Clinical trials: Decompensated Cirrhosis
Hepatic Encephalopathy, Acute on Chronic Liver Failure (ACLF)
A Study to See if an Investigational Medicine Called VS-01 Can Help and How Safe it is in the Treatment of Patients With Overt Hepatic Encephalopathy
A Phase 2, Randomized, Controlled, Open-Label, Adaptive Dose Design, Proof-of-Concept Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of Two Different Dwell Times of VS-01 on Top of Standard of Care versus Standard…
- Conditions
- Hepatic Encephalopathy, Acute on Chronic Liver Failure (ACLF), Decompensated Cirrhosis
- Trial name
- NCT06987968
- Testing
- VS-01 on top of SOC (Active Treatment Group), SOC
- Where
- 6 sites in United States, France and 1 more
- Volunteers
- 3 people
- Sponsor
- Genfit
Decompensated Cirrhosis Ethanol Related
Effect of Whey Protein Versus Egg Albumen Protein Challenge on Blood Ammonia Level in Patients of Decompensated Ethanol Related Cirrhosis.
In cirrhosis, altered nitrogen metabolism and reduced hepatic clearance of ammonia contribute to the development of Minimal Hepatic Encephalopathy (MHE)-a subclinical but functionally debilitating condition.
- Trial name
- NCT07299110
- Testing
- Whey Protein, Egg Albumen
- Where
- India
- Volunteers
- 50 people
- Sponsor
- Institute of Liver and Biliary Sciences, India
Decompensated Cirrhosis, AKI - Acute Kidney Injury
Study to Evaluate the Efficacy of Intravenous Administration of Human Albumin Versus Saline Solution in Patients With descompénsate Cirrhosis Grade 1B or Higher Renal Failure
This is a phase IV, unicentric, open-label. Patients eligible for this study will be patients with AKI 1B or greater and decompensated cirrhosis from the hospital participating in the study
- Trial name
- LIVER-AKI (NCT07270874)
- Testing
- Saline solution (NaCl 0.9%)
- Volunteers
- 114 people
- Sponsor
- Fundacion Clinic per a la Recerca Biomédica
End Stage Liver Disease, Decompensated Cirrhosis of Liver
Introducing Palliative Care (PC) Within the Treatment of End Stage Liver Disease (ESLD)
This is a comparative effectiveness study of two pragmatic models aiming to introduce palliative care for end stage liver disease patients. The 2 comparators are: Model 1: Consultative Palliative Care (i.e.
- Trial name
- PAL-LIVER (NCT03540771)
- Testing
- Palliative Care
- Where
- 19 sites in United States
- Volunteers
- 1,494 people
- Sponsor
- Albert Einstein Healthcare Network
Decompensated Cirrhosis and Ascites
Oral Branched-chain Amino Acid Supplementation for Decompensated Cirrhotic Patients
The goal of this clinical trial is to compare the nutritional parameters after 12-week supplementation of branched-chain amino acids in cirrhotic patients with ascites and serum albumin less than 3 g/dL.
- Trial name
- NCT06121479
- Testing
- Branched-chain amino acid
- Where
- Thailand
- Volunteers
- 30 people
- Sponsor
- Mahidol University
Decompensated Liver Cirrhosis
TIPS in Patients With Decompensated Liver Cirrhosis
This is a single center patient registry of patients receiving a transjugular intrahepatic portosystemic shunt (TIPS) at Hannover Medical School.
