Clinical trials: Hepatic Failure
MASH - Metabolic Dysfunction-Associated Steatohepatitis, Heart Failure With Preserved Ejection Fraction (HFPEF)
Resmetirom in Patients With MASH and HFpEF
This Phase 1b multicenter randomized double-blind placebo-controlled study evaluates the safety, tolerability and hepatic pharmacodynamic effects of resmetirom in adults with metabolic dysfunction-associated steatohepatitis…
- Trial name
- NCT07830758
- Testing
- Resmetirom
- Where
- 5 sites in United States
- Volunteers
- 90 people
- Sponsor
- Madrigal Pharmaceuticals, Inc.
Kidney Failure, Liver Failure, Chronic
Custodiol-N Solution Compared With Custodiol Solution in Organ Transplantation (Kidney, Liver and Pancreas)
Synopsis Title of Study A prospective, randomized, single blind multicentre phase III study on organ preservation with Custodiol-N compared with Custodiol solution in organ transplantation (kidney, liver and pancreas) Protocol…
- Conditions
- Kidney Failure, Liver Failure, Chronic, Kidney-Pancreas Failure
- Trial name
- NCT03627013
- Testing
- Custodiol-N Solution, Custodiol HTK Solution
- Where
- 4 sites in Austria
- Volunteers
- 362 people
- Sponsor
- Dr. F. Köhler Chemie GmbH
Hepatic Insufficiency
Pharmacokinetics of Everolimus in Subjects With Hepatic Insufficiency
This clinical pharmacology research study will assess the safety and pharmacokinetics of the drug everolimus in patients with impaired hepatic function as compared to healthy volunteers.
- Trial name
- NCT00968591
- Testing
- Everolimus
- Where
- 3 sites in Germany, Russia and 1 more
- Volunteers
- 34 people, healthy volunteers welcome
- Sponsor
- Novartis Pharmaceuticals
Renal Insufficiency, Chronic, Hepatic Insufficiency
Open-Label, Single-Dose Study to Evaluate the Safety and PK of DIC075V in Subjects With Renal Insufficiency and Hepatic Impairment Compared to Healthy Subjects and Evaluate the Safety and Pharmacokinetics of HPβCD When Administered in DIC075V Compared to Sporanox® in Healthy Subjects
An open-label, single-dose study to evaluate the safety and pharmacokinetics of DIC075V in subjects with mild or moderate chronic renal insufficiency and in patients with mild chronic hepatic impairment compared.
- Conditions
- Renal Insufficiency, Chronic, Hepatic Insufficiency, Healthy
- Trial name
- NCT00805090
- Testing
- Sporanox, Diclofenac Sodium
- Where
- 4 sites in United States, United Kingdom
- Volunteers
- 37 people, healthy volunteers welcome
- Sponsor
- Javelin Pharmaceuticals
Knee Osteoarthritis
Pharmacokinetics of Imrecoxib in Subjects With Hepatic Insufficiency
This clinical research study will assess pharmacokinetics and the safety of Imrecoxib in patients with impaired hepatic function as compared to healthy volunteers.
- Trial name
- NCT02456688
- Testing
- Imrecoxib
- Where
- China
- Volunteers
- 20 people, healthy volunteers welcome
- Sponsor
- Jiangsu HengRui Medicine Co., Ltd.
Acute on Chronic Liver Failure
Safety and Performance Trial of DIALIVE Liver Dialysis Device in Acute On Chronic Liver Failure Patients
The First-In-Man study is a multi-centre, randomised, controlled, study to generate data for the evaluation of safety and performance of DIALIVE Liver Dialysis Device in 24 evaluable patients with Acute on Chronic Liver Failure…
- Trial name
- DIALIVE _ACLF (NCT03065699)
- Testing
- DIALIVE Liver Dialysis Device
- Where
- 12 sites in Austria, Belgium and 6 more
- Volunteers
- 30 people
- Sponsor
- Yaqrit Ltd
Hepatic Encephalopathy
A 6-month Efficacy, Safety, and Tolerability Study of Rifaximin In Preventing Hepatic Encephalopathy
The purpose of this study is to determine if the study drug is safe and effective in preventing hepatic encephalopathy (HE).
