies.
The study is designed to evaluate the effects of the combination of zibotentan and
dapagliflozin and dapagliflozin monotherapy versus placebo on the hepatic venous pressure gradient (HVPG) response in participants with cirrhosis with features of portal hypertension at 6 weeks of treatment.
Part A is to evaluate the absolute
change in HVPG at 6 weeks from baseline in participants treated with 2.5 mg zibotentan combined with 10 mg dapagliflozin versus placebo. The primary efficacy objective for Part B is to evaluate the proportion of participants treated with 1, 2.5, or 5 mg zibotentan combined with 10 mg dapagliflozin and 10 mg dapagliflozin monotherapy versus placebo achieving a ≥ 20% decrease in HVPG or a reduction to or below 12 mmHg in HVPG
This study will evaluate male and female subjects between 18 and 70 years of age, diagnosed with decompensated cirrhosis with ascites that have developed HRS-AKI, as defined by International Club of Ascites (ICA) criteria; minimum entry serum
creatinine ≥1.5 mg/dL.
In this Phase II trial the efficacy of treatment in patients with clinically significant portal hypertension (CSPH), in compensated alcohol-related cirrhosis, will be assessed. This will be the first trial in the clinical development of the drug BI 685509 where patients will be treated for 24 weeks, and where the portal pressure will be assessed quantitatively via HVPG measurements. The trial will evaluate both short-term and long-term efficacy. The long-term assessment will be used to rule out any adaptation to sGC activation on portal pressure on chronic treatment. The trial will also provide supportive evidence for the planned Phase III development.
This is a Phase 2, randomized, double-blind, double-dummy,
placebo-controlled study evaluating the efficacy and safety of SEMA,
CILO/FIR, and their combination in subjects with compensated
cirrhosis due to NASH.
Collection of Blood to Evaluate Epigenomics and Protein Biomarkers for the Detection of Hepatocellular Carcinoma
This Phase 3 study is conducted to evaluate lanifibranor in adults with NASH and liver fibrosis stage 2 or 3 and consists of 2 parts - Part 1 and Part 2.