- Trial name
- NCT04801290
- Testing
- TIPS insertion
- Where
- Germany
- Volunteers
- 250 people
- Sponsor
- Hannover Medical School
Decompensated Cirrhosis
National Collaborative Centre for Hepatic Regenerative Medicine (NC-CHRM): Single vs Repeated Cycle of Granulocyte Colony-Stimulating Factor (GCSF) & Darbepoetin in Early Decompensated Cirrhosis
Chronic liver disease is a growing health concern, with limited access to liver transplants. This study addresses the urgent need for alternatives by exploring regenerative therapies, like G-CSF, to boost the liver's natural…
- Trial name
- NC-CHRM (NCT07131280)
- Testing
- Gcsf, Darbepoetin, Standard Medical Treatment
- Where
- India
- Volunteers
- 110 people
- Sponsor
- Institute of Liver and Biliary Sciences, India
Decompensated Cirrhosis, Hepatitis B Virus (HBV) Infection
A Study to Predict Recompensation in Patients With Decompensated Cirrhosis Using Spleen Stiffness and Simple Blood Tests
The goal of this observational study is to learn if spleen stiffness and other non-invasive markers can help predict recompensation in people with decompensated cirrhosis who are receiving effective treatment for the cause of…
- Conditions
- Decompensated Cirrhosis, Hepatitis B Virus (HBV) Infection, Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD), Alcohol-Related Liver Disease
- Trial name
- LEAD-2 (NCT07087041)
- Where
- 28 sites in China
- Volunteers
- 735 people
- Sponsor
- Beijing Friendship Hospital
Decompensated Hepatitis B Cirrhosis
Fuzheng Huayu Tablets Reduce the Occurrence of Re-Decompensation Events in Patients With First Decompensation of Hepatitis B-Related Liver Cirrhosis: A Randomized, Double-Blind, Placebo-Controlled, Multicenter Study
This study aims to conduct a prospective, multicenter, double-blind, randomized, placebo-controlled trial. The planned sample size is 432 patients, with the ratio of the Fuzheng Huayu group to the placebo control group being 1:1.
- Trial name
- FZHYRORDFDHBLC (NCT07017426)
- Testing
- Fuzheng Huayu tablets
- Volunteers
- 432 people
- Sponsor
- Zhiyun Yang
Hepatic Encephalopathy, Decompensated Cirrhosis
BCAA vs. Rifaximin in Patients With Cirrhosis for Secondary Prophylaxis of HE
Rationale Patients who recover from an episode of overt HE(OHE) are at risk of recurrent episodes of HE and persistent minimal hepatic encephalopathy, impacting their daily functioning and mental health.
- Conditions
- Hepatic Encephalopathy, Decompensated Cirrhosis, Minimal Hepatic Encephalopathy
- Trial name
- HERB (NCT06538077)
- Testing
- Oral Branched chain Amino acid, Rifaximin 550 MG, Lactulose
- Where
- India
- Volunteers
- 336 people
- Sponsor
- Post Graduate Institute of Medical Education and Research, Chandigarh
Decompensated Cirrhosis, Cirrhotic Cardiomyopathy
Carvedilol + Simvastatin vs. Carvedilol Alone for Cirrhosis and Cirrhotic Cardiomyopathy and Impact on Hepatic Decompensation and Survival
Cirrhosis and portal hypertension are associated with a hyperdynamic circulation and decompensation events, including development of ascites, variceal bleeding, acute kidney injury, and susceptibility to infections.
- Conditions
- Decompensated Cirrhosis, Cirrhotic Cardiomyopathy, Cirrhosis, Liver, Left Ventricular Diastolic Dysfunction
- Trial name
- CIRROSTAT (NCT06431919)
- Testing
- Simvastatin 20mg, Carvedilol 3.125 mg
- Where
- India
- Volunteers
- 260 people
- Sponsor
- Post Graduate Institute of Medical Education and Research, Chandigarh
Decompensated Cirrhosis and Ascites
Effects of Long-Term Administration of Human Albumin in Participants With Decompensated Cirrhosis and Ascites
This is a phase 3, multicenter, randomized, controlled, parallel-group, and open-label clinical study to evaluate the efficacy of standard medical treatment (SMT) + Albutein 20% administration versus SMT alone in participants…
- Trial name
- PRECIOSA (NCT03451292)
- Testing
- Albutein 20%, SMT
- Where
- 66 sites in United States, Belgium and 12 more
- Volunteers
- 410 people
- Sponsor
- Grifols Therapeutics LLC
Decompensated Cirrhosis
Coagulation Parameters With Albumin in Decompensated Cirrhosis (CoPA-D).
