Clinical trials: Decompensated Cirrhosis
Ascites, Variceal Bleeding
VIATORR® TIPS Study Evaluating 6-10mm Diameters (VIATIPS)
This Registry will look at patients being treated with a transjugular intrahepatic portosystemic shunt (TIPS) procedure for portal hypertension.
- Conditions
- Ascites, Variceal Bleeding, Portal Hypertension Related to Cirrhosis
- Trial name
- VIATIPS (NCT07390344)
- Testing
- GORE® VIATORR® TIPS Endoprosthesis with Controlled Expansion (6-10mm)
- Where
- 3 sites in United States
- Volunteers
- 152 people
- Sponsor
- W.L.Gore & Associates
Liver Cirrhosis
Dose-ranging Study of Rifaximin Soluble Solid Dispersion (SSD) Tablets for the Prevention of Complications of Early Decompensated Liver Cirrhosis
The primary objective of this study is to assess the efficacy of rifaximin SSD versus placebo in preventing complications of liver cirrhosis, such as all-cause mortality (death due to all causes) or hospitalization, in subjects…
- Trial name
- NCT01904409
- Testing
- Rifaximin SSD 40 mg IR tablet, Rifaximin SSD 80 mg IR tablet, Rifaximin SSD 40 mg SER tablet
- Where
- 120 sites in United States, Russia
- Volunteers
- 420 people
- Sponsor
- Bausch Health Americas, Inc.
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
HCL001 Cell Injection for Decompensated Cirrhosis: A Phase I/II Trial
Three sequential dose cohorts are predefined for single administration: Cohort 1 (1.0 × 10⁶ cells/kg), Cohort 2 (2.0 × 10⁶ cells/kg), and Cohort 3 (4.0 × 10⁶ cells/kg).
- Trial name
- HCL001 (NCT07488546)
- Testing
- Cohort 1 (1.0 × 10⁶ cells/kg), Cohort 2 (2.0 × 10⁶ cells/kg), Cohort 3 (4.0 × 10⁶ cells/kg)
- Where
- China
- Volunteers
- 39 people
- Sponsor
- Shanghai Huicun Medical Technology Co., Ltd.
Decompensated Hepatitis B Cirrhosis
Clinical Study of Human Umbilical Cord Mesenchymal Stem Cells Injection in Patients With Decompensated Hepatitis B Cirrhosis
Phase I (Single Administration, Randomized, Double-blind, Dose Escalation)Primary Objective: To evaluate the safety and tolerability of Human Umbilical Cord Mesenchymal Stem Cell Injection in patients with decompensated hepatitis…
- Trial name
- HBV-DC (NCT07413549)
- Testing
- Human Umbilical Cord Mesenchymal Stem Cells Injection
- Where
- China
- Volunteers
- 76 people
- Sponsor
- Beijing Tuohua Weiye Biotechnology Co., Ltd.
Liver Cirrhosis
Human Umbilical Cord Mesenchymal Stem Cells Transplantation for Patients With Decompensated Liver Cirrhosis
Although liver transplantation provide a option to cure patients suffering with decompensated liver cirrhosis this condition, lack of donors, postoperative complications, especially rejection, and high cost limit its application.
- Trial name
- NCT01342250
- Testing
- conventional therapy plus low dose hUC-MSCs treatment, conventional therapy plus medium dose hUC-MSCs treatment, conventional therapy plus high dose hUC-MSCs treatment
- Where
- China
- Volunteers
- 20 people
- Sponsor
- Shenzhen Beike Bio-Technology Co., Ltd.
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
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 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
Cirrhosis, Portal Hypertension
A Study Evaluating the Utility of Ambrisentan in Lowering Portal Pressure in Patients With Liver Cirrhosis
Endothelin is a human hormone which has been associated with increased portal pressure in patients with liver cirrhosis (also called portal hypertension). Ambrisentan blocks the effects of endothelin.
- Conditions
- Cirrhosis, Portal Hypertension, Ascites
- Trial name
- NCT03827200
- Testing
- Ambrisentan
- Where
- 6 sites in Spain
- Volunteers
- 19 people
- Sponsor
- Noorik Biopharmaceuticals AG
Liver Diseases, Liver Fibrosis
Post-Treatment Follow-up Study for Liver Disease Subjects With or Without Cirrhosis After Receiving Emricasan or Placebo
A post-treatment follow-up observational study for liver disease subjects with or without liver cirrhosis after receiving emricasan or placebo. Subjects must have been enrolled in a prior IDN-6556 study to be eligible.
- Conditions
- Liver Diseases, Liver Fibrosis, Liver Cirrhosis, NASH Fibrosis
- Trial name
- NCT03479125
- Testing
- Ultrasound
- Where
- 3 sites in United States
- Volunteers
- 40 people
- Sponsor
- Conatus Pharmaceuticals Inc.
Hypertension, Portal, Liver Cirrhosis
A Study to Test Whether Avenciguat Helps People With Liver Cirrhosis and High Blood Pressure in the Portal Vein (Main Vessel Going to the Liver) Who Had Bleeding in the Esophagus or Fluid Accumulation in the Belly
This study is open to adults with advanced liver cirrhosis caused by hepatitis B, hepatitis C, alcohol-related liver disease, non-alcoholic steatohepatitis or other causes.
