Clinical trials: Hepatic Function
Normal Hepatic Function, Impaired Hepatic Function
Evaluation of Hepatic Function Impairment on the Pharmacokinetics of LEE011
The purpose of this study is to evaluate the pharmacokinetics (PK), safety and tolerability of a single oral dose of LEE011 in subjects with varying degrees of impaired hepatic function (based on Child-Pugh classification) as…
- Trial name
- NCT02388620
- Testing
- LEE011
- Where
- 3 sites in United States
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- Novartis Pharmaceuticals
Non-small Cell Lung Cancer
Almonertinib Therapy in Patients With Abnormal Liver Function After EGFR-TKI Treatment, or Almonertinib First-line Therapy in Patients With Basic Hepatopathy
To assess the efficacy and safety of Almonertinib therapy in patients with abnormal liver function after first/second generation EGFR-TKI treatment, or Almonertinib first-line therapy in patients with basic hepatopathy and…
- Trial name
- NCT05662813
- Testing
- Almonertinib
- Where
- China
- Volunteers
- 55 people
- Sponsor
- West China Hospital
Primary Biliary Cholangitis
A Study of the Pharmacokinetics and Safety of CS0159 in Subjects With Hepatic Injury
Phase I Study of the Pharmacokinetics and Safety of CS0159 in Subjects With Hepatic Injury
- Trial name
- NCT06888115
- Testing
- CS0159
- Where
- 3 sites in China
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Cascade Pharmaceuticals, Inc
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.
Rheumatoid Arthritis
Study to Evaluate the Pharmacokinetics of Filgotinib in Participants With Impaired Hepatic Function
The primary objective of this study is to evaluate the pharmacokinetics (PK) of filgotinib and its metabolite, GS-829845, in participants with varying degrees of impaired hepatic function relative to matched, healthy controls.
- Trial name
- NCT03417778
- Testing
- Filgotinib
- Where
- 4 sites in United States, Germany and 1 more
- Volunteers
- 20 people, healthy volunteers welcome
- Sponsor
- Gilead Sciences
Severe Hepatic Impairment, Normal Hepatic Function
Pharmacokinetic Study of Vorasidenib in Severe Hepatically Impaired and Matched-Control Participants
The objective of this study is to evaluate the pharmacokinetics, safety, and tolerability of one dose of vorasidenib in participants with severe impaired hepatic function compared to participants with normal hepatic function.
- Trial name
- NCT07250633
- Testing
- Vorasidenib 20mg
- Where
- 3 sites in United States
- Volunteers
- 20 people, healthy volunteers welcome
- Sponsor
- Institut de Recherches Internationales Servier (I.R.I.S.)
Advanced Solid Tumors, Relapsed/Refractory Lymphoma
Pharmacokinetics of Alisertib in Adults With Advanced Solid Tumors or Relapsed/Refractory Lymphoma With Varying Degrees of Hepatic Function
The purpose of this study is to evaluate the effect of moderate or severe hepatic impairment on the single-dose pharmacokinetics of alisertib in adult participants with cancer.
- Trial name
- NCT02214147
- Testing
- Alisertib
- Where
- 7 sites in United States
- Volunteers
- 36 people
- Sponsor
- Millennium Pharmaceuticals, Inc.
Hepatic Impairment
Pharmacokinetics and Safety of ALKS 5461 in Healthy Subjects and Subjects With Hepatic Impairment and Normal Hepatic Function
This study will evaluate the effect of various degrees of hepatic function on the pharmacokinetics and safety of ALKS 5461.
- Trial name
- NCT02452801
- Testing
- ALKS 5461
- Where
- United States
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- Alkermes, Inc.
Terlipressin Adverse Reaction, Ascites Hepatic
The Effect of Terlipressin on Recovery of Liver Function After Hepatectomy
Portal vein hypertension is associated with post-hepatectomy liver failure in patients with liver cirrhosis. Our previous study found that bolus injection of 1 mg terlipressin immediately after hepatectomy decreased portal vein…
- Conditions
- Terlipressin Adverse Reaction, Ascites Hepatic, Liver Failure, Acute Kidney Injury
- Trial name
- NCT04221672
- Testing
- Terlipressin plus standard care, Standard care
- Where
- 4 sites in China
- Volunteers
- 86 people
- Sponsor
- Shanghai Zhongshan Hospital
Liver Elastography, Liver Steatosis
Impact of a Probiotic Supplementation With Lifestyle Modification on Liver Steatosis, Fibrosis, and Metabolic Health in Patients With Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD)
Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD) is the new clinical term introduced in 2023 to redefine what was formerly known as Non-Alcoholic Fatty Liver Disease (NAFLD).
