Ongoing Clinical Trials for Hepatic Cirrhosis

This article provides information about 25 ongoing clinical trials investigating various treatments for hepatic cirrhosis, a chronic liver condition where healthy tissue is replaced by scar tissue. These studies are testing medications ranging from metabolic modulators and antibiotics to cell therapies and immune system treatments, conducted across multiple European countries including Spain, Italy, Germany, France, and Belgium.

Clinical trial locations

Study of Pegozafermin Treatment for Patients with Liver Cirrhosis due to Metabolic Dysfunction-Associated Steatohepatitis (MASH)

This trial focuses on patients with Metabolic Dysfunction-Associated Steatohepatitis with compensated cirrhosis, testing a medication called pegozafermin administered through subcutaneous injection. The main goal is to determine whether pegozafermin can help improve liver scarring and prevent disease progression over a 60-month period.

Inclusion criteria: Participants must be between 18 and 75 years old and have either type 2 diabetes diagnosed at least 3 months prior or at least two metabolic risk factors. They must have confirmed MASH with stage F4 fibrosis proven by biopsy. Body Mass Index requirements are 25.0-50.0 for most participants and 23.0-50.0 for Asian participants.

Exclusion criteria: The trial excludes patients with decompensated cirrhosis, history of liver cancer, other liver diseases besides MASH, uncontrolled diabetes, significant cardiovascular disease, severe kidney disease, alcohol or substance abuse, pregnancy or breastfeeding, and participation in other recent trials.

Investigational drug: Pegozafermin is a novel medication designed to help improve liver health and potentially reverse some scarring in patients with MASH cirrhosis. It represents a new approach to treating this condition and works differently from traditional liver medications.

Study on Dapagliflozin for Patients with Decompensated Liver Cirrhosis

This Italian study evaluates dapagliflozin compared to standard treatment in patients with decompensated cirrhosis. The primary focus is on safety, with monitoring over 12 months for adverse events and complications such as variceal bleeding, hepatic encephalopathy, and fluid buildup in the abdomen.

Inclusion criteria: Participants must be between 18 and 85 years old with confirmed liver cirrhosis diagnosed through tissue examination, ultrasound, CT scan, or liver elastography. They must have experienced decompensation within the past 12 months, including symptoms like hepatic encephalopathy, significant ascites, or esophageal varices bleeding.

Exclusion criteria: Patients with decompensated liver cirrhosis are excluded from this trial, which may seem contradictory but likely refers to those at the most severe end of the spectrum who would not be suitable candidates.

Investigational drug: Dapagliflozin is a medication that helps lower blood sugar levels in type 2 diabetes. This trial investigates whether it can be safely used in patients with decompensated cirrhosis to potentially improve outcomes.

Study on Efruxifermin for Patients with Compensated Cirrhosis Due to Nonalcoholic Steatohepatitis (NASH) or Metabolic Dysfunction-Associated Steatohepatitis (MASH)

This multinational trial tests efruxifermin administered as a subcutaneous injection compared to placebo in patients with NASH or MASH cirrhosis. The study aims to determine if efruxifermin can reduce liver scarring and prevent disease progression, potentially helping patients live longer without serious liver-related complications.

Inclusion criteria: Participants must be males or non-pregnant females aged 18-80 years who can provide informed consent. They must have a history of type 2 diabetes or at least two metabolic risk factors including obesity, abnormal cholesterol, high blood pressure, or high fasting blood sugar. BMI must be 25 or higher, with specific requirements for FibroScan or ELF scores and biopsy-proven compensated cirrhosis.

Exclusion criteria: The trial excludes patients with other serious liver diseases, liver transplant recipients, those with uncontrolled diabetes, significant alcohol or drug abuse within the past year, certain heart conditions, active cancer, pregnancy or breastfeeding, participation in other trials, severe kidney disease requiring dialysis, and history of allergic reactions to similar medications.

Investigational drug: Efruxifermin is a medication being studied for its potential to help people with NASH or MASH by reducing scarring and improving liver function. It is administered as an injection and aims to provide a new treatment option for patients with these liver conditions.

Study on Fecal Microbiome Transplantation for Patients with Decompensated Cirrhosis Using Allogeneic Fecal Microbiota Capsules

This Spanish trial investigates fecal microbiome transplantation using specially prepared oral capsules in patients with decompensated cirrhosis. The goal is to evaluate whether introducing beneficial bacteria can help slow disease progression by improving the balance of gut bacteria.

Inclusion criteria: Participants must be 18 years or older with cirrhosis confirmed by standard medical tests, ultrasound, or tissue examination. Cirrhosis can be due to any cause except autoimmune hepatitis. Patients must be classified as Child-Pugh B or C with scores between 7 and 12 points. Women of childbearing potential must have negative pregnancy tests and agree to use very effective birth control methods.

Exclusion criteria: Patients with decompensated cirrhosis meeting certain severity criteria cannot participate, though the trial is designed for this population, suggesting specific exclusions relate to the most severe cases unsuitable for the intervention.