- Trial name
- NCT06082843
- Testing
- Avenciguat
- Where
- 15 sites in United States, Austria and 8 more
- Volunteers
- 22 people
- Sponsor
- Boehringer Ingelheim
Chronic Hepatitis C, Decompensated Cirrhosis
A Study to Evaluate the Safety and Efficacy of Ombitasvir/Paritaprevir/Ritonavir and Dasabuvir With Ribavirin in Adults With Genotype 1 and Ombitasvir/Paritaprevir/Ritonavir With Ribavirin in Adults With Genotype 4 Chronic Hepatitis C Virus Infection and Decompensated Cirrhosis
The primary objectives of this study are to assess the safety and the SVR12 rate of ombitasvir/paritaprevir/ritonavir and dasabuvir with RBV in GT1-infected participants with decompensated cirrhosis.
- Conditions
- Chronic Hepatitis C, Decompensated Cirrhosis, Hepatitis C Virus
- Trial name
- TURQUOISE-CPB (NCT02219477)
- Testing
- ombitasvir/paritaprevir/ritonavir, dasabuvir, ribavirin
- Volunteers
- 36 people
- Sponsor
- AbbVie
Hepatitis C Virus Infection
Efficacy and Safety of Sofosbuvir/Velpatasvir ± Ribavirin for 12 Weeks in Adults With Chronic HCV Infection and Decompensated Cirrhosis
The primary objectives of this study are to evaluate the antiviral efficacy, safety, and tolerability of sofosbuvir/velpatasvir (SOF/VEL) fixed-dose combination (FDC) with or without ribavirin (RBV) for 12 weeks in adults with…
- Trial name
- NCT02996682
- Testing
- SOF/VEL, RBV
- Where
- 33 sites in Japan
- Volunteers
- 102 people
- Sponsor
- Gilead Sciences
Decompensated Liver Cirrhosis
An Follow-Up Study of Liver Cirrhosis
This is a follow-up study to assess safety and preliminary clinical activity of ADR-001 in patients with liver cirrhosis (Child-Pugh score; Grade B) caused by Hepatitis C or Nonalcoholic Steatohepatitis.
- Trial name
- NCT03472742
- Testing
- Mesenchymal Stem Cell
- Where
- Japan
- Volunteers
- 19 people
- Sponsor
- Rohto Pharmaceutical Co., Ltd.
Decompensated Liver Cirrhosis
Safety of Umbilical Cord Mesenchymal Stem Cells (UC-MSC) in Patients With Decompensated Hepatitis B Cirrhosis
The goal of this clinical trial is to evaluate the safety and tolerability of multiple doses of human umbilical cord mesenchymal stem cell injection in patients with decompensated hepatitis B cirrhosis, and to further explore the…
- Trial name
- NCT05948982
- Testing
- Human Umbilical Cord Mesenchymal Stem Cells
- Volunteers
- 18 people
- Sponsor
- Asia Cell Therapeutics (Shanghai) Co., Ltd.
Decompensated Cirrhosis
Companion Protocol for Methacetin Breath Test (MBT) in Conatus Protocol IDN-6556-17
This study is a companion protocol that will use the data generated by Conatus' study of emricasan under protocol IDN-6556-17.The IDN-6556-17 study is a Phase 2, multicenter, double-blind, placebo-controlled trial of Emricasan in…
- Trial name
- NCT03462576
- Testing
- Methacetin Breath Test, Emricasan
- Where
- United States
- Volunteers
- 199 people
- Sponsor
- Meridian Bioscience, Inc.
Decompensated Liver Cirrhosis
Clinical Trial of Umbilical Cord Mesenchymal Stem Cell Transfusion in Decompensated Liver Cirrhosis
Decompensated liver cirrhosis is one of the life-threatening complication of chronic liver disease. Liver transplantation currently is the only effective method that can improve the survival of these patients.
- Trial name
- NCT03529136
- Testing
- UC-MSC
- Volunteers
- 252 people
- Sponsor
- Shandong Qilu Stem Cells Engineering Co., Ltd.
Hepatitis B
hUC Mesenchymal Stem Cells (19#iSCLife®-LC) in the Treatment of Decompensated Hepatitis b Cirrhosishepatitis b Cirrhosis
1. Evaluation the safety of using human umbilical mesenchymal stem cells to treat patients with hepatitis B cirrhosis. 2. Observe the curative effect of patients with hepatitis B cirrhosis who use human umbilical mesenchymal stem…
- Trial name
- NCT03826433
- Testing
- Peripheral iv
- Where
- China
- Volunteers
- 20 people
- Sponsor
- Sclnow Biotechnology Co., Ltd.
Decompensated Liver Cirrhosis
A Study of ADR-001 in Patients With Liver Cirrhosis
This is a first-in-human Phase1/2 study of ADR-001, adipose-derived mesenchymal stem cells (AD-MSCs). The safety and preliminary efficacy are evaluated in Phase 1 in patients with liver cirrhosis caused by Hepatitis C or…
- Trial name
- NCT03254758
- Testing
- Mesenchymal stem cell
- Where
- 2 sites in Japan
- Volunteers
- 21 people
- Sponsor
- Rohto Pharmaceutical Co., Ltd.