Clinical trials: Cirrhosis
Cirrhosis
Breath Test to Assess Hepatic Metabolic Reserve and to Predict Hepatic Decompensation in Cirrhotics
The three objectives of this trial are: 1. To demonstrate that a decline in hepatic metabolic function as measured by BreathID will correlate with changes in CTP and MELD scores in patients with cirrhosis. 2.
- Trial name
- NCT00375011
- Where
- 3 sites in United States, Israel
- Volunteers
- 200 people
- Sponsor
- Meridian Bioscience, Inc.
Lysosomal Acid Lipase Deficiency, Wolman Disease
Safety, Tolerability, Efficacy, Pharmacokinetics, and Pharmacodynamics of Sebelipase Alfa in Children With Growth Failure Due to Lysosomal Acid Lipase Deficiency
This was an open-label, repeat-dose, intra-participant dose-escalation study of SBC-102 (sebelipase alfa) in children with growth failure due to lysosomal acid lipase (LAL) Deficiency.
- Trial name
- NCT01371825
- Testing
- Sebelipase alfa (SBC-102)
- Where
- 7 sites in United States, Egypt and 3 more
- Volunteers
- 9 people
- Sponsor
- Alexion Pharmaceuticals, 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
Liver Fibrosis
Liver Fibrosis Assessment With ShearWave Elastography
Chronic liver disease/fibrosis can be the result of various causes, and the result is that the liver tissue becomes stiff. ShearWave™ elastography, available on the Aixplorer® ultrasound system, is a method that can be used to…
- Trial name
- NCT02181452
- Where
- 13 sites in Belgium, China and 7 more
- Volunteers
- 2,333 people
- Sponsor
- SuperSonic Imagine
Hepatitis C Virus (HCV)
A Study of Glecaprevir (GLE)/Pibrentasvir (PIB) in Treatment-Naive Adults With Chronic Hepatitis C Virus (HCV) Genotype 1-6 Infection and Compensated Cirrhosis
A Phase 3b, single arm, open-label, multicenter study in treatment naïve adults with chronic HCV infection and compensated cirrhosis to assess the safety of 8 weeks of treatment with glecaprevir/pibrentasvir and to demonstrate…
- Trial name
- EXPEDITION-8 (NCT03089944)
- Testing
- Glecaprevir/Pibrentasvir
- Where
- 113 sites in United States, Bulgaria and 17 more
- Volunteers
- 343 people
- Sponsor
- AbbVie
Chronic Hepatitis C
A Multicenter Treatment Protocol of Daclatasvir (BMS-790052) in Combination With Sofosbuvir for the Treatment of Post-Liver Transplant Subjects With Chronic Hepatitis C
The primary objective of this program is to provide DCV for 24 weeks to be given in combination with SOF to subjects with chronic hepatitis C with decompensated cirrhosis or post-liver transplant subjects with chronic hepatitis C…
- Trial name
- NCT02161939
- Testing
- Daclatasvir (BMS-790052), Sofosbuvir
- Where
- 20 sites in United States
- Sponsor
- Bristol-Myers Squibb
Liver Fibrosis, Hepatitis C
Study of Simtuzumab in HIV and/or Hepatitis C- Infected Adults With Liver Fibrosis
The primary objective of this study is to assess the safety and tolerability of simtuzumab (formerly GS-6624) in HIV and/or hepatitis C virus (HCV)-infected adults with evidence of liver fibrosis.
- Conditions
- Liver Fibrosis, Hepatitis C, HIV, HIV/HCV Co-infection
- Trial name
- NCT01707472
- Testing
- Simtuzumab
- Where
- United States
- Volunteers
- 18 people
- Sponsor
- Gilead Sciences
Cirrhosis, Ascites
A (M)Ulti-center, Prospective, (O)Pen Label, Uncontrolled Feasibility (S)Tudy to Assess the Safety and Effectiveness of an Automatic Low Flow (A)Scites (Alfa) Pump (I)n Patients With (C)Irrhosis and Refractory or Recurrent Ascites
The study is a multi-center, prospective, open label, uncontrolled feasibility study enrolling 30 patients with refractory or recurrent ascites and cirrhosis at up to 6 sites.
- Trial name
- MOSAIC (NCT02400164)
- Testing
- alfapump system
- Where
- 6 sites in United States, Canada
- Volunteers
- 30 people
- Sponsor
- Sequana Medical N.V.
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
Primary Biliary Cholangitis
Open-Label Extension Study of Saroglitazar Magnesium in Participants With Primary Biliary Cholangitis
Open-Label Extension Study of Saroglitazar Magnesium in Participants With Primary Biliary Cholangitis
- Trial name
- NCT06427395
- Testing
- Saroglitazar Magnesium 1 mg
- Where
- 28 sites in United States, Argentina and 1 more
- Volunteers
- 102 people
- Sponsor
- Zydus Therapeutics Inc.
Liver Cirrhosis, Chronic Hepatitis C
A Study of Peginterferon Alfa-2a in Combination With Ribavirin in Chronic Hepatitis C (CHC) Patients With Compensated Liver Cirrhosis (LC)
This study evaluated the clinical response of the efficacy and safety of the combination therapy of peginterferon alfa-2a and ribavirin, compared with an antiviral treatment-free group in CHC patients with compensated LC.
