Clinical trials: Liver Function
Hepatitis B
A Study to Evaluate Blood Levels of Bepirovirsen in Adult Participants With Severe or Moderate Kidney Disease
This is a 2-part study where all participants will receive bepirovirsen. The study will measure how much bepirovirsen from a single dose gets into the blood, and how long it stays in the blood.
- Trial name
- B-Kind (NCT07168356)
- Testing
- Bepirovirsen
- Where
- 3 sites in United States
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Nonalcoholic Steatohepatitis (NASH), Primary Sclerosing Cholangitis (PSC)
Pharmacokinetics and Pharmacodynamics of Cilofexor in Adults With Normal and Impaired Hepatic Function
The primary objective of this study is to evaluate the single-dose pharmacokinetics of cilofexor in adults with impaired hepatic function relative to matched, healthy controls with normal hepatic function.
- Trial name
- NCT02808312
- Testing
- Cilofexor
- Where
- 5 sites in United States, New Zealand
- Volunteers
- 57 people, healthy volunteers welcome
- Sponsor
- Gilead Sciences
Hepatitis C Virus
Study to Evaluate the Pharmacokinetics of Velpatasvir in Participants With Normal Renal Function and Severe Renal Impairment
The primary objective of the study is to evaluate the single-dose pharmacokinetics (PK) of velpatasvir (formerly GS-5816) in participants with severe renal impairment using matched healthy participants as a control group.
- Trial name
- NCT02002767
- Testing
- Velpatasvir
- Where
- 5 sites in United States, New Zealand
- Volunteers
- 19 people, healthy volunteers welcome
- Sponsor
- Gilead Sciences
Hepatic Impairment, Healthy
Single-Dose, Open-Label Pharmacokinetic Study of Bardoxolone Methyl in Subjects With Mild, Moderate, and Severe Hepatic Impairment and Normal Hepatic Function
The purpose of this study is to assess the pharmacokinetic profile of bardoxolone methyl following a single oral dose of 20 mg bardoxolone methyl in subjects with mild, moderate, and severe hepatic impairment, as compared to…
- Trial name
- NCT01563562
- Testing
- Bardoxolone Methyl
- Where
- 2 sites in United States
- Volunteers
- 34 people, healthy volunteers welcome
- Sponsor
- Biogen
Pharmacokinetics
The Study to Assess the Pharmacokinetics of Pimicotinib in Subjects With Mild and Moderate Hepatic Impairment Relative to Subjects With Normal Hepatic Function
This is a phase 1, open-label, parallel-group, single-center study to evaluate the pharmacokinetics and safety of a single 25 mg oral dose of pimicotinib in subjects with mild and moderate hepatic impairment and in control…
- Trial name
- NCT06562946
- Testing
- Pimicotinib
- Where
- China
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Abbisko Therapeutics Co, Ltd
Hepatic Impairment
A Study to Evaluate the Effect of Hepatic Impairment on the Pharmacokinetics of Glasdegib
This is a Phase 1, open-label, parallel group, single dose study to investigate the effect of moderate or severe hepatic impairment on the PK of glasdegib, compared to subjects with normal hepatic function.
- Trial name
- NCT03627754
- Testing
- Glasdegib 100 mg single oral dose
- Where
- 3 sites in United States
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Pfizer
Galactose Single Point (GSP), Residual Liver Function
GSP as an Novel Indicator for Residual Liver Function in Patients With Fatty Liver
The primary objective is to determine the galactose single point (GSP) cutoff values to discriminate subjects with different hepatic function.
- Trial name
- GSP (NCT04546022)
- Testing
- Drug: G.S.P. Solution 400 mg/ml I.V. 1.25 ml/kg BW G.S.P. solution after fasting for 6 hours.
- Volunteers
- 210 people, healthy volunteers welcome
- Sponsor
- National Defense Medical Center, Taiwan
Hepatic Function Abnormal
A Pharmacokinetic and Tolerability Study of Fexinidazole in a Single Oral Dose in Adult Participants With Mild and Moderate Hepatic Impairment
In human, metabolic hepatic clearance represents a significant part of the total clearance of fexinidazole and could be decreased in patients with liver impairment, leading to some overexposure, and conversely, the formation of…
- Trial name
- NCT05607173
- Testing
- Fexinidazole (HOE239)
- Where
- 2 sites in Bulgaria, France
- Volunteers
- 21 people, healthy volunteers welcome
- Sponsor
- Sanofi
Hepatic Impairment
A Study to Evaluate AMG 133 in Participants With Varying Degrees of Hepatic Impairment or Normal Hepatic Function
The primary objective of the trial is to evaluate the pharmacokinetics (PK) of AMG 133 after a single subcutaneous (SC) dose in participants with mild, moderate, or severe hepatic impairment compared to participants with normal…
- Trial name
- NCT07428525
- Testing
- AMG 133
- Where
- 5 sites in United States
- Volunteers
- 36 people, healthy volunteers welcome
- Sponsor
- Amgen
Cirrhosis, Hepatic Encephalopathy
Brain Imaging in Patients With Chronic Liver Disease and Functional Impairment.
