An Extension Study to Learn About the Long-Term Safety of Fazirsiran and if Fazirsiran Can Help...
Alpha1-Antitrypsin DeficiencyThe main aim of this study is to learn if fazirsiran is safe during long-term use in people with liver disease caused by the abnormal Z-alpha-1 antitrypsin (Z-AAT) protein. People who are currently taking part in or have completed previous fazirsiran studies (AROAAT2001 [NCT03945292] or AROAAT2002 [NCT03946449]) can continue to receive fazirsiran in this study. Participants will receive fazirsiran every 3 months for almost 2 years and will then be followed for an additional 6 months. The study may also provide information on whether fazirsiran has a long-term effect in reducing liver fibrosis or slowing down the progression of liver fibrosis in people with liver disease due to the abnormal Z-AAT protein.
Safety and Efficacy of Fecal Microbiota Transplantation
Crohn DiseaseUlcerative Colitis25 moreThe gut microbiota is critical to health and functions with a level of complexity comparable to that of an organ system. Dysbiosis, or alterations of this gut microbiota ecology, have been implicated in a number of disease states. Fecal microbiota transplantation (FMT), defined as infusion of feces from healthy donors to affected subjects, is a method to restore a balanced gut microbiota and has attracted great interest in recent years due to its efficacy and ease of use. FMT is now recommended as the most effective therapy for CDI not responding to standard therapies. Recent studies have suggested that dysbiosis is associated with a variety of disorders, and that FMT could be a useful treatment. Randomized controlled trial has been conducted in a number of disorders and shown positive results, including alcoholic hepatitis, Crohn's disease (CD), ulcerative colitis (UC), pouchitis, irritable bowel syndrome (IBS), hepatic encephalopathy and metabolic syndrome. Case series/reports and pilot studies has shown positive results in other disorders including Celiac disease, functional dyspepsia, constipation, metabolic syndrome such as diabetes mellitus, multidrug-resistant, hepatic encephalopathy, multiple sclerosis, pseudo-obstruction, carbapenem-resistant Enterobacteriaceae (CRE) or Vancomycin-resistant Enterococci (VRE) infection, radiation-induced toxicity, multiple organ dysfunction, dysbiotic bowel syndrome, MRSA enteritis, Pseudomembranous enteritis, idiopathic thrombocytopenic purpura (ITP), and atopy. Despite FMT appears to be relatively safe and efficacious in treating a wide range of disease, its safety and efficacy in a usual clinical setting is unknown. More data is required to confirm safety and efficacy of FMT. Therefore, the investigators aim to conduct a pilot study to investigate the efficacy and safety of FMT in a variety of dysbiosis-associated disorder.
Study to Evaluate the Pharmacokinetics (PK) of E7090 (Herein Referred to as Tasurgratinib) and Its...
Hepatic ImpairmentThe primary purpose of the study is to evaluate the effects of mild and moderate hepatic impairment on PK of tasurgratinib after a single dose administration.
Effects of Time-restricted Eating Supported by Mobile Technology in Patients With Non-alcoholic...
Non-Alcoholic Fatty Liver DiseaseTime Restricted Feeding1 moreIn non-alcoholic fatty liver disease (NAFLD), it is established that calorie restriction is the most essential dietary modification. The time-restricted diet is successful lowering total calorie consumption and insulin resistance, and is anticipated to be beneficial for patients with NAFLD. Therefore, this study aims to conduct a prospective study to determine the effect of time-restricted diet via a mobile application on the amount of intrahepatic fat and 10-year cardiovascular disease risk in patients with NAFLD.
Treating Pediatric NAFLD With Nutrition
Non-Alcoholic Fatty Liver DiseaseLiver Diseases3 moreThis is a proof of concept clinical trial to compare daily intake of at least 20 grams of whole dairy fat vs habitual diet on hepatic steatosis in children with NAFLD.
Efficacy and Safety of Herombopag in Patients With Thrombocytopenia Before Hepatectomy
HepatopathyThis is a single center, randomized, controlled study, to evaluate the efficacy and safety of Herombopag in patients with Thrombocytopenia before hepatectomy.
The Evaluation of Orange Peel Fermentation on Body Fat Lowering Efficacy in Adults
OverweightFatty Liver DiseaseTo assess whether orange peel fermentation has the effect of reducing body fat in adults
An Open-Label Study Following Oral Dosing of Seladelpar to Subjects With Primary Biliary Cholangitis...
Primary Biliary CholangitisCompensated Cirrhosis1 moreThe Effect of Hepatic Impairment on The Pharmacokinetics of Seladelpar: An Open-Label Study Following Oral Dosing of Seladelpar to Subjects with Primary Biliary Cholangitis (PBC) and Hepatic Impairment (HI)
Semaglutide in Nonalcoholic Fatty Liver Disease
Non-alcoholic Fatty Liver DiseaseThe goal of this clinical trial is to test the therapeutic effect of Semaglutide in NAFLD and its sequelae in obesity and/or type 2 diabetes mellitus. The main question it aims to answer is: • Is the use of Semaglutide (oral or subcutaneous form) effective in improving NAFLD and its sequelae in obesity and/or type 2 diabetes mellitus? Participants will undergo: Abdominal ultrasound. Fibroscan with controlled attenuation parameter to assess liver stiffness (kPa) and liver steatosis (dB/m). Fibrosis-4 score requires values of age, alanine aminotransferase, aspartate aminotransferase, and platelet count. NAFLD Fibrosis Score requires values of age, BMI, platelet count, albumin, hyperglycemia, and ALT/AST ratio. Researchers will compare: Group 1 will receive oral Semaglutide for 48 weeks. Group 2 will receive injectable Semaglutide for 48 weeks. Group 3 will receive Pioglitazone and/or Vitamin E. to see if there is an improvement in liver stiffness and severity of hepatic steatosis after 48 weeks.
Probiotic Lysate (Postbiotic and Metabiotic) Supplementation for Adults NAFLD Patients (DELI_NAFLD...
Non-Alcoholic Fatty Liver DiseaseNon Alcoholic Fatty Liver2 moreThe current study aim was to conduct placebo-controlled randomize clinical trial to assess the short-term efficacy and safety of postbiotics on hepatic fat content as measured by MRI-PDFF and ultrasonography, transaminases activity, biochemichal hepatic steatosis indeces and chronic systemic inflammatory markers in NAFLD patients. The study will include 3 periods. Screening period of up to 1 weeks to assess the eligibility to inclusion/exclusion criteria. Treatment period for 3 month where the participants will receive a twice daily oral dose of postbiotics (cell lysate and DNA fragments of the probiotic strain L. rhamnosus DV - NRRLB-68023) at the assigned dose of 100mg or placebo in capsules. During this period monthly phone contacts will be done for assessment of compliance and safety concerns. Follow-up period of up to 3 month.