Investigational treatment: Fecal Microbiome Transplantation involves transferring stool from healthy donors into the patient’s intestines. The therapy aims to introduce beneficial bacteria that may help improve liver function and prevent further damage in decompensated cirrhosis.

Study on Human Serum Albumin and Sodium Chloride for Patients with Liver Cirrhosis and Ascites

This multi-country trial evaluates human albumin therapy combined with sodium chloride solution in patients with decompensated cirrhosis and ascites. The study aims to validate predictive biomarkers and assess how well patients respond to albumin therapy over time.

Inclusion criteria: Participants must have decompensated liver cirrhosis with Child-Pugh scores between 7 and 12, evidence of ascites confirmed by doctor or ultrasound, be 18 years or older, and have at least five days since any recent hospitalization or decompensation event.

Exclusion criteria: Patients with cirrhosis and ascites who do not meet the specified clinical trial group criteria, fall outside the age range, or belong to vulnerable populations requiring special protection are excluded.

Investigational treatment: Human Albumin is a protein naturally found in blood that helps maintain proper fluid balance. The trial investigates whether albumin therapy can help manage fluid buildup and improve overall health in patients with cirrhosis and ascites.

Study on Intestifix for Treating Immune Activation in Patients with Liver Cirrhosis and Ascites

This German study evaluates INTESTIFIX 001, an encapsulated fecal microbiota transfer, compared to placebo in patients with cirrhosis and ascites. The three-month trial focuses on safety while also measuring changes in inflammation markers, liver function scores, and quality of life.

Inclusion criteria: Participants must have cirrhosis confirmed by standard medical tests, imaging, or biopsy, along with ascites requiring recent fluid removal. They must be between 18 and 70 years old and able to swallow capsules. Patients must be mentally and physically capable of understanding the study and following its rules.

Exclusion criteria: Patients outside the specified age range, those with conditions other than cirrhosis and ascites, and those not meeting the specific clinical trial group criteria are excluded.

Investigational treatment: FMT Capsules contain beneficial bacteria from the gut. The concept is that introducing these healthy bacteria may help balance the gut microbiome and reduce immune system activation, which can be problematic in people with liver disease.

Study on Norfloxacin for Reducing Portal Hypertension in Patients with Decompensated Cirrhosis

This Austrian trial investigates whether norfloxacin can reduce portal hypertension in patients with decompensated cirrhosis over a 12-week treatment period. The study compares norfloxacin to placebo in a double-blind design.

Inclusion criteria: Participants must have decompensated cirrhosis, be undergoing liver vein catheterization, be between 18 and 80 years old, and provide written informed consent.

Exclusion criteria: Patients with portal hypertension and decompensated cirrhosis meeting certain severity criteria are excluded, though the trial is designed for this population.

Investigational drug: Norfloxacin is an antibiotic being tested to determine if it can help reduce increased blood pressure in the portal vein, potentially improving health outcomes for patients with liver issues.

Study on Stopping Esomeprazole in Patients with Liver Cirrhosis

This German study examines the effects of discontinuing proton-pump inhibitor therapy in patients with cirrhosis. Participants are randomly assigned to either stop or continue their PPI treatment, with monitoring over 12 months for unplanned hospitalizations, infections, and other complications.

Inclusion criteria: Participants must be 18 years or older with written informed consent, have confirmed liver cirrhosis, have been hospitalized or recently hospitalized due to complicated cirrhosis within 42 days, and have been taking a PPI for at least 28 days at a standard dose or less for at least 7 days before the study. They must agree to follow pregnancy prevention rules and be willing to cooperate throughout the study.

Exclusion criteria: Patients without liver cirrhosis, those outside the specified age range, those unwilling to modify their PPI therapy as required, and members of vulnerable populations may not be eligible.

Investigational treatment: Proton-Pump Inhibitors are medications that reduce stomach acid production. The trial investigates whether continuing or discontinuing long-term PPI use affects health outcomes in patients with cirrhosis.

Study on the Effect of Carvedilol for Patients with Cirrhotic Portal Hypertension

This French trial evaluates whether carvedilol, a beta-blocker medication, can effectively prevent digestive bleeding in patients with cirrhotic portal hypertension. The study monitors changes in the portosystemic gradient measured through endoscopic ultrasound over three months.

Inclusion criteria: Participants must be 18 years or older with suspected cirrhotic portal hypertension meeting Baveno VII criteria, which include specific liver elasticity measurements and platelet counts. They must not have received prior non-cardioselective beta-blocker treatment and must be affiliated with a social security scheme.

Exclusion criteria: Patients outside the age range of 18-65 years, those from vulnerable populations, those with conditions other than cirrhotic portal hypertension, those unable to take carvedilol, pregnant or breastfeeding women, participants in other trials, those with allergic reactions to similar medications, severe unstable heart conditions, severe kidney problems, and history of alcohol or drug abuse are excluded.

