Fibrosis, Liver

11

Review clinical trials related to Fibrosis, Liver. Use filters to narrow results by trial status, phase, treatment, biological sex and sponsor.

Condition / disease
Location
Status: Recruiting

COffee and Metabolites Modulating the Gut MicrobiomE in Colorectal caNCER

This is research study is assessing the effects of 6-g daily use of freeze-dried instant coffee on liver fat and fibrosis and the gut microbiome and metabolome in patients who have completed routine treatment (including surgery, chemotherapy and radiotherapy) for stage I-III colorectal cancer.

Participants needed: 80
Trial details
Phase: Phase 1, Phase 2Age: 18+Biological sex: AllType: InterventionalSponsor: Massachusetts General HospitalUpdated: May 5, 2026Locations: 1
Eligibility criteria

Participants must have histologically confirmed stage I, II, or III colon or rec... [+5]

Participants who are receiving any other investigational agents. [+11]

Status: Recruiting

Changes in Bile Acids and Microbiota in Patients With Hepatitis D Treated With Bulvertide

HDV is an RNA virus that infects only in the presence of HBV, affecting about 13% of HBsAg carriers. In Italy, prevalence ranges from 3.2% to 9.3%. It increases the risk of cirrhosis, fulminant hepatitis, and HCC, particularly in high-risk groups (HIV, HCV, drug users, dialysis patients). Until 2020, pegIFN was the only therapy; since 2022, bulevirtide (BLV) has been available, blocking viral entry into hepatocytes and reducing HDV RNA and liver stiffness, with efficacy in 45-48% of patients, though the optimal treatment duration remains uncertain. The gut microbiota and bile acids also play a role in fibrosis and cirrhosis progression: dysbiosis, typical in cirrhotic patients, alters bile acid metabolism and increases intrahepatic toxicity.

Participants needed: 20
Trial details
Age: 18+Biological sex: AllType: ObservationalSponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCSUpdated: Feb 24, 2026Locations: 1
Eligibility criteria

Patients with chronic HDV-related hepatitis or compensated liver cirrhosis (Chil... [+8]

Decompensated liver cirrhosis (Child-Pugh Score B or C) [+5]

Status: Recruiting

Endoscopic Ultrasound Shear Wave Elastography Study

This study shall be a prospective, multicenter, single arm, consecutive, interventional study conducted in a post-market setting using commercially available devices. Consecutive, eligible patients with clinical suspicion of MASLD or MASH reporting for an endoscopic ultrasound and liver biopsy for evaluation of fibrosis will be enrolled. EUS Shear Wave Elastography and Attenuation Imaging technologies will be compared to liver biopsy and FibroScan results and other non-invasive fibrosis screening modalities . The data collected during this study will be evaluated in accordance with the procedures set forth in the protocol. The main question\[s\] it aims to answer are: * Establish optimal cutoffs for EUS-SWE in reference to liver biopsies staging system for liver fibrosis * Evaluate the diagnostic performance of EUS-SWE compared to FibroScan (VCTE) and to other non-invasive fibrosis screening modalities (screening scores). Participants will undergo: * Endoscopic Ultrasound with Shear Wave Elastography (SWE) and Attenuation Imaging (ATI) * Liver biopsy * FibroScan

Participants needed: 300
Trial details
Age: 18+Biological sex: AllType: ObservationalSponsor: Olympus Corporation of the AmericasUpdated: Sep 15, 2025Locations: 2
Eligibility criteria

18 years of age or older [+5]

Patients with surgically altered anatomy that precludes adequate endosonographic... [+5]

Status: Recruiting

Safety and Effectiveness of Sulfasalazine in the Treatment of Liver Fibrosis/Cirrhosis.

This is a controlled, observational clinical study initiated by investigators to investigate the efficacy and safety of sulfasalazine in the treatment of cirrhosis in patients with cirrhosis. Four cohorts were planned: primary biliary cirrhosis, hepatitis B and C cirrhosis, and alcoholic cirrhosis. The four groups were divided into experimental group and control group, and the experimental group: each group of patients was orally treated sulfasalazine for 12 months, taken three times a day, each time taking 0.5g. The control group did not take sulfasalazine. After 12 months, Observe changes in patients' biochemical and imaging indicators, liver stiffness values, fecal microbiota, and metabolites before and after the use of sulfasalazine.

