Clinical trials: Cirrhosis Portal
Cirrhosis, End Stage Liver Disease
Mild Hypothermia and Acute Kidney Injury in Liver Transplantation
Acute kidney injury (AKI), or worsening kidney function, is a common complication after liver transplantation (20-90% in published studies).
- Conditions
- Cirrhosis, End Stage Liver Disease, Acute Kidney Injury, Liver Transplant; Complications
- Trial name
- MHALT (NCT03534141)
- Testing
- Esophageal cooling/warming device, Mild hypothermia, Normothermia
- Where
- 3 sites in United States
- Volunteers
- 175 people
- Sponsor
- University of California, San Francisco
End-stage Liver Disease (ESLD), Liver Transplant
A Physical Activity Program in End-state Liver Disease
The primary aim of this study is to improve both physical fitness and sarcopenia of patients with ESLD who are potentially eligible for liver transplantation through a 12-week physical training program.
- Conditions
- End-stage Liver Disease (ESLD), Liver Transplant, Sarcopenia, Poor Physical Fitness
- Trial name
- NCT02776553
- Testing
- Nutritional consultation, Physical training program, Behavioral modification therapy
- Where
- United States
- Volunteers
- 20 people
- Sponsor
- University of Arkansas
Liver Fibrosis, Hepatic Fibrosis
A Trial of IDN-6556 in Post Orthotopic Liver Transplant for Chronic HCV
This is a double-blind, multicenter study involving patients with chronic HCV infection who had a liver transplantation; developed HCV-related liver fibrosis and/or incomplete cirrhosis; achieved a sustained virologic response…
- Conditions
- Liver Fibrosis, Hepatic Fibrosis, Liver Cirrhosis, Hepatic Cirrhosis
- Trial name
- POLT-HCV-SVR (NCT02138253)
- Testing
- IDN-6556
- Where
- 35 sites in United States
- Volunteers
- 64 people
- Sponsor
- Conatus Pharmaceuticals Inc.
Cirrhosis
A Trial to Investigate the Efficacy of OPC-41061 Administered at a Dose of 7.5 mg in Patients With Hepatic Edema
OPC-41061 at 7.5 mg/day or placebo will be orally administered once daily for 7 days to cirrhosis patients with ascites despite having received treatment with conventional diuretics and the change in body weight from baseline at…
- Trial name
- NCT01050530
- Testing
- OPC-41061
- Where
- 8 sites in Japan
- Volunteers
- 162 people
- Sponsor
- Otsuka Pharmaceutical Co., Ltd.
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
Cirrhosis
A Study to Investigate Pharmacodynamics and Pharmacokinetics of OPC-41061 in Patients With Hepatic Edema
OPC-41061 at 3.75 mg/day or 7.5 mg/day will be orally administered once daily for 7 days to cirrhosis patients with ascites despite having received treatment with conventional diuretics and pharmacodynamics, pharmacokinetics…
- Trial name
- NCT01114828
- Testing
- OPC-41061
- Where
- Japan
- Volunteers
- 40 people
- Sponsor
- Otsuka Pharmaceutical Co., Ltd.
Chronic Hepatitis c, Cirrhosis, Liver
Long Term Interferon for Patients Who Did Not Clear Hepatitis C Virus With Standard Treatment
The HALT-C Trial is a National Institute of Diabetes and Digestive and Kidney Diseases sponsored, randomized clinical trial of long-term use of Peginterferon alfa-2a (pegylated interferon) in patients who failed to respond to…
- Conditions
- Chronic Hepatitis c, Cirrhosis, Liver, Fibrosis, Liver, Hepatic Cirrhosis
- Trial name
- HALT-C (NCT00006164)
- Testing
- Peginterferon alfa-2a + Ribavirin, Peginterferon alfa-2a
- Where
- 11 sites in United States
- Volunteers
- 1,050 people
- Sponsor
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Clinically Significant Portal Hypertension
The Effect of Sorafenib on Portal Pressure
Sorafenib is approved by the US FDA for the treatment of unresectable (can not operate) liver cancer and for renal cell carcinoma.
