Clinical trials: Hepatic Impairment
Transthyretin Amyloidosis, Transthyretin Amyloidosis With Cardiomyopathy
Long-term Safety of Eplontersen Treated aTTR Patients and in Liver Transplant and Severely Hepatic Impaired Subpopulations
The aim of this observational cohort study is to characterise use of eplontersen in patients with prior liver transplant or with pre-existing severe hepatic impairment, as well as to assess long-term safety among all new users of…
- Conditions
- Transthyretin Amyloidosis, Transthyretin Amyloidosis With Cardiomyopathy, Transthyretin Amyloidosis With Polyneuropathy
- Trial name
- sTTRing (NCT07654855)
- Testing
- None ( observational study )
- Where
- 6 sites in United States, Canada and 4 more
- Volunteers
- 320 people
- Sponsor
- AstraZeneca
Hepatic Impairment
Single-Dose PK and Safety Study of GBT440 in Subjects With Hepatic Impairment
A Phase 1, multiple center, nonrandomized, open-label, parallel group study of a single oral dose of GBT440 administered in subjects with mild (Child-Pugh A), moderate (Child-Pugh B), or severe (Child-Pugh C) hepatic impairment…
- Trial name
- NCT03114540
- Testing
- GBT440
- Where
- 2 sites in United States
- Volunteers
- 29 people, healthy volunteers welcome
- Sponsor
- Pfizer
Hepatic Impairment, Healthy Volunteers
A Study of HDM1002 in Subjects With And Without Varying Degrees Of Hepatic Impairement
The current study is proposed to evaluate whether there is any clinically meaningful effect of hepatic impairment on the plasma Pharmacokinetic (PK) of HDM1002
- Trial name
- NCT06985615
- Testing
- Single dose of HDM1002 on Day 1
- Where
- China
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd.
Hepatic Impairment, Healthy Volunteers
STUDY OF PF-06882961 IN PARTICIPANTS WITH AND WITHOUT VARYING DEGREES OF HEPATIC IMPAIREMENT
The current study is proposed to evaluate whether there is any clinically meaningful effect of hepatic impairment on the plasma Pharmacokinetic (PK) of PF-06882961
- Trial name
- NCT04604496
- Testing
- PF-06882961 20MG
- Where
- 2 sites in United States
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Pfizer
Healthy Participants, Hepatic Impairment
Comparative PK Assessment Study of Casdatifan in Moderate Hepatically Impaired Participants Versus Matched Participants With Normal Hepatic Function
The purpose of the study is to compare the single dose PK of casdatifan between participants with moderate hepatic impairment (HI) and healthy matched control participants with normal hepatic function.
- Trial name
- NCT07751250
- Testing
- Casdatifan
- Where
- United States
- Volunteers
- 16 people, healthy volunteers welcome
- Sponsor
- Arcus Biosciences, Inc.
Prevention of Thromboembolic Events, Atrial Fibrillation
A Study to Learn How the Study Treatment Asundexian Moves Into, Through and Out of the Body, How it Works, How Safe it is, and How it Affects the Body in Participants With Mild or Moderate Reduction of Liver Function Compared to Participants With Normal Liver Function
Researchers are looking for a better way to prevent the formation of blood clots in people who have or have had: an irregular and often rapid heartbeat a blocked blood flow to the heart a blocked or reduced blood flow to a part…
- Conditions
- Prevention of Thromboembolic Events, Atrial Fibrillation, Acute Myocardial Infarction, Non-cardioembolic Ischemic Stroke
- Trial name
- NCT05419635
- Testing
- Asundexian (BAY2433334)
- Where
- Germany
- Volunteers
- 27 people, healthy volunteers welcome
- Sponsor
- Bayer
Hepatic Insufficiency & Healthy Subjects
Safety and Pharmacokinetics of Zanubrutinib (BGB-3111) in Healthy Subjects and Those With Impaired Liver Function
This study is designed to evaluate the safety and pharmacokinetics of zanubrutinib in subjects with impaired liver function in comparison with healthy subjects
- Trial name
- NCT03465059
- Testing
- Zanubrutinib
- Where
- 2 sites in United States
- Volunteers
- 29 people
- Sponsor
- BeiGene
Neoplasms
A Study of The Impact of Severe Hepatic Impairment on the Pharmacokinetics and Safety of Vemurafenib in BRAF V600 Mutation-Positive Cancer Participants
This open-label, Phase I study will evaluate the impact of severe hepatic impairment on the pharmacokinetics and safety of vemurafenib in participants with BRAF V600 mutation positive cancer.
- Trial name
- NCT01767623
- Testing
- Vemurafenib
- Where
- 8 sites in United States, Australia and 5 more
- Volunteers
- 8 people
- Sponsor
- Hoffmann-La Roche
Hepatic Impairment
A Study to Assess the Pharmacokinetics of CC-90001 in Subjects With Mild, Moderate, and Severe Hepatic Impairment Compared With Healthy Subjects
This is a multicenter, open-label study to assess the PK of a single 200 mg oral dose of CC-90001 in subjects with mild, moderate, and severe hepatic impairment, and in matched healthy control subjects with normal hepatic…
- Trial name
- NCT03742882
- Testing
- CC-90001
- Where
- 4 sites in United States
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- Celgene
Cystic Fibrosis
Pharmacokinetics and Safety Assessment of VX-121/Tezacaftor/Deutivacaftor in Participants With Moderate Hepatic Impairment
The purpose of this study is to evaluate the pharmacokinetics (PK) and safety of VX-121/tezacaftor/deutivacaftor (VX-121/TEZ/D-IVA) in participants with moderate hepatic impairment and in matched healthy participants.