Participants needed: 330
Trial details
Age: 18-70Biological sex: AllType: InterventionalSponsor: The Second Affiliated Hospital of Chongqing Medical UniversityUpdated: Feb 20, 2025Locations: 2
Eligibility criteria

Sign the informed consent form before the trial and be able to complete the stud... [+1]

Those who have a history of allergies in the past, or the investigator suspects... [+14]

Status: Recruiting

Prevalence of Non-Alcoholic Fatty Liver Disease in Inflammatory Bowel Disease Patients

Non-alcoholic Fatty Liver Disease (NAFLD) refers to a spectrum of disease characterized by the presence of more than 5% of steatosis in hepatocytes of individuals who consume little or no alcohol. It ranges from simple steatosis without evidence of inflammation, to the association of steatosis and inflammation with cellular necrosis, the so-called non-alcoholic steatohepatitis (NASH). NAFLD has become increasingly common in developed countries affecting up to 38% of the population. It is mostly but not exclusively associated with metabolic syndrome including obesity, insulin resistance, and hypertension. There is growing evidence of a close interaction between the gut and the liver "Gut-liver axis", particularly in the pathogenesis of NAFLD. The pathophysiological mechanism behind this association is not well understood but involves small intestinal bacterial overgrowth (SIBO), intestinal wall inflammation and increased permeability, all leading to systemic translocation of microbial metabolites including endotoxins and pro-inflammatory markers called Pathogen Associated Molecular Pattern (PAMPs). Thus, the gut-liver interaction, mediated by cytokines and inflammatory proteins seem to be the cornerstone of this complex liver disease. Recent studies underlined the increased prevalence of NAFLD in the Inflammatory Bowel Disease (IBD) population, accounting for almost 32% of hepatic extra-intestinal manifestations of the disease. Several hypotheses have been proposed to explain the pathophysiology behind this association, encompassing chronic intestinal wall inflammation, increased intestinal permeability and altered gut microbiota or dysbiosis. To our knowledge, no studies have been conducted so far to investigate the correlation between intestinal disease activity (IBD flare versus remission state) and NAFLD incidence and behavior (progression versus regression of steato-fibrosis). We therefore aim to conduct a prospective paired study, on IBD patients followed at Saint-Pierre University Hospital, aiming to explore this correlation. In this paired study design, patients will be their own controls over the course of their disease: An evaluation of NAFLD will be done for all patients during both phases of their inflammatory bowel disease: In the active phase and in remission phase. Our primary outcome is to assess NAFLD prevalence in the IBD population followed at our institution. Secondary outcomes will be to explore NAFLD prevalence and behavior (progression versus regression of steato-fibrosis) according to IBD activity, IBD type, IBD duration and types of IBD treatments.

Participants needed: 150
Trial details
Age: 18+Biological sex: AllType: ObservationalSponsor: Centre Hospitalier Universitaire Saint PierreUpdated: Feb 7, 2025Locations: 1
Eligibility criteria

Diagnosis of IBD based on clinical, endoscopic, and histological gounds accordin... [+1]

Presence of established liver disease (including autoimmune hepatitis, primary b... [+4]

Status: Recruiting

Endoscopic Ultrasound Shear Wave for Liver Fibrosis in MASLD Patients: The RUMIPAMBA Trial

Currently, there is no description of the contribution of the endoscopic ultrasound (EUS)-guided shear wave elastography (SWE) when describing liver fibrosis in patients with screening criteria of metabolic dysfunction-associated steatotic liver disease (MASLD), with absent-to-mild liver fibrosis. Similar research has been published but using vibration-controlled transient elastography (VCTE), recommended mainly due to its lower cost and less invasiveness. However, VCTE is limited to the anatomical proportions of the patient's body, and cannot assess the right hepatic lobe with less reliability, contrary to the EUS-SWE.

Participants needed: 30
Trial details
Age: 18-79Biological sex: AllType: InterventionalSponsor: Instituto Ecuatoriano de Enfermedades DigestivasUpdated: Sep 24, 2024Locations: 1
Eligibility criteria

Patients referred for any kind of endoscopic procedure. [+2]

History of greater amounts of alcohol per week (140 g/week and 210 g/week for fe... [+3]

Status: Recruiting

Stem Cell Applications in Biliary Atresia Patients

Recently, mesenchymal stem cell (MSC) transplantation has emerged as a promising treatment for liver cirrhosis in adults. Additionally, bone marrow-derived stem cell transplantation has shown success in treating children with biliary atresia (BA). This study aims to evaluate the efficacy of Umbilical Cord-Derived Mesenchymal Stem Cell (UC-MSC) therapy in BA through a multicentric randomized controlled trial.

