Clinical trials: Hepatic
Hepatic Impairment
Pharmacokinetics (PK) of 20 mg Teduglutide in Participants With Moderately Impaired Hepatic Function Compared to Healthy Participants
This is a study to compare the pharmacokinetic profile of teduglutide in healthy participants with normal hepatic function with participants who have moderate hepatic impairment.
- Trial name
- NCT00819468
- Testing
- Teduglutide
- Where
- United States
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Shire
Viral Hepatitis B, Viral Hepatitis D
Replicor Compassionate Access Program
The goal of this compassionate access program is to provide early access to REP 2139-Mg for patients with HBV mono-infection or HBV / HDV co-infection who either have advanced (decompensated) cirrhosis or who have failed to…
- Conditions
- Viral Hepatitis B, Viral Hepatitis D, Cirrhosis, Liver, Decompensated Cirrhosis
- Trial name
- RCAP (NCT05683548)
- Testing
- REP 2139-Mg, Tenofovir Disoproxil Fumarate, Pegylated interferon alpha2a
- Where
- 13 sites in Austria, France and 3 more
- Sponsor
- Replicor Inc.
Solid Tumors, Hematologic Malignancies
Study of the Pharmacokinetics and Safety of Carfilzomib in Patients With Advanced Malignancies and Hepatic Impairment
The purpose of this study is to compare the safety and efficacy of carfilzomib, including measuring the amount of the study drug in the blood at certain times following dosing.
- Conditions
- Solid Tumors, Hematologic Malignancies, Hepatic Impairment
- Trial name
- NCT01949545
- Testing
- Carfilzomib
- Where
- 11 sites in United States, France and 2 more
- Volunteers
- 46 people
- Sponsor
- Amgen
Non-alcoholic Fatty Liver Disease, Fatty Liver, Nonalcoholic
Knockdown of HSD17B13 mRNA, Pharmacokinetics, Safety, and Tolerability, of AZD7503 in Non-Alcoholic Fatty Liver Disease
This is a two-part study. In Part A, eligible participants will undergo a baseline diagnostic liver biopsy to determine non-alcoholic fatty liver disease (NAFLD) Activity Score (NAS) and fibrosis stage, but will not receive study…
- Conditions
- Non-alcoholic Fatty Liver Disease, Fatty Liver, Nonalcoholic, NAFLD, Nonalcoholic Fatty Liver Disease
- Trial name
- NCT05560607
- Testing
- AZD7503 Intervention
- Where
- United States
- Volunteers
- 19 people
- Sponsor
- AstraZeneca
Hepatic Impairment
A Study to Evaluate the Pharmacokinetics of BMS-986141 in Participants With Hepatic Impairment Compared to Healthy Participants
An oral dose of BMS-986141 administered in Hepatic Impairment and Healthy Participants to evaluate pharmacokinetics in this patient population.
- Trial name
- NCT02985632
- Testing
- BMS-986141
- Where
- 3 sites in United States
- Volunteers
- healthy volunteers welcome
- Sponsor
- Bristol-Myers Squibb
Renal Insufficiency, Kidney Diseases
A Study to Evaluate the Pharmacokinetics and Safety of INCB054707 in Participants With Normal Hepatic Function and Participants With Hepatic Impairment
This is a multicenter, open-label, parallel-group study to evaluate INCB054707 in participants with varying levels of renal function or impairment.
- Trial name
- NCT05624710
- Testing
- INCB054707
- Where
- 4 sites in United States, Germany
- Volunteers
- 25 people, healthy volunteers welcome
- Sponsor
- Incyte Corporation
Impaired Hepatic Function, Healthy
Study of ALXN2050 in Participants With Hepatic Impairment
This study will investigate the impact of impaired hepatic function (IHF) on the plasma pharmacokinetics of ALXN2050 in order to provide dosing recommendations for future indications in individuals with varying degrees of IHF.
- Trial name
- NCT05259085
- Testing
- ALXN2050
- Where
- 2 sites in United States
- Volunteers
- 26 people
- Sponsor
- Alexion Pharmaceuticals, Inc.
Hepatic Cirrhosis
Multi-national Cirrhosis Study to Characterise the Association Between the Pharmacokinetics of NRL972 and Disease Severity.
This is a multi-centre, multi-national, open study to assess the pharmacokinetics of NRL972 in patients with hepatic cirrhosis CTP-classes A, B, and C (histologically confirmed by liver biopsy).
- Trial name
- NCT00794482
- Testing
- NRL972
- Where
- Germany
- Volunteers
- 1,200 people
- Sponsor
- Norgine
Hepatocellular Carcinoma
Non-Interventional Registry Study to Evaluate the Effectiveness of TheraSphere® in the Treatment of Hepatocellular Carcinoma (HCC)
The purpose of this registry study is to gather effectiveness, QoL, safety and procedural information on TheraSphere® for the treatment of participants with Hepatocellular Carcinoma (HCC), Intrahepatic Cholangiocarcinoma (iCC)…
- Trial name
- PROACTIF (NCT04069468)
- Testing
- TheraSphere
- Where
- 37 sites in France
- Volunteers
- 1,247 people
- Sponsor
- Boston Scientific Corporation
Hepatic Impairment, Healthy
Study of Lumacaftor in Combination With Ivacaftor in Subjects With Moderate Hepatic Impairment and Healthy Subjects
This study is designed to evaluate the pharmacokinetics (PK) and safety of multiple doses of lumacaftor in combination with ivacaftor in subjects with moderate hepatic impairment.
