Clinical trials: Hepatic Impairment
Liver Dysfunction
Pharmacokinetics Study of Nemonoxacin Malate Capsules in Subjects With Moderate Impaired Hepatic Function
This is a single center, open-label, non-randomized, 1:1 parallel control and single dose administration study design. Healthy subjects will be matched to moderate hepatic function impaired (Child-Pugh B，7-9) subjects in age…
- Trial name
- NCT02604498
- Testing
- Nemonoxacin
- Where
- China
- Volunteers
- 20 people, healthy volunteers welcome
- Sponsor
- Zhejiang Medicine Co., Ltd.
Multiple Myeloma
A Study of the Combination of Belantamab Mafodotin, Bortezomib, and Dexamethasone (BVd) in Participants With Multiple Myeloma and Moderate Hepatic Impairment
The goal of the clinical trial is to collect safety data and information on how the body processes BVd in people with multiple myeloma (MM) who have moderate liver problems, compared with similar participants who have normal…
- Trial name
- NCT07609706
- Testing
- Belantamab mafodotin, Bortezomib, Dexamethasone
- Volunteers
- 20 people
- Sponsor
- GlaxoSmithKline
Hepatic Impairment
To Evaluate the Pharmacokinetics and Safety of Yimitasvir Phosphate Capsules in Subjects With Moderate and Severe Liver Function Impairment and in Healthy Subjects
To evaluate the pharmacokinetics and safety of Yimitasvir phosphate capsules in subjects with moderate and severe liver function impairment and healthy subjects in a single-center, non-randomized, open, single-dose administration
- Trial name
- NCT04552808
- Testing
- Yimitasvir Phosphate
- Where
- China
- Volunteers
- 16 people, healthy volunteers welcome
- Sponsor
- Sunshine Lake Pharma Co., Ltd.
Hepatic Impairment
A Phase I Study to Assess the Pharmacokinetics of Olorofim in Subjects With Hepatic Impairment
A single oral dose study to investigate the PK and safety of olorofim in mild and moderately hepatically impaired subjects compared to subjects with normal hepatic function.
- Trial name
- NCT04752540
- Testing
- Olorofim
- Where
- 2 sites in United States
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- F2G Biotech GmbH
Impaired Hepatic Function
Study of Aldafermin (NGM282) in Participants With Impaired Hepatic Function
This is an evaluation of Aldafermin (NGM282) in an open-label, single-dose and parallel group study in participants with Impaired Hepatic Function
- Trial name
- NCT04823702
- Testing
- Aldafermin
- Where
- 3 sites in United States
- Volunteers
- 36 people, healthy volunteers welcome
- Sponsor
- NGM Biopharmaceuticals, Inc
Symptomatic Neurogenic Orthostatic Hypertension, nOH
Effect of Hepatic Impairment on the Pharmacokinetics of a Single Dose of TD-9855
An open-label study to characterize the effects of mild, moderate, and severe Hepatic Impairment (HI) on the pharmacokinetics (PK) of ampreloxetine following a single oral dose in comparison with healthy volunteers with normal…
- Trial name
- NCT04200573
- Testing
- Ampreloxetine
- Where
- 2 sites in United States
- Volunteers
- 31 people, healthy volunteers welcome
- Sponsor
- Theravance Biopharma
Healthy, Hepatic Insufficiency
A Study of Canagliflozin in Study Participants With Various Degrees of Impaired Hepatic (Liver) Function
The purpose of the study is to determine the concentration of canagliflozin in blood and urine samples after the administration of canagliflozin to study participants with mild or moderate hepatic (liver) impairment compared with…
- Trial name
- NCT01186588
- Testing
- Canagliflozin
- Where
- 2 sites in United States
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Hepatic Insufficiency, Blood Coagulation Disorders
Major Liver Resection: Early Clotting Disorders and Functional Impairment.
The aim of this study is to evaluate early clotting disorders through thromboelastogram and anticoagulant proteins levels (maybe also endothelial markers) and liver function by indocyanine green clearance after major liver…
- Trial name
- NCT02813538
- Testing
- Indocyanine green clearance, Thromboelastometry
- Where
- Spain
- Volunteers
- 60 people
- Sponsor
- Hospital General Universitario Gregorio Marañon
Hepatitis C
Reversal of Hepatic Impairment in Patients With Hepatitis C Virus (HCV) and Early Decompensation of Cirrhosis
1. Achieve sustained virologic response (SVR) in patients infected with HCV genotype 1, cirrhosis, and early clinical decompensation using 12 weeks of Olysio/Sovaldi/Ribavirin (or known as…
- Trial name
- NCT02455167
- Testing
- Simeprivir (SMV), Sofosbuvir (SOF), Ribavirin (RBV)
- Where
- United States
- Volunteers
- 9 people
- Sponsor
- University of Colorado, Denver
Hepatic Impairment, Healthy
A Study to Learn How the Body Processes the Study Medicine PF-07328948 in People With and Without Reduced Liver Function
The purpose of this study is to understand the effects of decreased liver function on the study medicine (PF-07328948). People with decreased liver function may process the study medicine differently from healthy people.