- Trial name
- NCT00298038
- Testing
- Rifaximin
- Volunteers
- 299 people
- Sponsor
- Bausch Health Americas, Inc.
Hepatitis C
Study to Investigate the Influence of Hepatic Insufficiency on the Pharmacokinetics of Grazoprevir (MK-5172-013)
This study will compare the pharmacokinetics (PK) of grazoprevir (MK-5172) when administered to participants with mild, moderate or severe hepatic insufficiency (assessed by the criteria of the Child-Pugh's scale) with the PK of…
- Trial name
- NCT01390428
- Testing
- Grazoprevir
- Volunteers
- 50 people, healthy volunteers welcome
- Sponsor
- Merck Sharp & Dohme LLC
Hepatic Insufficiency
Nintedanib in Volunteers With Hepatic Impairment Compared With Healthy Volunteers
The primary objective of this study is to investigate the effect of mild (Child-Pugh A, score 5-6) and moderate (Child-Pugh B, score 7-9) hepatic impairment on the pharmacokinetics, safety and tolerability of nintedanib, in…
- Trial name
- NCT02191865
- Testing
- Nintedanib
- Where
- Germany
- Volunteers
- 33 people, healthy volunteers welcome
- Sponsor
- Boehringer Ingelheim
Neoplasm Metastases, Hepatic Insufficiency
A Pharmacokinetic Study of Trabectedin in Patients With Advanced Malignancies and Hepatic Dysfunction
The purpose of this study is to characterize the pharmacokinetics (blood levels) of trabectedin after administration to patients with advanced malignancies and hepatic (liver) dysfunction.
- Trial name
- NCT01273493
- Testing
- Trabectedin, Dexamethasone
- Where
- 11 sites in United States, Belgium and 2 more
- Volunteers
- 15 people
- Sponsor
- Janssen Research & Development, LLC
Chronic Hepatitis C
Study of Efficacy and Safety of Grazoprevir (MK-5172) + Elbasvir (MK-8742) in Chronic Hepatitis C Participants With Child-Pugh (CP)-B Hepatic Insufficiency (MK-5172-059)
This study is being done to evaluate the efficacy and safety of the drug combination grazoprevir (GZR; MK-5172) + elbasvir (EBR; MK-8742) in participants with chronic hepatitis C virus (HCV) genotype (GT) 1, 4, or 6 infection and…
- Trial name
- NCT02115321
- Testing
- Grazoprevir, Elbasvir, MK-5172A
- Volunteers
- 40 people
- Sponsor
- Merck Sharp & Dohme LLC
Hepatic Encephalopathy
MNK-6105 for Patients With Cirrhosis and High Ammonia Levels Affecting Brain Function
This study is for patients with cirrhosis and hepatic encephalopathy who are in the hospital. This means they have a high ammonia level which is affecting their brain function.
- Trial name
- NCT04128462
- Testing
- MNK-6105, Standard of Care
- Sponsor
- Mallinckrodt
Pharmacokinetic Differences, Y-3
Y-3 for Injection in Patients With Hepatic Insufficiency and Healthy Subjects
The goal of this clinical trial is to assess the pharmacokinetic profiles and safety of Y-3 in subjects with mild hepatic insufficiency (Child-Pugh: grade A), moderate hepatic insufficiency (Child-Pugh: grade B) and gender, age…
- Conditions
- Pharmacokinetic Differences, Y-3, Saftey, Mild Hepatic Insufficiency
- Trial name
- NCT07055412
- Testing
- Y-3 for injection（40mg）
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Neurodawn Pharmaceutical Co., Ltd.