Investigational drug: Carvedilol is used to help prevent digestive bleeding by reducing pressure in liver blood vessels. The study aims to determine its effectiveness after one month of use.

Study on the Safety and Effectiveness of Human Plasma Proteins and Glutathione for Patients with Decompensated Cirrhosis

This Italian trial investigates Albunorm 20% solution containing human plasma proteins with at least 96% albumin, plus RITION Glutatione, administered through intravenous infusion. The six-month study assesses safety and effectiveness in patients requiring long-term albumin treatment.

Inclusion criteria: Participants must have diagnosed liver cirrhosis of any cause, ascites of grade 2 and 3 or grade 1 with diuretics at specific doses, be between 18 and 85 years old, and be able to provide written and autonomous informed consent.

Exclusion criteria: Patients with decompensated cirrhosis meeting certain severity criteria cannot participate.

Investigational treatment: The reHA solution is a specially formulated human albumin solution designed to restore albumin’s structural profile. It is being tested for effectiveness in increasing blood albumin concentration and safety in patients with decompensated cirrhosis, potentially providing a new option for long-term albumin treatment.

Summary

This collection of 25 clinical trials demonstrates substantial international research efforts focused on hepatic cirrhosis treatment, with studies distributed across multiple European countries. Germany and Spain show particularly high concentrations of trials, each hosting 10 or more studies, reflecting strong research infrastructure in these countries for liver disease.

The trials represent diverse therapeutic approaches including metabolic modulators like pegozafermin, efruxifermin, and resmetirom for NASH-related cirrhosis; microbiome-based therapies using fecal microbiota transplantation; cardiovascular medications such as dapagliflozin and carvedilol being repurposed for cirrhosis complications; and supportive treatments like human albumin therapy. Several studies focus specifically on managing complications like portal hypertension, ascites, and hepatic encephalopathy.

Notable trends include multiple trials investigating NASH and MASH cirrhosis, reflecting the growing recognition of metabolic liver disease as a major cause of cirrhosis. Several studies explore combination therapies and novel drug delivery methods, including cell-based therapies like RTX001 autologous macrophages. The presence of both early-phase safety studies and later-phase efficacy trials indicates a robust pipeline of potential treatments at various stages of development.

#1 Clinical Trials Search in Europe

Hepatic cirrhosis – Trials in Disease

Ongoing Clinical Trials for Hepatic Cirrhosis

Clinical trial locations

Study of Pegozafermin Treatment for Patients with Liver Cirrhosis due to Metabolic Dysfunction-Associated Steatohepatitis (MASH)

Study on Dapagliflozin for Patients with Decompensated Liver Cirrhosis

Study on Efruxifermin for Patients with Compensated Cirrhosis Due to Nonalcoholic Steatohepatitis (NASH) or Metabolic Dysfunction-Associated Steatohepatitis (MASH)

Study on Fecal Microbiome Transplantation for Patients with Decompensated Cirrhosis Using Allogeneic Fecal Microbiota Capsules

Study on Human Serum Albumin and Sodium Chloride for Patients with Liver Cirrhosis and Ascites

Study on Intestifix for Treating Immune Activation in Patients with Liver Cirrhosis and Ascites

Study on Norfloxacin for Reducing Portal Hypertension in Patients with Decompensated Cirrhosis

Study on Stopping Esomeprazole in Patients with Liver Cirrhosis

Study on the Effect of Carvedilol for Patients with Cirrhotic Portal Hypertension

Study on the Safety and Effectiveness of Human Plasma Proteins and Glutathione for Patients with Decompensated Cirrhosis

Summary

Ongoing Clinical Trials on Hepatic cirrhosis

A Study Comparing Human Albumin and Saline Solution for Treating Kidney Injury in Patients with Advanced Liver Cirrhosis

Study on the Effect of Carvedilol for Patients with Cirrhotic Portal Hypertension

Study on Intestifix for Treating Immune Activation in Patients with Liver Cirrhosis and Ascites

Safety and efficacy study of RTX001 autologous macrophage therapy in patients with decompensated liver cirrhosis

Study on the Safety of Human Serum Albumin and Enoxaparin in Patients with Decompensated Cirrhosis at High Risk of Poor Outcome

Study on Human Serum Albumin and Sodium Chloride for Patients with Liver Cirrhosis and Ascites

Study on the Safety of Zibotentan and Dapagliflozin for Patients with Liver Cirrhosis

Study on the Effectiveness and Safety of Hepatitis B Surface Antigen and Imiquimod in Cirrhotic Patients Unresponsive to Conventional Vaccination

Study on Zibotentan and Dapagliflozin for Patients with Liver Cirrhosis and Portal Hypertension

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Hepatic cirrhosis – Trials in Disease

Ongoing Clinical Trials for Hepatic Cirrhosis

Clinical trial locations

Summary

Ongoing Clinical Trials on Hepatic cirrhosis

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