- Trial name
- NCT01714609
- Testing
- Sorafenib
- Where
- 6 sites in United States
- Volunteers
- 10 people
- Sponsor
- Yale University
Telomere Disease
Low-Dose Danazol for the Treatment of Telomere Related Diseases
Background: DNA is a structure in the body. It contains data about how the body develops and works. Telomeres are found on the end of chromosomes in DNA.
- Trial name
- NCT03312400
- Testing
- Danazol
- Where
- United States
- Volunteers
- 18 people
- Sponsor
- National Heart, Lung, and Blood Institute (NHLBI)
Cirrhosis, Portal Hypertension
Emricasan, an Oral Caspase Inhibitor, in Subjects With NASH Cirrhosis and Severe Portal Hypertension
This is a multicenter, randomized, double-blind, placebo-controlled trial involving subjects with NASH cirrhosis and severe portal hypertension (defined as HVPG ≥12 mmHg as determined by the central reader assigned to this…
- Conditions
- Cirrhosis, Portal Hypertension, Non-alcoholic Steatohepatitis
- Trial name
- ENCORE-PH (NCT02960204)
- Testing
- Emricasan
- Where
- 37 sites in United States, Germany and 1 more
- Volunteers
- 263 people
- Sponsor
- Histogen
Cirrhosis, Chronic Liver Disease
The Association With Peptic Ulcer Disease and Hepatic Vein Pressure Gradient
The aim of this study is to assess the role of portal hypertension of peptic ulcer disease in liver cirrhosis and chronic hepatitis.
- Trial name
- NCT01944878
- Where
- South Korea
- Volunteers
- 455 people
- Sponsor
- Chuncheon Sacred Heart Hospital
Liver Cirrhosis, Hepatic Cirrhosis
A Study of IDN-6556 in Cirrhotic Subjects With Portal Hypertension
This is an open-label pilot study to evaluate the safety, tolerability, and efficacy of IDN-6556 in treating portal hypertension in subjects with liver cirrhosis.
- Conditions
- Liver Cirrhosis, Hepatic Cirrhosis, Portal Hypertension
- Trial name
- PH (NCT02230683)
- Testing
- IDN-6556
- Where
- 16 sites in United States
- Volunteers
- 23 people
- Sponsor
- Conatus Pharmaceuticals Inc.
Acute Kidney Injury, Cirrhosis
NEPH-ROSIS (NEPHrology in CirRhOSIS) Pilot Trial: A Trial to Treat Acute Kidney Injury Among Hospitalized Cirrhosis Patients
The goal of this pilot, randomized, single-blind clinical trial is to estimate the effect size of a high and low mean arterial pressure (MAP)-target algorithm among cirrhosis patients hospitalized with acute kidney injury.
- Conditions
- Acute Kidney Injury, Cirrhosis, Portal Hypertension, Hepatorenal Syndrome
- Trial name
- NEPH-ROSIS (NCT06000748)
- Testing
- MAP-Target Algorithm
- Where
- United States
- Volunteers
- 14 people
- Sponsor
- University of California, San Francisco
Cirrhosis, Liver, Portal Hypertension
A Pilot Trial to Test the Feasibility of Utilizing Home Blood Pressure Monitoring to Optimize the Administration of Midodrine Among Decompensated Cirrhosis Patients
This is a randomized single-blind feasibility trial to test the utilization of home blood pressure devices to improve the clinical management of decompensated cirrhosis patients.