Hepatic Insufficiency, Healthy
Clinical Pharmacology of FYU-981 (Subjects With Hepatic Insufficiency)
The purpose of this study is to assess the pharmacokinetics, pharmacodynamics and safety after single oral administration of FYU-981 to subjects with hepatic insufficiency and with normal hepatic function.
- Trial name
- NCT03306667
- Testing
- FYU-981
- Where
- Japan
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Mochida Pharmaceutical Company, Ltd.
Hepatic Failure, Hepatic Impairment
Single Dose Pharmacokinetics of Suboxone Study in Hepatic Impaired Subjects
The objective was to determine if hepatitis C virus (HCV) infection or mild to severe hepatic impairment (Child-Pugh Classes A, B, and C) altered the PK of buprenorphine, norbuprenorphine, or naloxone.
- Conditions
- Hepatic Failure, Hepatic Impairment, Chronic Hepatitis C Infection With Hepatic Coma
- Trial name
- NCT01846455
- Testing
- 2.0mg Buprenorphine/0.5mg Naloxone, Promethazine
- Where
- 3 sites in United States
- Volunteers
- 43 people, healthy volunteers welcome
- Sponsor
- Indivior Inc.
Liver Failure
Recompensation of Exacerbated Liver Insufficiency With Hyperbilirubinemia and/or Encephalopathy and/or Renal Failure
The objective of this trial is to evaluate the impact of elimination of albumin bound substances during albumin dialysis (MARS®) on mortality and the clinical time course in patients with a recent severe clinical deterioration of…
- Trial name
- RELIEF (NCT00614146)
- Testing
- MARS device, Standard medical therapy
- Where
- 19 sites in Austria, Belgium and 7 more
- Volunteers
- 59 people
- Sponsor
- Vantive Health LLC
Acute-On-Chronic Liver Failure
Efficacy and Safety of BMSCs (CG-BM1) for ACLF Patients
The goal of this clinical trial is to learn if CG-BM1 Allogeneic Human Bone Marrow Mesenchymal Stem Cell Injection (hereinafter referred to as CG-BM1) can treat acute-on-chronic liver failure (ACLF) patients.
- Trial name
- NCT06740149
- Testing
- Bone marrow mesenchymal stem cells (low dose), Solvent of CG-BM1, Bone marrow mesenchymal stem cells (medium dose)
- Where
- China
- Volunteers
- 100 people
- Sponsor
- GuangZhou Cellgenes Biotechnology Co., Ltd.
Obesity, Hepatic Insufficiency
Study Examining The Effect Of Hepatic Impairment On Safety, Toleration And How The Body Processes An Experimental Drug
CP-945,598 is eliminated following extensive metabolism. Decrease hepatic function can affect its elimination from the body via metabolism.
- Trial name
- NCT00645021
- Testing
- CP-945,598
- Where
- 2 sites in United States
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Pfizer
Acute-on-Chronic Liver Failure (ACLF), Liver Cirrhosis
A Novel Extracorporeal Liver Support Therapy In ALCF and to Evaluate the Efficacy of DIALIVE 2.0, a Liver Dialysis Device.
This study is intended to demonstrate the efficacy and safety of the DIALIVE Liver Dialysis Device when incorporated into the standard management plan for participants with A-TANGO ACLF grade 2-4.
- Trial name
- NCT07347275
- Testing
- Standard of Care (Investigator Choice), DIALIVE 2.0 liver dialysis Device plus available Standard of Care
- Where
- United Kingdom
- Volunteers
- 72 people
- Sponsor
- Yaqrit Ltd
End Stage Liver DIsease, Liver Failure
VitaSmart HOPE System: Bridge to HOPE Registry
This is a post-market, multicenter, single-arm, observational registry evaluating real-world use of the VitaSmart HOPE System under standard of care conditions.
- Trial name
- NCT07578441
- Testing
- hypothermic oxygenated perfusion therapy of a donor liver under standard of care conditions
- Where
- United States
- Volunteers
- 5,000 people
- Sponsor
- Bridge to Life Ltd.