Clinical trials: Hepatic Impairment
Mild Hepatic Encephalopathy
AST-120 Used to Treat Mild Hepatic Encephalopathy
The purpose of this study is to determine whether AST-120 is safe and effective in the treatment of mild hepatic encephalopathy.
- Trial name
- ASTUTE (NCT00867698)
- Testing
- AST-120
- Where
- 38 sites in United States
- Volunteers
- 148 people
- Sponsor
- Ocera Therapeutics
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.)
Renal Insufficiency, Hepatic Insufficiency
Collection of Data of Ceftobiprole Treated Patients: Comparison of Patients With and Without Certain Diseases
In this observational study, data from patients treated with the antibiotic ceftobiprole in the past will be collected. The sponsor of the study is Correvio International Sárl, based in Switzerland.
- Conditions
- Renal Insufficiency, Hepatic Insufficiency, Immunosuppression
- Trial name
- RETRACE (NCT04170309)
- Testing
- Ceftobiprole medocaril
- Where
- 18 sites in France, Germany and 2 more
- Volunteers
- 428 people
- Sponsor
- Advanz Pharma
Hepatic Impairment, Healthy
A Study to Evaluate the Effect of Hepatic Impairment on Lazertinib (JNJ-73841937)
The purpose of this study is to evaluate the pharmacokinetics (PK) of a single oral dose of lazertinib in participants with impaired hepatic function when compared with healthy participants with normal hepatic function, under fed…
- Trial name
- NCT05112952
- Testing
- Lazertinib
- Where
- 2 sites in Germany
- Volunteers
- 16 people, healthy volunteers welcome
- Sponsor
- Janssen Research & Development, LLC
Complement Mediated Primary or Secondary Glomerular Diseases
Investigation of Pharmacokinetics,Safety,and Pharmacodynamics of HRS-5965 in Subjects With Hepatic Impairment
The study is being conducted to compare the pharmacokinetics, safety, and pharmacodynamics of HRS-5965 in subjects with mild to moderate hepatic impairment and normal hepatic function.
- Trial name
- NCT06674915
- Testing
- HRS-5965 capsules
- Where
- China
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Chengdu Suncadia Medicine Co., Ltd.
Healthy Volunteer Study, Hepatic Impairment
Study of Bemnifosbuvir/Ruzasvir as a Fixed-dose Combination in Subjects With Normal or Severely Impaired Renal or Hepatic Function
To Assess the Effect of Severe Hepatic or Renal Impairment on the Pharmacokinetics of Bemnifosbuvir/Ruzasvir After a Single Dose
- Conditions
- Healthy Volunteer Study, Hepatic Impairment, Renal Impairment
- Trial name
- NCT06911320
- Testing
- Bemnifosbuvir (BEM)/Ruzasvir (RZR) as a fixed-dose combination
- Where
- 2 sites in United States
- Volunteers
- 28 people, healthy volunteers welcome
- Sponsor
- Atea Pharmaceuticals, Inc.
Liver Dysfunction, Liver Insufficiency
An Investigational Study of Experimental Medication BMS-986231 Given in Participants With Different Levels of Liver Function
This is an investigational study of experimental Medication BMS-986231 given to participants with weakened or damaged liver function.
- Conditions
- Liver Dysfunction, Liver Insufficiency, Hepatic Failure, Myocardial Failure
- Trial name
- NCT03515980
- Testing
- BMS-986231
- Where
- 4 sites in Hungary, Poland
- Volunteers
- 76 people, healthy volunteers welcome
- Sponsor
- Bristol-Myers Squibb
Endometriosis Related Pain, Overactive Bladder
Study on the Safety of BAY1817080, How it is Tolerated and the Way the Body Absorbs, Distributes and Gets Rid of the Study Drug in Participants With Impaired Liver Function or Normal Liver Function
BAY1817080 is currently under clinical development to treat pain related to unexplained chronic cough or chronic cough not affected by a treatment (refractory and/or unexplained chronic cough, RUCC), or a condition where the…
- Conditions
- Endometriosis Related Pain, Overactive Bladder, Diabetic Neuropathic Pain, Refractory or Unexplained Chronic Cough
- Trial name
- NCT04454424
- Testing
- BAY1817080, Midazolam
- Where
- 2 sites in United States
- Volunteers
- 37 people
- Sponsor
- Bayer
Hepatic Impairment
Study to Evaluate the Pharmacokinetics of Telotristat Ethyl in Subjects With Severe Hepatic Impairment
This study is designed to evaluate the effect of severe hepatic impairment on the pharmacokinetics (PK) of telotristat ethyl (TE) ( LP-778902 active moiety, metabolite), following administration of a single dose of TE 250 mg (1 x…
- Trial name
- NCT03423446
- Testing
- Telotristat Ethyl
- Where
- 3 sites in United States
- Volunteers
- 16 people, healthy volunteers welcome
- Sponsor
- Lexicon Pharmaceuticals
Hepatic Impairment
A Study of Mezigdomide in Healthy Participants and Participants With Hepatic Impairment
The aim of this study is to measure the concentration levels of mezigdomide in the blood of participants with mild, moderate, and severe hepatic impairment, and in matched healthy control participants with normal hepatic function.
