Clinical trials: Hepatic Insufficiency
Liver Failure
Pharmacokinetics of LCP-Tacro™ Once Daily and Prograf® Twice A Day in Adult De Novo Liver Transplant Patients
The purpose of this study is to demonstrate the pharmacokinetics (PK, measuring the amount of medication in blood samples) and safety of a new medicine, LCP-Tacro™ tablets, and Prograf® capsules, a drug commonly taken by…
- Trial name
- NCT00772148
- Testing
- LCP -Tacro, Prograf
- Where
- United States
- Volunteers
- 58 people
- Sponsor
- Veloxis Pharmaceuticals
Hepatic Insufficiency
Single-Dose Pharmacokinetics of BMS-790052 in Participants With Hepatic Impairment
The purpose of this study is to assess the effects of hepatic impairment on the single dose pharmacokinetics of BMS-790052.
- Trial name
- NCT00859053
- Testing
- BMS-790052
- Where
- 2 sites in United States
- Volunteers
- 46 people, healthy volunteers welcome
- Sponsor
- Bristol-Myers Squibb
Hepatic Insufficiency, Liver Diseases
A Study Evaluating How Moderate Liver Impairment Affects the Absorption, Distribution, Metabolism, and Elimination of Sevabertinib After a Single Oral Dose
This is a research study to understand how liver impairment affects the way the body processes a new cancer medicine called sevabertinib (BAY 2927088).
- Conditions
- Hepatic Insufficiency, Liver Diseases, Pharmacokinetics, Drug Metabolism
- Trial name
- NCT07102095
- Testing
- Sevabertinib
- Where
- 2 sites in United States
- Volunteers
- 18 people, healthy volunteers welcome
- Sponsor
- Bayer
Erectile Dysfunction, Pulmonary Arterial Hypertension
Study of the Pharmacokinetics and Safety of TPN171H Tablets in Subjects With Mild ,Moderate Hepatic Insufficiency and Normal Liver Function
The study aims to investigate and compare the effect of TPN171H on subjects with mild and moderate hepatic impairment compared to healthy subjects.
- Trial name
- NCT05185011
- Testing
- TPN171H
- Where
- China
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Vigonvita Life Sciences
Hepatic Encephalopathy
Efficacy and Safety Study of Ammonul® in Patients With Grade 3 or 4 Hepatic Encephalopathy
The primary purpose of this study is to evaluate the safety and effectiveness of Ammonul® in subjects who become hospitalized with Grade 3 or 4 hepatic encephalopathy (HE).
- Trial name
- NCT00597909
- Testing
- sodium phenylacetate and sodium benzoate injection 10% / 10%
- Where
- 3 sites in United States
- Volunteers
- 1 people
- Sponsor
- Amgen
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
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 Encephalopathy
Efficacy, Safety, And Pharmacokinetics Of Rifaximin In Subjects With Severe Hepatic Impairment And Hepatic Encephalopathy
The purpose of the study is to evaluate the safety of Rifaximin or placebo in subjects with severe hepatic impairment and Hepatic Encephalopathy.
- Trial name
- NCT01846663
- Testing
- Rifaximin
- Where
- 28 sites in United States
- Volunteers
- 6 people
- Sponsor
- Bausch Health Americas, Inc.
Healthy, Hepatic Insufficiency
Study of Pirtobrutinib (LOXO-305) in Participants With Impaired Liver Function and Healthy Participants
The main purpose of this study is to measure how much of pirtobrutinib (LOXO-305) gets into the bloodstream and how long it takes the body to eliminate it in participants with impaired liver function and healthy participants.
- Trial name
- NCT06190691
- Testing
- Pirtobrutinib
- Where
- 8 sites in United States
- Volunteers
- 36 people, healthy volunteers welcome
- Sponsor
- Eli Lilly and Company
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.
HIV Infections, Hepatic Insufficiency
A Pharmacokinetic Study to Assess Nevirapine [Viramune] Levels in HIV Infected Patients With Impaired Hepatic Functions
The objective of this study was to evaluate the steady-state clearance of nevirapine among HIV-1 positive patients with hepatic fibrosis, and to examine whether the degree of hepatic impairment influences clearance.