- Trial name
- NCT05437120
- Testing
- VX-121/TEZ/D-IVA
- Where
- 2 sites in United States
- Volunteers
- 16 people, healthy volunteers welcome
- Sponsor
- Vertex Pharmaceuticals Incorporated
NASH
A Study of EDP-305 in Subjects With Mild and Moderate Hepatic Impairment Compared With Normal Healthy Volunteers
This is a study to characterize the pharmacokinetics as well as safety and tolerability of a single oral dose of EDP-305 in subjects with mild and moderate hepatic impairment compared to matched healthy subjects.
- Trial name
- NCT03207425
- Testing
- EDP 305
- Where
- 3 sites in United States, Czechia and 1 more
- Volunteers
- 29 people, healthy volunteers welcome
- Sponsor
- Enanta Pharmaceuticals, Inc
Hepatic Insufficiency
Clinical Trial of FCN-437c Capsule in Patients With Hepatic Insufficiency
To evaluate and compare the safety and efficacy of FCN-437c in subjects with mild and moderate liver impairment and healthy subjects, and to provide a basis for clinical medication in patients with liver impairment.
- Trial name
- NCT06620731
- Testing
- FCN-437c capsule
- Where
- China
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Ahon Pharmaceutical Co., Ltd.
Healthy, Hepatic Impairment
Study to Assess the Pharmacokinetics of Cabozantinib (XL184) in Hepatic Impaired Adult Subjects
The main objective of this study is to compare the pharmacokinetics (PK) of a single oral 75 mg dose of cabozantinib in hepatic impaired adult subjects to healthy adult subjects.
- Trial name
- NCT01493869
- Testing
- cabozantinib
- Where
- United States
- Volunteers
- 26 people, healthy volunteers welcome
- Sponsor
- Exelixis
Hepatic Impairment
Impact of Severe Hepatic Impairment on Pharmacokinetics of Cenicriviroc and Its Metabolites
The objective of this study is to assess the pharmacokinetics (PK), safety, and tolerability profiles of cenicriviroc (CVC) and its metabolites (M-I and M-II) in participants with severely impaired hepatic function compared with…
- Trial name
- NCT03376841
- Testing
- Cenicriviroc
- Where
- 2 sites in United States
- Volunteers
- 16 people, healthy volunteers welcome
- Sponsor
- Allergan
Hepatic Impairment and Healthy Female
Pharmacokinetics of VC005 Tablets in Subjects With Hepatic Impairment and Normal Hepatic Function
This study is a Phase I, single-dose, open-label trial designed to evaluate the pharmacokinetics and safety of a single oral dose of 25 mg VC005 tablets in participants with mild and moderate hepatic impairment compared to…
- Trial name
- NCT07551557
- Testing
- VC005 Tablets
- Where
- China
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Jiangsu vcare pharmaceutical technology co., LTD
Hepatitis B Virus
Study to Evaluate the Pharmacokinetics of Tenofovir Alafenamide (TAF) in Adults With Normal Hepatic Function and Adults With Severe Hepatic Impairment
The primary objective of this study is to evaluate the single-dose pharmacokinetics of tenofovir alafenamide (TAF) and its metabolite tenofovir (TFV) in participants with normal hepatic function and in participants with severe…
- Trial name
- NCT02296853
- Testing
- TAF
- Where
- 5 sites in United States, Germany and 1 more
- Volunteers
- 20 people, healthy volunteers welcome
- Sponsor
- Gilead Sciences
Hepatic Insufficiency
Evaluation Of Hepatic Impairment On AG-013736 Pharmacokinetics
This study will evaluate the effects of mild and moderate impairment of hepatic function on the single-dose pharmacokinetics, safety and tolerability of AG-013736.
- Trial name
- NCT00692341
- Testing
- AG-013736
- Where
- 2 sites in United States
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Pfizer
Hepatic Impairment
Pharmacokinetic Properties of Lorcaserin in Subjects With Hepatic Impairment
The purpose of this study is to evaluate and establish whether lorcaserin dose adjustment is required in patients with mild or moderate hepatic impairment.
- Trial name
- NCT00828932
- Testing
- Lorcaserin
- Where
- United States
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Eisai Inc.
Primary Central Nervous System Lymphoma (PCNSL)
A Study to Investigate the Pharmacokinetics of Tirabrutinib in Participants With Mild, Moderate, and Severe Hepatic Impairment Compared to Healthy Participants
A study to investigate the pharmacokinetics of tirabrutinib in participants with mild, moderate, and severe hepatic impairment compared to healthy participants
- Trial name
- NCT07198087
- Testing
- Tirabrutinib
- Where
- 3 sites in United States
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- Ono Pharmaceutical Co., Ltd.
Chronic Kidney Disease, Hepatic Impairment
A Study to Learn About How BAY 3283142 Moves Into, Through, and Out of the Body After a Single Dose in Participants With Reduced Liver Function Compared to Participants With Normal Liver Function
Researchers are looking for a better way to treat people who have chronic kidney disease (CKD). CKD is a condition in which the kidneys' ability to work properly gradually decreases over time.
- Trial name
- NCT06402721
- Testing
- BAY3283142
- Where
- United States
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Bayer