- Trial name
- NCT05707390
- Testing
- Mezigdomide
- Where
- 3 sites in United States
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- Bristol-Myers Squibb
Diffuse Large B-Cell Lymphoma, High-grade B-cell Lymphoma
A Study to Evaluate the Pharmacokinetics and Safety of Loncastuximab Tesirine in Participants With Relapsed or Refractory Diffuse Large B-cell Lymphoma or High-grade B-cell Lymphoma With Hepatic Impairment (LOTIS-10)
The primary objective of this study is to determine the recommended dosing regimen of loncastuximab tesirine in diffuse large B-cell lymphoma (DLBCL) or high-grade B-cell lymphoma (HGBCL) participants with moderate and severe…
- Trial name
- NCT05660395
- Testing
- Loncastuximab Tesirine
- Where
- 14 sites in United States, Brazil and 2 more
- Volunteers
- 5 people
- Sponsor
- ADC Therapeutics S.A.
Healthy Volunteer
A Study of Danoprevir in Healthy Volunteers And Patients With Hepatic Impairment
This non-randomized, multi-center, open-label study will evaluate the pharmacokinetics and the safety and tolerability of danoprevir (RO5190591) and ritonavir in healthy volunteers and patients with mild, moderate or severe…
- Trial name
- NCT01185873
- Testing
- danoprevir, ritonavir
- Where
- 5 sites in United States, Czechia and 1 more
- Volunteers
- 81 people, healthy volunteers welcome
- Sponsor
- Hoffmann-La Roche
Primary Biliary Cholangitis
Real-World Data Study to Evaluate the Effectiveness of OCA on Hepatic Outcomes in PBC Patients
This is an observational, retrospective cohort study of patients with primary biliary cholangitis (PBC) who failed ursodeoxycholic acid (UDCA) treatment, using a real-world data source, the Komodo Health United States (US) claims…
- Trial name
- HEROES PBC (NCT05292872)
- Where
- United States
- Volunteers
- 4,577 people
- Sponsor
- Intercept Pharmaceuticals
Hepatic Insufficiency
Hepatic Impaired Subjects Compared to Healthy Subjects Receiving Multi-dose BMS-650032
The purpose of this study is to assess the effects of hepatic impairment on the multiple dose pharmacokinetics of BMS-650032.
- Trial name
- NCT01019070
- Testing
- BMS-650032
- Where
- 2 sites in United States
- Volunteers
- 28 people, healthy volunteers welcome
- Sponsor
- Bristol-Myers Squibb
Hepatic Impairment, Hepatic Function
A Pharmacokinetic and Safety Study of E7080 in Subjects With Mild (10 mg), Moderate (10 mg), and Severe Hepatic Impairment (5 mg) and Normal Hepatic Function (10 mg)
This is a multi-center, open-label, non-randomized, single-dose, sequential-cohort study in subjects with varying degrees of hepatic impairment, classified according to the Child-Pugh system, who will be matched with normal…
- Trial name
- NCT02421042
- Testing
- Lenvatinib
- Where
- 5 sites in United States
- Volunteers
- 14 people, healthy volunteers welcome
- Sponsor
- Eisai Inc.
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
Hepatic Impairment
An Open-label, Non-randomized, Parallel Group Study in Subjects With Mild and Moderate Hepatic Insufficiency and Healthy Volunteers
Multi-center, non-randomized, open-label, single-dose, parallel group study to determine the effect of impaired hepatic function on the PK of deferiprone and its 3-O-glucuronide metabolite following a single oral dose of 33mg/kg…
- Trial name
- NCT01767103
- Testing
- Ferriprox®
- Where
- 2 sites in United States
- Volunteers
- 21 people, healthy volunteers welcome
- Sponsor
- ApoPharma
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
Hepatic Impairment
Fruquintinib Hepatic Impairment Study
An Open-label, Phase 1 Study to Assess the Effect of Hepatic Impairment on the Pharmacokinetics of Fruquintinib
- Trial name
- NCT05216367
- Testing
- Fruquintinib
- Where
- 2 sites in United States
- Volunteers
- 16 people, healthy volunteers welcome
- Sponsor
- Hutchmed
Hepatic Impairment
A Study to Evaluate the Effect of Mild, Moderate, and Severe Hepatic Impairment on Pharmacokinetics of Sitravatinib
A Phase 1, Multicenter, Open-Label Study to Evaluate the Effect of Mild, Moderate, and Severe Hepatic Impairment on the Single-Dose Pharmacokinetics of Sitravatinib
- Trial name
- NCT04772612
- Testing
- sitravatinib
- Where
- 5 sites in United States
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- Mirati Therapeutics Inc.