- Trial name
- NCT00304551
- Testing
- peginterferon alfa-2a 180μg, peginterferon alfa-2a 90μg, ribavirin
- Where
- 8 sites in Japan
- Volunteers
- 180 people
- Sponsor
- Chugai Pharmaceutical
Primary Biliary Cholangitis, PBC
A Study to Evaluate Efficacy and Safety of an Investigational Drug Named Volixibat in Patients With Itching Caused by Primary Biliary Cholangitis
The purpose of this clinical research study is to learn more about the use of the study medicine, volixibat, for the treatment of pruritus (itching) associated with Primary Biliary Cholangitis (PBC), and to assess the possible…
- Trial name
- VANTAGE (NCT05050136)
- Testing
- Volixibat
- Where
- 130 sites in United States, Argentina and 13 more
- Volunteers
- 333 people
- Sponsor
- Mirum Pharmaceuticals, Inc.
NAFLD, Liver Fibrosis
Different Doses of ZED1227 vs. Placebo in NAFLD
This is a double-blind, randomized, multicenter, placebo-controlled, comparative, exploratory phase II dose-finding trial. The trial will be conducted with four treatment groups in the form of a parallel group comparison and will…
- Trial name
- NormaliZED (NCT05305599)
- Testing
- ZED1227
- Where
- Germany
- Volunteers
- 186 people
- Sponsor
- Dr. Falk Pharma GmbH
Liver Cirrhosis
Clinical Trial Study About Human Adipose-Derived Stem Cells in the Liver Cirrhosis
The aim of the investigators study was to investigate the safety and efficacy of autologous ADSCs for the clinical treatment of liver cirrhosis.
- Trial name
- NCT02297867
- Testing
- ADSCs
- Where
- 2 sites in Taiwan
- Volunteers
- 6 people
- Sponsor
- Gwo Xi Stem Cell Applied Technology Co., Ltd.
Hepatocellular Carcinoma (HCC)
Hepatocellular Carcinoma 3 Gene Methylation Combination Detection Kit (PCR Fluorescent Probe Method) Multicenter Clinical Trial
This clinical trial aims to systematically evaluate the clinical performance and accuracy of the HepaAiQ test kit, a multi-gene methylation assay based on PCR with fluorescent probe detection.
- Trial name
- NCT06842563
- Where
- China
- Volunteers
- 900 people
- Sponsor
- Singlera Genomics Inc.
Non-alcoholic Steatohepatitis (NASH)
A Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Orally Administered GB1211 in Participants With Suspected or Confirmed Non-alcoholic Steatohepatitis (NASH) and Liver Fibrosis
This study is a randomised, double-blind, placebo controlled, phase Ib trial in subjects with suspected or confirmed non-alcoholic steatohepatitis (NASH) and liver fibrosis
- Trial name
- NCT04607655
- Testing
- GB1211
- Sponsor
- Galecto Biotech AB
Acute-On-Chronic Liver Failure
TAK-242 in Patients With Acute Alcoholic Hepatitis
A phase 2a double-blind, randomized, placebo-controlled, multicenter, proof-of-concept study to evaluate the efficacy, safety, pharmacokinetics, and pharmacodynamics of TAK-242 in subjects with acute decompensation of…
- Trial name
- NCT04620148
- Testing
- TAK-242
- Where
- 3 sites in United Kingdom
- Volunteers
- 4 people
- Sponsor
- Akaza Bioscience Ltd
Hyponatremias, Water Intoxication
"SALT Trial" Study of Ascending Levels of Tolvaptan in Hyponatremia
This study's purpose is to determine whether tolvaptan can safely and effectively return the body's balance of sodium and water toward normal, and to characterize and quantify the potential clinical benefits of this treatment.
- Conditions
- Hyponatremias, Water Intoxication, Inappropriate ADH Syndrome, Water-Electrolyte Imbalances
- Trial name
- NCT00072683
- Testing
- tolvaptan
- Where
- 23 sites in United States
- Volunteers
- 205 people
- Sponsor
- Otsuka Pharmaceutical Development & Commercialization, Inc.
Liver Fibrosis Due to NASH
Simtuzumab (SIM, GS-6624) in the Treatment of Cirrhosis Due to NASH
The primary objective of this study is to evaluate the safety and efficacy of SIM (formerly referred to as GS-6624) in adults with compensated cirrhosis due to Non-Alcoholic Steatohepatitis (NASH).
- Trial name
- NASH (NCT01672879)
- Testing
- SIM
- Where
- 59 sites in United States, Canada and 6 more
- Volunteers
- 259 people
- Sponsor
- Gilead Sciences
Hepatitis C, Liver Cirrhosis
Effects of Low-dose Maintenance Peg Interferon Alfa-2b Therapy Versus Supportive Care in Patients With Cirrhotic Hepatitis C With HIV (Study P04371)
This is a Phase 3b, randomized, open-label, parallel-group, multi-center, multi-national study of low-dose maintenance Peg interferon alpha-2b (Peg-Intron®) in subjects with human immunodeficiency virus-hepatitis C virus…
- Conditions
- Hepatitis C, Liver Cirrhosis, HIV Infections
- Trial name
- NCT00381017
- Testing
- Peg interferon alpha-2b
- Sponsor
- Merck Sharp & Dohme LLC