- Trial name
- NCT00144248
- Testing
- nevirapine
- Where
- 8 sites in United States, France and 1 more
- Volunteers
- 51 people
- Sponsor
- Boehringer Ingelheim
Liver Cirrhosis
Comparing a Direct Versus an Indirect Approach to Measuring the Portalsytemic Pressure Gradients
The objective of this study is to evaluate the correlation of the calculated portosystemic pressure gradient (PPG) obtained by direct portal and hepatic pressure measurements with the EchoTip® Insight™ and indirect portal vein…
- Trial name
- NCT04987034
- Testing
- EchoTip® Insight™
- Where
- 3 sites in Belgium, Netherlands and 1 more
- Volunteers
- 35 people
- Sponsor
- Cook Research Incorporated
Insomnia, Hepatic Insufficiency
Pharmacokinetics of Suvorexant in Participants With Hepatic Insufficiency (MK-4305-017)
This study will determine whether the plasma concentration-time profile and pharmacokinetics (PK) of suvorexant (MK-4305) in participants with moderate and mild hepatic insufficiency are similar to those observed in healthy…
- Trial name
- NCT01043926
- Testing
- Suvorexant
- Volunteers
- 16 people, healthy volunteers welcome
- Sponsor
- Merck Sharp & Dohme LLC
Hepatic Insufficiency, Healthy Subjects
Pharmacokinetics Of Jaktinib In Subjects With Hepatic Impairment And Normal Hepatic Function
This multi-center, open-label, parallel-controlled, single-dose Phase 1 study is being conducted to directly characterize the pharmacokinetic (PK) profiles and safety of Jaktinib following administration of a single oral dose in…
- Trial name
- NCT04993404
- Testing
- Jaktinib Hydrochloride Tablets
- Where
- China
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Suzhou Zelgen Biopharmaceuticals Co.,Ltd
Hepatic Encephalopathy
Minimal HePatic Encephalopathy Among CiRrhotics. A Cross SEctional, Clinico-EpidEmiological, Multi-Centre, Study in Patients of PakisTan
The Preempt study is likely to help determine the frequency of patients suffering from Minimal Hepatic Encephalopathy (MHE) and are cirrhotics. It will also enable us to know about the Quality of life of these patients.
- Trial name
- Preempt (NCT02613858)
- Where
- 6 sites in Pakistan
- Volunteers
- 550 people
- Sponsor
- Abbott
PK of FG-4592, Hepatic Insufficiency
A Study to Investigate the Exposure and Safety and Tolerability of a Single Dose of FG-4592 in Subjects With Moderately Diminished Liver Function Compared to Those With Normal Liver Function
The effect of moderately diminished liver function on the exposure, safety and tolerability of a single dose of FG-4592 is studied in male and female subjects.
- Conditions
- PK of FG-4592, Hepatic Insufficiency, Healthy Subjects
- Trial name
- NCT02161224
- Testing
- FG-4592
- Where
- Bulgaria
- Volunteers
- 16 people, healthy volunteers welcome
- Sponsor
- Astellas Pharma Europe B.V.
Fulminant Hepatic Failure
Safety and Efficacy of the Extracorporeal Liver Assist Device (ELAD®) In Patients With Fulminant Hepatic Failure (FHF)
This is a multicenter, open-label, randomized, concurrent control study of subjects with FHF. Subjects meeting the eligibility requirements of the study will be randomly assigned in a 2:1 ratio to receive either standard medical…
- Trial name
- ELAD (NCT00832728)
- Testing
- Standard of Care, ELAD®
- Where
- 12 sites in United States
- Sponsor
- Vital Therapies, Inc.
Hepatic Impairment (Mild and Moderate, Child-Pugh Class A and B), Hepatic Insufficiency (MeSH ID: D048550)
Pharmacokinetics and Safety of MDR-001 in Mild and Moderate Hepatic Impairment
This is a Phase I, single-center, open-label, parallel-group study. A single oral dose of MDR-001, a GLP-1 receptor agonist, will be administered to participants with mild (Child-Pugh A) or moderate (Child-Pugh B) hepatic…
- Trial name
- NCT07550634
- Testing
- MDR-001
- Where
- China
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- MindRank AI Ltd
Chronic Liver Disease, Hepatic Encephalopathy
Effect of Probiotics in Treatment of Minimal Hepatic Encephalopathy (MHE) and Health Related Quality of Life
This study is a randomized, open, parallel group, active comparator, single center trial. Objectives of the study are hereby given below: To study the health related quality of life (HRQOL) in patients with chronic liver disease.
- Trial name
- MHE (NCT01008293)
- Testing
- VSL#3, Lactulose
- Where
- India
- Volunteers
- 120 people
- Sponsor
- CD Pharma India Pvt. Ltd.
Hepatitis C, Hepatic Insufficiency
Study Evaluating the Safety of HCV-796 in Subjects With Liver Disease and in Healthy Adults
The purpose of this study is to assess the pharmacokinetics (PK) of HCV-796 in subjects with chronic hepatic impairment and in matched healthy adults.
- Trial name
- NCT00314054
- Testing
- HCV-796
- Where
- 3 sites in United States
- Volunteers
- 27 people, healthy volunteers welcome
- Sponsor
- Wyeth is now a wholly owned subsidiary of Pfizer