- Conditions
- Cirrhosis, Liver, Portal Hypertension, Ascites Hepatic
- Trial name
- WATCH (NCT05928624)
- Testing
- Withings Home Blood Pressure Device and Scale, Standard of Care
- Where
- United States
- Volunteers
- 69 people
- Sponsor
- University of California, San Francisco
Primary Biliary Cholangitis
Study of OCA in Combination With BZF Evaluating Efficacy, Safety, and Tolerability in Participants With PBC
Study to evaluate the efficacy, safety, and tolerability of investigational drug obeticholic acid (OCA) in combination with the investigational drug bezafibrate (BZF) in participants with Primary Biliary Cholangitis (PBC).
- Trial name
- NCT04594694
- Testing
- Obeticholic acid, Bezafibrate 200 MG, Bezafibrate 400 MG
- Where
- 33 sites in Australia, Belgium and 15 more
- Volunteers
- 75 people
- Sponsor
- Intercept Pharmaceuticals
Hepatic Encephalopathy, Cirrhosis
Efficacy Study of Polyethylene Glycol 3350-electrolyte Solution (GoLYTELY®) Versus Lactulose in Patients With Hepatic Encephalopathy.
This study is being done to find out if the laxative polyethylene glycol (also known as GoLYTELY® or Miralax®) can treat your hepatic encephalopathy (confusion due to your liver disease and/or cirrhosis) better and/or more safely…
- Conditions
- Hepatic Encephalopathy, Cirrhosis, Portosystemic Encephalopathy, PSE
- Trial name
- PSE (NCT01283152)
- Testing
- Polyethylene glycol 3350-electrolyte solution (GoLYTELY®), Lactulose
- Where
- United States
- Volunteers
- 50 people
- Sponsor
- University of Texas Southwestern Medical Center
Patients With Compensated Liver Cirrhosis
Assessing Portal Hypertension With Methacetin Breath Test
This study will be used to train an algorithm using Methacetin breath test (MBT) measures and to select a cut-off to determine presence or absence of Clinically Significant Portal Hypertension (CSPH) as defined by Hepatic Venous…
- Trial name
- NCT02143778
- Testing
- Methacetin Breath Test
- Where
- 8 sites in United States, France and 2 more
- Volunteers
- 246 people
- Sponsor
- Meridian Bioscience, Inc.
Cirrhosis, Liver
Using Data-Driven Implementation Strategies to Improve the Quality of Cirrhosis Care
This Veteran Affairs (VA) Quality Improvement project aims to understand which data-driven implementation strategies promote evidence based practices that improve high-quality care for Veterans with cirrhosis.
- Trial name
- NCT04178096
- Testing
- Quality Improvement Intervention
- Where
- United States
- Volunteers
- 12 people
- Sponsor
- VA Office of Research and Development
Prevention of Esophageal Varices, NASH - Nonalcoholic Steatohepatitis
Study Evaluating the Efficacy and Safety of Belapectin for the Prevention of Esophageal Varices in NASH Cirrhosis
This seamless, adaptive, two-stage, Phase 2b/3, randomized, double-blind, multicenter, parallel-groups, placebo-controlled study will assess the efficacy, safety, and tolerability of belapectin compared with placebo in patients…
- Conditions
- Prevention of Esophageal Varices, NASH - Nonalcoholic Steatohepatitis, Cirrhosis
- Trial name
- NAVIGATE (NCT04365868)
- Testing
- belapectin
- Where
- 156 sites in United States, Argentina and 13 more
- Volunteers
- 357 people
- Sponsor
- Galectin Therapeutics Inc.
Liver Cirrhosis
Zibotentan and Dapagliflozin Combination, EvAluated in Liver Cirrhosis (ZEAL Study)
This is a two part Phase IIa/b multicentre, randomised, double-blind, placebo-controlled, parallel group dose-ranging study to assess the efficacy, safety, and tolerability of the combination of zibotentan and dapagliflozin, and…
- Trial name
- ZEAL (NCT05516498)
- Testing
- Part A: zibotentan (dose B) + dapagliflozin, Part B: zibotentan (dose A) + dapagliflozin
- Where
- 50 sites in United States, Australia and 13 more
- Volunteers
- 205 people
- Sponsor
- AstraZeneca