Participants needed: 64
Trial details
Age: 2-18Biological sex: AllType: InterventionalSponsor: Necmi Kadıoğlu HospitalUpdated: Sep 19, 2024Locations: 1
Eligibility criteria

Infants were diagnosed with liver cirrhosis due to biliary atresia following Kas... [+1]

Epilepsy [+6]

Status: Recruiting

Find HDV and Determine Its Status in Turkey

The aim of these study to determine the prevalence of hepatitis Delta virus (HDV) infections and the prognosis of HDV patients in Turkey's southeast. The investigators intend to arrange training sessions for 250 family physicians in Diyarbakir, Batman, Mardin, and Sanliurfa in order to determine those goals. The investigators will talk about diagnosing hepatitis B virus (HBV), HDV, hepatitis C virus (HCV), and Human Immunodeficiency virus (HIV) infections during these events. To ensure that patients with simultaneous HDV infection are evaluated for HIV/HCV and to detect liver fibrosis with a non-invasive method.

Participants needed: 20,000
Trial details
Age: 18+Biological sex: AllType: ObservationalSponsor: Yaşar Bayındır, MDUpdated: Aug 12, 2024Locations: 2Duration: 13 Months
Eligibility criteria

Adults (Age≥18) [+2]

There are no exclusion criteria in this study.

Status: Recruiting

Global Research Initiative for Patients Screening on MASH

GRIPonMASH will assist (primary) health care providers clinicians to implement the latest patient care pathway, as described by the European Association for the Study of the Liver (EASL), to identify patients at risk of severe metabolic dysfunction-associated steatotic liver disease (MASLD) and to raise awareness. The primary objective is to implement a transmural patient care pathway, in order to identify patients with MASLD and its progressive form metabolic dysfunction-associated steatohepatitis (MASH) in primary care centres and clinics in 10 European countries.

Participants needed: 10,000
Trial details
Age: 18-75Biological sex: AllType: ObservationalSponsor: Julius ClinicalUpdated: Aug 1, 2024Locations: 13Duration: 5 Years
Eligibility criteria

Newly diagnosed subjects should fulfil criteria for diagnosis of type 2 diabetes... [+13]

The patient is known with hepatitis B, C or HIV or any other liver condition (li... [+7]

Status: Recruiting

The Liver Care Trial

The goal of this clinical trial is to evaluate the efficacy of screening for liver disease with liver stiffness measurement on abstinence or light consumption after 6 months in individuals who are receiving treatment for alcohol use disorder and without a history of liver disease. The investigators will conduct a randomized controlled trial with concealed allocation comparing A) an invitation to a liver stiffness measurement, blood sampling and leaflet on alcohol-related disease (intervention) with B) an invitation to blood sampling (control). The primary outcome is 'abstinence or light consumption' (≤ 10 units/week) throughout the last months, and assessed 6 months after randomization.

Participants needed: 408
Trial details
Age: 18-110Biological sex: AllType: InterventionalSponsor: Zealand University HospitalUpdated: May 17, 2023Locations: 2
Eligibility criteria

Attending outpatient treatment for alcohol use disorder (international classific... [+1]

Not speaking Danish or English [+1]

Status: Recruiting

The European NAFLD Registry

The European NAFLD Registry is a prospectively recruited, observational study supporting the study of the clinical phenotype, natural history, disease outcomes and pathophysiology of Non-Alcoholic Fatty Liver Disease and Non-Alcoholic Steatohepatitis. The ultimate goals are to better understand the drivers of interpatient variation in disease pathophysiology and severity and to utilise this information to develop and validate biomarkers that, singly or in combination, enable detection and monitoring of disease progression and/or from NAFL through NASH to fibrosis and cirrhosis.

Participants needed: 10,000
Trial details
Age: 18-100Biological sex: AllType: ObservationalSponsor: Newcastle UniversityUpdated: Jan 6, 2023Locations: 37Duration: 10 Years
Eligibility criteria

Age ≥18 years. [+7]

Refusal or inability (lack of capacity) to give informed consent. [+8]