Albumin is commonly used plasma expander in patients of decompensated cirrhosis and has been found to have many beneficial effects, with few studies showing that maintenance of serum albumin levels above 3 g/dl has improved…
- Trial name
- NCT05937048
- Testing
- Albumin, Standard of Care
- Where
- India
- Volunteers
- 120 people
- Sponsor
- Institute of Liver and Biliary Sciences, India
Cirrhosis, Decompensated Cirrhosis of Liver
Effect of Non-Selective Beta-Blockers on Outcomes in Cirrhosis Patients After Hospitalization: A Retrospective Cohort Using Target Trial Design
The goal of this observational study is to learn if non-selective beta-blockers (NSBB) improve outcomes in patients with chronic hepatitis B or C who are discharged after hospitalization for acute decompensation of cirrhosis.
- Trial name
- NCT06977685
- Testing
- Non-selective beta-blockers
- Where
- South Korea
- Volunteers
- 7,725 people
- Sponsor
- Samsung Medical Center
Decompensated Cirrhosis
Effect of Albumin Infusion on Oxidative Albumin Modification, Albumin Binding Capacity and Plasma Thiol Status
The aim of this study is to investigate the effect of albumin infusion on oxidative albumin modification, on plasma thiol status and on albumin binding capacity for DS in patients who routinely receive albumin infusion for…
- Trial name
- ALB-INFUS (NCT03214796)
- Testing
- Human albumin
- Where
- Austria
- Volunteers
- 40 people
- Sponsor
- Medical University of Graz
Viral Hepatitis B, Viral Hepatitis D
Replicor Compassionate Access Program
The goal of this compassionate access program is to provide early access to REP 2139-Mg for patients with HBV mono-infection or HBV / HDV co-infection who either have advanced (decompensated) cirrhosis or who have failed to…
- Conditions
- Viral Hepatitis B, Viral Hepatitis D, Cirrhosis, Liver, Decompensated Cirrhosis
- Trial name
- RCAP (NCT05683548)
- Testing
- REP 2139-Mg, Tenofovir Disoproxil Fumarate, Pegylated interferon alpha2a
- Where
- 13 sites in Austria, France and 3 more
- Sponsor
- Replicor Inc.
Decompensated Cirrhosis
Human Umbilical Cord-derived Mesenchymal Stem Cells for Decompensated Cirrhosis (MSC-DLC-2)
Decompensated cirrhosis has a high overall mortality rate. There is a large unmet need for safe and alternative therapeutic potions.
- Trial name
- NCT05224960
- Testing
- UC-MSCs
- Where
- 7 sites in China
- Volunteers
- 140 people
- Sponsor
- Beijing 302 Hospital
Ascites, Decompensated Cirrhosis
A Study for Evaluation of BIV201 to Reduce Ascites and Complications in Patients With Cirrhosis and Refractory Ascites
This study evaluates the addition of BIV201 (terlipressin diacetate) as a continuous infusion in addition to standard of care (diuretics and therapeutic paracentesis) for reduction of ascites and complications in adult patients…
- Trial name
- NCT04112199
- Testing
- BIV201 continuous infusion
- Where
- 10 sites in United States
- Volunteers
- 15 people
- Sponsor
- BioVie Inc.
Decompensated Cirrhosis, CMV Reactivation
Prospective Cohort Study of Complications and Outcomes in Cirrhosis
This is a multi-center, nested cohort study intended to investigate the prevalence, risk factors, and outcomes of complications in patients with acutely decompensated cirrhosis, especially focused on Cytomegalovirus (CMV)…
- Conditions
- Decompensated Cirrhosis, CMV Reactivation, Overt Hepatic Encephalopathy
- Trial name
- NCT06374511
- Testing
- Test for CMV reactivation
- Where
- China
- Volunteers
- 660 people
- Sponsor
- Nanfang Hospital, Southern Medical University
Decompensated Cirrhosis
Effect of IMO on Intestinal Microbiota Translocation in Cirrhosis
The goal of this intervention clinical trial is to learn about the protection of isomaltooligosaccharides (IMO) on intestinal bacterial translocation in patients with liver cirrhosis.
- Trial name
- NCT06134544
- Testing
- Isomaltooligosaccharides (IMO)
- Where
- China
- Volunteers
- 18 people
- Sponsor
- Nanfang Hospital, Southern Medical University