Hepatic encephalopathy (HE) is a frequent complication of chronic liver disease (cirrhosis) and involves a wide spectrum of problems from mild impairment of reaction times in driving and operating machinery through to…
- Trial name
- NCT00305591
- Testing
- l-ornithine l-aspartate
- Where
- United Kingdom
- Volunteers
- 50 people, healthy volunteers welcome
- Sponsor
- Imperial College London
Cirrhosis, Hepatic Carcinoma
Functional-three-dimensional Reconstruction of Liver by 99MTc-GSA-SPECT Scan
The aims of this study were divided into three parts: 1. To develop a new software to carry out the functional-three- dimensional-reconstruction of the liver by 99mTc-GSA-SPECT scintigraphy 2.
- Trial name
- GSA (NCT01350726)
- Where
- China
- Volunteers
- healthy volunteers welcome
- Sponsor
- Peking Union Medical College Hospital
Hepatic Function Abnormal, Healthy Volunteers
A Study to Evaluate the Effect of Mild and Moderate Hepatic Impairment on the Single-Dose Pharmacokinetics of Rilzabrutinib (PRN1008)
This is a single-dose study to assess the effect of mild or moderate Hepatic Impairment (HI) on the Pharmacokinetics (PK) of rilzabrutinib as well as to evaluate the safety and tolerability of rilzabrutinib in subjects with HI.
- Trial name
- NCT06444204
- Testing
- Rilzabrutinib
- Where
- 2 sites in United States
- Volunteers
- 29 people, healthy volunteers welcome
- Sponsor
- Principia Biopharma, a Sanofi Company
Hepatitis C
Pharmacokinetics and Safety of BI 201335 in Patients With Mild to Severe Renal Impairment
The main objective of this study is to investigate the influence of mild, moderate and severe renal impairment on the pharmacokinetics and safety of BI 201335 in comparison to a control group with normal renal function after…
- Trial name
- NCT01580306
- Testing
- BI 201335
- Where
- Germany
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- Boehringer Ingelheim
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
Asthma
Investigating The Pharmacokinetics Of An Inhaled Dose Of A New Corticosteroid In Patients With Impaired Liver Function
The proposed study is designed to investigate the pharmacokinetics, pharmacodynamics (as measured by serum cortisol) and safety of GW685698X in subjects with moderate hepatic impairment and in healthy subjects following a single…
- Trial name
- NCT00419237
- Testing
- GW685698X
- Volunteers
- 20 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Obesity, Liver Function
Obesity and Liver Function in Oesophageal Cancer
There is an established link between sarcopenia and outcomes in oesophageal cancer. There is scant reports in the literature regarding the influences of different obesity in different compartments.
- Trial name
- NCT04152044
- Testing
- Observation of different types of obesity and liver pathology in patients undergoing and oesophagectomy
- Where
- Ireland
- Volunteers
- 658 people, healthy volunteers welcome
- Sponsor
- St. James's Hospital, Ireland
Hepatic Impairment
A Study to Evaluate the Pharmacokinetics (PK) and Safety of a Single Dose of Treprostinil Palmitil Inhalation Powder (TPIP) in Participants With Normal Hepatic Function and Participants With Hepatic Impairment
The primary purpose of the study is to determine the effect of mild, moderate, and severe hepatic impairment on the PK of total treprostinil palmitil (TP) and treprostinil (TRE) following a single dose of 80 micrograms (μg) TPIP…
- Trial name
- NCT07643155
- Testing
- Treprostinil Palmitil Inhalation Powder
- Where
- 4 sites in United States
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- Insmed Incorporated
Diabetes Mellitus, Type 2, Liver Diseases
Validate Smart Breath Analyzer as Screening Tool for Diabetic, Hepatic, Renal, Lung, and Other Metabolic Disorders
This is a prospective, multicentric, non-treatment study to build and validate a portable, non-invasive smart breath analyzer that can screen underlying health issues using exhaled breath.
- Conditions
- Diabetes Mellitus, Type 2, Liver Diseases, Kidney Diseases, Lung Diseases
- Trial name
- RESPYR-SBA (NCT07646015)
- Where
- India
- Volunteers
- 3,000 people, healthy volunteers welcome
- Sponsor
- Respyr
Nonalcoholic Steatohepatitis (NASH)
Study to Evaluate the Pharmacokinetics of Firsocostat or Fenofibrate in Adults With Normal and Impaired Hepatic Function
The primary objectives of this study are to evaluate the single-dose pharmacokinetics (PK) of firsocostat in adults with normal hepatic function, and mild, moderate, or severe hepatic impairment and to evaluate the single-dose PK…
- Trial name
- HI (NCT02891408)
- Testing
- Firsocostat, Fenofibrate
- Where
- 5 sites in United States
- Volunteers
- 74 people, healthy volunteers welcome
- Sponsor
- Gilead Sciences
Normal Hepatic Function, Impaired Hepatic Function
Effect of Hepatic Impairment on LDE225..
This study is to evaluate the pharmacokinetics and safety of 800 mg of LDE225 in subjects with impaired hepatic function and healthy subjects with normal hepatic function.
- Trial name
- NCT01764776
- Testing
- LDE225
- Where
- 5 sites in United States, Belgium and 3 more
- Volunteers
- 33 people, healthy volunteers welcome
- Sponsor
- Novartis Pharmaceuticals