Active clinical trials for "Liver Diseases"

This is a pre-market, prospective, randomized (2:1), multicenter, multi-national pivotal clinical investigation. The purpose of this investigation is to determine the clinical safety and performance of GATT-Patch as compared with TachoSil for the management of minimal, mild, or moderate bleeding during elective open liver surgery.

To test the efficacy of 6-month LGG compared to placebo in treating Alcoholic Use Disorder (AUD) and liver injury in Alcoholic Hepatitis (AH). And to evaluate the effects of LGG treatment compared to placebo on therapeutic-mechanistic markers of the gut-brain axis and pro-inflammatory activity in patients with AUD and moderate AH

The investigators conduct a randomized, double-blind, placebo-controlled study to investigate the effects of Panax Ginseng C.A. Mey Extract on liver function in adults for 8 weeks.

In developed counties Non-alcoholic fatty liver disease (NAFLD) becomes the most common cause of chronic liver disease , but its prevalence in developing countries like India is also increasing (10 -20%).Till date, there is no US-FDA approved therapy for NAFLD but drugs like metformin, pioglitazone, sitagliptin, vildagliptin Vitamin E, silymarin, statins and ezetimibe have been studied along with life style modification. Life style modifications is the current modality of treatment of NAFLD. All the above-mentioned drugs have some beneficial effects with limited use due to its adverse effects in patients of NAFLD and the study results are non-conclusive. In this scenario, a safe hepatoprotective drug to be evaluated in NAFLD.Alpha-lipoic acid (ALA) or 6,8-thioctic acid, is an endogenous molecule which functions as an important co-factor for various enzyme complexes in mitochondria and plays an important role in energy metabolism. ALA is a nutraceutical agent which also has hepatoprotective and anti-inflammatory effects.ALA is a nutraceutic having anti-inflammatory and antioxidant effects and also increasing insulin sensitivity with lesser adverse effects. The relative scarcity of a promising therapy and non-conclusiveness of the previous studies open up an arena of further research using a nutraceutic in non-diabetic NAFLD. So, the present study is designed to evaluate safety and efficacy of ALA in non-diabetic NAFLD patients.

This main aim of this trial will be to study the blood levels (known as pharmacokinetics) of the study drug tazemetostat. The pharmacokinetics of the study drug in participants with advanced solid tumors and moderate or severe hepatic (liver) impairment will be compared with participants with advanced malignancies and normal hepatic function. An advanced malignancy is a cancer that has recurred (come back) after prior treatment or hasn't controlled with treatment. The trial will also study the safety of the study drug in participants (how well it is tolerated).

Lurbinectedin is mainly eliminated by the liver. Thus, Hepatic Impairment (HI) may alter the plasma concentrations of lurbinectedin. This study is designed to examine the PK and safety of an adjusted dose of lurbinectedin when administered to patients with HI. The results of this study may be used to support future clinical studies in patients and prescribing information in future labeling.

A Randomized Phase 2a Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of FM101 in Adults with Nonalcoholic Fatty Liver Disease or Nonalcoholic Steatohepatitis

The goal of this phase 1 study is to assess the pharmacokinetics, safety and tolerability following multiple oral doses of TVB-2640 in subjects with mild, moderate, or severe hepatic impairment compared to healthy subjects with normal hepatic function.

This study will be conducted in 2 parts. Part 1 will comprise of participants with mild and moderate HI and matching healthy control participants with normal hepatic function. Part 2 will comprise of participants with severe HI and matching healthy control participants with normal hepatic function. Each study part will comprise of a screening period of up to 28 days, a baseline evaluation on Day -1, and a treatment period including up to 8 days of safety and PK data collection. Participants will be domiciled from Day -1 through Day 8. All participants will receive 25 mg remibrutinib b.i.d. orally on Days 1 and 2, and a morning oral dose of 25 mg remibrutinib on Day 3. PK samples will be collected pre dose on Day 3 and until 72 hours post Day 3 dosing. Throughout the study, safety assessments will include physical examinations, ECGs, vital signs, clinical laboratory evaluations (hematology, chemistry, urinalysis and coagulation) and AE / serious adverse event (SAE) monitoring. The Investigator and Novartis will conduct a joint interim review of safety and PK data from Part 1 before proceeding to Part 2. Part 2 will only begin if administration of remibrutinib in Part 1 is deemed safe and tolerable by the Investigator and Novartis to proceed in participants with severe HI. Depending on the outcome of the interim review, administration of a lower dose of remibrutinib in severe HI participants and their matching healthy control participants may be considered. Part 2 will also include sentinel dosing where one participant with severe HI will receive the first dose of remibrutinib at least 1 week before the remaining participants. If the Investigator concludes that there are no emergent safety concerns for the sentinel participant, then dosing will commence for the remaining participants. Study Completion evaluations will occur on Day 8, followed by a post-study safety follow up contact (e.g. follow-up telephone call, email) approximately 30 days after the last administration of study treatment. The total study duration for each participant is expected to be up to approximately 62 days, including the Screening period and the follow-up contact.

We aim to determine the effect of combined isocaloric time restricted eating and meal timing on metabolic health, liver fat, functional brain networks, inflammation, and sleep pattern/quality in subjects with obesity and insulin resistance.