- Trial name
- NCT01888393
- Testing
- lumacaftor 200 mg q12h + ivacaftor 250 mg q12h
- Where
- 2 sites in Czechia, Slovakia
- Volunteers
- 23 people, healthy volunteers welcome
- Sponsor
- Vertex Pharmaceuticals Incorporated
Hepatic Impairment, Healthy Volunteers
A Research Study Looking at How a Single Dose of the Medicine Cagrilintide Works in Participants With Reduced Liver Function and in Healthy Participants With Normal Liver Function and How Cagrilintide is Absorbed and Used by the Body
The study is divided into two parts - Part A and Part B. Cagrilintide in combination with semaglutide, is under development for weight management.
- Trial name
- NCT05564104
- Testing
- Cagrilintide
- Where
- 4 sites in Czechia, Germany and 1 more
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- Novo Nordisk A/S
Healthy, Liver Diseases
A Study to (1) Compare How BI 456906 is Taken up in the Body of Healthy People and People With Liver Problems and (2) Find Out How People With Overweight and Obesity, With and Without Liver Problems, Tolerate Different Doses of BI 456906
This study is open to adults who have different levels of liver problems and adults who are healthy. People with or without overweight or obesity can take part. This study has 2 parts.
- Conditions
- Healthy, Liver Diseases, Obesity
- Trial name
- NCT05296733
- Testing
- BI 456906
- Where
- 13 sites in United States, Germany and 4 more
- Volunteers
- 82 people
- Sponsor
- Boehringer Ingelheim
Liver Diseases
A Study to Learn How the Body Processes the Study Medicine Called Osivelotor (PF-07940367) in People With Loss of Liver Function
The purpose of this study is to understand how Osivelotor is processed in people with loss of liver function. This study is seeking participants that are: stable loss of liver function with mild or moderate severity none of…
- Trial name
- NCT06340347
- Testing
- Osivelotor
- Where
- 3 sites in United States
- Volunteers
- 8 people
- Sponsor
- Pfizer
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
A Study to Investigate the Effect of Impaired Hepatic Function on the Pharmacokinetics of Entrectinib in Volunteers With Different Levels of Hepatic Function
This is a non-randomized, open-label, one treatment, four group, parallel group study to investigate the effect of impaired hepatic function on the pharmacokinetics of entrectinib in participants with different levels of hepatic…
- Trial name
- NCT04226833
- Testing
- entrectinib
- Where
- 3 sites in Czechia, Hungary and 1 more
- Volunteers
- 38 people, healthy volunteers welcome
- Sponsor
- Hoffmann-La Roche
Hepatic Impairment
A Clinical Trial of the Study Medicine (Called Fosmanogepix) in Participants With Varying Degrees of Hepatic Function.
The primary purpose of this open-label study is to characterize the plasma pharmacokinetics (PK) of manogepix (active moiety of fosmanogepix) in participants with varying degrees of hepatic function following administration of a…
- Trial name
- NCT05582187
- Testing
- Fosmanogepix
- Where
- 2 sites in United States
- Volunteers
- 28 people, healthy volunteers welcome
- Sponsor
- Basilea Pharmaceutica
Hepatic Impairment
A Study to Evaluate the Pharmacokinetics and Safety of DBPR108 in Subjects With Hepatic Impairment
This is an open-label, single-dose study to evaluate the pharmacokinetics and safety of DBPR108 in subjects with mild or moderate hepatic impairment (HI) compared to the matched control subjects with normal hepatic function.
- Trial name
- NCT04859426
- Testing
- DBPR108 tablets
- Where
- China
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- CSPC ZhongQi Pharmaceutical Technology Co., Ltd.
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 Impairment
Study to Investigate the Effect of Hepatic Impairment on the Pharmacokinetics, Safety, and Tolerability of AZD0780
This study will evaluate the pharmacokinetics (PK), safety, and tolerability of a single oral dose of AZD0780 with moderate and possibly mild hepatic impairment in comparison to a matched healthy control group.
- Trial name
- NCT06576765
- Testing
- AZD0780
- Where
- 3 sites in United States
- Volunteers
- 16 people, healthy volunteers welcome
- Sponsor
- AstraZeneca
Hepatic Insufficiency
The Influence of Hepatic Insufficiency on the Pharmacokinetics of Elbasvir (MK-8742) (MK-8742-009)
The purpose of this study is to evaluate the pharmacokinetics (PK) profile of elbasvir (MK-8742) after a single dose to participants with mild, moderate, or severe hepatic insufficiency compared with healthy controls.
- Trial name
- NCT01797536
- Testing
- Elbasvir
- Where
- 2 sites in United States
- Volunteers
- 31 people, healthy volunteers welcome
- Sponsor
- Merck Sharp & Dohme LLC