- Conditions
- Liver Elastography, Liver Steatosis, Liver Function Test, Insulin Resistance
- Trial name
- NCT07400367
- Testing
- Probiotic product, Life style modification
- Where
- 2 sites in Taiwan
- Volunteers
- 80 people
- Sponsor
- Fu Jen Catholic University Hospital
Liver Dysfunction
A Pharmacokinetic Study of CKD-501 in Patients With Impaired Hepatic Function
The purpose of this study is to evaluate pharmacokinetics of CKD-501 in patients with impaired hepatic function compared with normal hepatic function.
- Trial name
- NCT02005744
- Testing
- CKD-501
- Where
- South Korea
- Volunteers
- 26 people, healthy volunteers welcome
- Sponsor
- Chong Kun Dang Pharmaceutical
Moderate Hepatic Impairment
A Pharmacokinetic Study of Mitapivat in Participants With Moderate Hepatic Impairment Compared to Matched Healthy Control Participants With Normal Hepatic Function
The primary purpose of this study is to compare the pharmacokinetics (PK) of a single oral dose of mitapivat in participants with moderate hepatic impairment to that in matched healthy control participants with normal hepatic…
- Trial name
- NCT05610657
- Testing
- Mitapivat
- Where
- 3 sites in United States
- Volunteers
- 20 people, healthy volunteers welcome
- Sponsor
- Agios Pharmaceuticals, Inc.
Gaucher Disease
A Study of the Effects of Hepatic Impairment on the Pharmacokinetics and Tolerability of Eliglustat Tartrate
Primary Objective: To study the effect of mild and moderate hepatic impairment on the pharmacokinetics (PK) of eliglustat. Secondary Objective: To assess the tolerability of eliglustat tartrate given as a single dose in subjects…
- Trial name
- NCT02536911
- Testing
- eliglustat
- Where
- 2 sites in United States
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Genzyme, a Sanofi Company
Healthy Adult Participants, Hepatic Impairment (HI)
A Pharmacokinetic Study of D-2570 in Participants With Hepatic Impairment and Normal Hepatic Function
This is a single-center, non-randomized, open-label, parallel-group study. It will test D-2570 in people with liver problems and in people with healthy livers, to see how the drug moves through the body and whether it is safe.
- Trial name
- NCT07715149
- Testing
- D-2570
- Where
- China
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- InventisBio Co., Ltd
Healthy, Liver Diseases
Single Dose of BI 1744 CL in Patients With Mild and Moderate Hepatic Impairment Compared to Subjects With Normal Hepatic Function
The main objective of this study was to investigate the influence of mild and moderate liver impairment on the pharmacokinetics, safety and selected pharmacodynamic parameters of BI 1744 CL in comparison to a control group with…
- Trial name
- NCT02171832
- Testing
- BI 1744 CL, low dose, BI 1744 CL, high dose
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- Boehringer Ingelheim
Alcohol Dependence
Treatment of Patients Suffering of Alcohol Dependence and Impaired Liver Function With Selincro® As-needed Use
The purpose of this study is to explore the treatment effects of Selincro in alcohol dependent patients with liver impairment.
- Trial name
- NCT02197598
- Testing
- nalmefene
- Where
- 3 sites in Germany
- Volunteers
- 45 people
- Sponsor
- H. Lundbeck A/S
Hepatic Failure, Liver Failure
Cardiox Liver Function Test Pivotal Trial
Performance evaluation of LFT Dye Monitor System using ICG - plasma disappearance rate value (PDR) to assess liver function in normal patients as well as in patients with mild to severe hepatic impairment compared to manual Serum…
- Trial name
- LFT-0002 (NCT02552901)
- Testing
- 0.1 mg/kg ICG Dose, 0.5 mg/kg ICG dose
- Where
- United States
- Volunteers
- healthy volunteers welcome
- Sponsor
- Cardiox Corporation
Postoperative Graft Function
Hepatic Vein Flow During Orthotopic Liver Transplantation as Predictive Factor for Postoperative Graft Function
Hepatic vein flow (HVF) assessment using transesophageal echocardiography (TEE) has a potential to predict postoperative graft function in orthotopic liver transplant (OLT).
- Trial name
- NCT03814031
- Testing
- NO internvention
- Where
- United States
- Volunteers
- 97 people
- Sponsor
- Henry Ford Health System
Minimal Hepatic Encephalopathy
Study of Lactulose in Children With Chronic Liver Disease
Pediatric patients with chronic liver disease may have Minimal Hepatic Encephalopathy(MHE)which can cause changes in behavior,intelligence and neurological function.By utilizing cognitive and developmental testing we will…
- Trial name
- MHE (NCT00811434)
- Testing
- Lactulose
- Where
- United States
- Volunteers
- 16 people
- Sponsor
- Indiana University
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