- Trial name
- NCT07269301
- Testing
- PF-07328948
- Where
- 3 sites in United States
- Volunteers
- 26 people, healthy volunteers welcome
- Sponsor
- Pfizer
Hepatic Impairment
Pharmacokinetics of BAF312 in Patients With Hepatic Impairment
This study will investigate the pharmacokinetics of BAF312 in patients with mild, moderate and severe hepatic impairment compared to healthy control subjects.
- Trial name
- NCT01565902
- Testing
- BAF312
- Where
- 3 sites in Hungary, Russia
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- Novartis Pharmaceuticals
Hepatic Impairment
Pharmacokinetics of Chiglitazar in Subjects With Hepatic Impairment and Normal Hepatic Function
This Phase 1 open label study is being conducted to directly characterize the pharmacokinetic (PK) profiles of Chiglitazar following administration of a single oral dose in subjects with varying degrees of hepatic impairment…
- Trial name
- NCT05515445
- Testing
- Chiglitazar
- Where
- China
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Chipscreen Biosciences, Ltd.
Hepatic Impairment, Healthy Subjects
Safety and Pharmacokinetics of Fluzoparib in Healthy Subjects and Those With Impaired Liver Function
This study is designed to evaluate the safety and pharmacokinetics of Fluzoparib in subjects with impaired liver function in comparison with healthy subjects ,to develop dose recommendations for patients with hepatic impairment.
- Trial name
- NCT04694365
- Testing
- Fluzoparib
- Where
- China
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Jiangsu HengRui Medicine Co., Ltd.
Healthy Volunteer
A Safety And Pharmacokinetic Study of Setrobuvir Alone and In Combination With Ritonavir-Boosted Danoprevir in Subjects With Mild Hepatic Impairment Compared to Healthy Controls
This multi-center, fixed-sequence, open-label, multiple-dose, 2-period study will evaluate the safety, tolerability and pharmacokinetics of setrobuvir alone or in combination with ritonavir-boosted danoprevir in subjects with…
- Trial name
- NCT01714154
- Testing
- danoprevir, ritonavir, setrobuvir
- Where
- 3 sites in Hungary, Poland
- Volunteers
- 18 people, healthy volunteers welcome
- Sponsor
- Hoffmann-La Roche
Advanced Care Planning
A Portal-based Advance Care Planning Intervention Among Community-Dwelling Persons Living With Cognitive Impairment
The purpose of this research is to examine the feasibility of using a patient portal based advance care planning (ACP) tool to improve ACP discussions and documentation in persons living with cognitive impairment in outpatient…
- Trial name
- Portal-Voice (NCT06509373)
- Testing
- Advance Care Planning Tool - ACPVoice, Standard of Care for Advance Care Planning
- Where
- United States
- Volunteers
- 300 people
- Sponsor
- Wake Forest University Health Sciences
Healthy, Otherwise Healthy Volunteers With Mild or Moderate Hepatic Dysfunction
A Study To Compare Pharmacokinetics Of Dacomitinib (PF-00299804) Between Healthy Subjects And Subjects With Mild And Moderate Hepatic Impairment
The study will determine if there are differences in how dacomitinib is absorbed and eliminated between healthy subjects and subjects with mild and moderately impaired hepatic function.
- Trial name
- NCT01571388
- Testing
- dacomitinib
- Where
- 2 sites in United States
- Volunteers
- 25 people, healthy volunteers welcome
- Sponsor
- Pfizer
Hepatic Impairment
KD025 Hepatic Impairment Study With Normal Hepatic Function and Subjects With Varying Degrees of Hepatic Impairment
This is a study to characterize the pharmacokinetics, safety and tolerability of KD025 and KD025 metabolites in subjects with mild, moderate or severe hepatic impairment compared to healthy subjects with normal hepatic function.
- Trial name
- NCT04166942
- Testing
- KD025
- Where
- 5 sites in United States
- Volunteers
- 35 people, healthy volunteers welcome
- Sponsor
- Kadmon, a Sanofi Company
Healthy Volunteer
A Study of The Effect of Hepatic Impairment on The Pharmacokinetics of Aleglitazar
This open-label study will assess the effects of hepatic impairment on the pharmacokinetics of a single oral dose of aleglitazar in subjects with mild or moderate hepatic impairment (Child-Pugh class A or B) and in matched…
- Trial name
- NCT01197911
- Testing
- aleglitazar
- Where
- 2 sites in United States
- Volunteers
- 38 people, healthy volunteers welcome
- Sponsor
- Hoffmann-La Roche
Hepatic Impairment
Pharmacokinetics and Safety Study of Siremadlin (HDM201) in Participants With Mild, Moderate and Severe Hepatic Impairment
The main purpose of this study is to evaluate the effect of varying degrees of impaired hepatic function (by Child Pugh classification) on the plasma PK of siremadlin after a single oral dose.
- Trial name
- NCT05599932
- Testing
- Siremadlin
- Where
- 3 sites in United States
- Volunteers
- 38 people, healthy volunteers welcome
- Sponsor
- Novartis Pharmaceuticals
Hepatic Impairment
Pharmacokinetics and Metabolism of Hydrocodone Bitartrate Controlled-Release (HC-CR) in Subjects With Hepatic Impairment
Determine the influence of hepatic impairment on the pharmacokinetics and metabolism of Hydrocodone Bitartrate Extended-Release (HC-ER) 20 mg capsules
- Trial name
- NCT02242734
- Testing
- 20 mg HC-ER
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- Zogenix, Inc.