Clinical trials: Patients With Impaired Hepatic Function
Solid Tumours
Study to Assess the Blood Levels and Safety of AZD9291 in Patients With Advanced Solid Tumours and Normal Liver Function or Mild or Moderate Liver Impairment
This is a 2-part study in patients with advanced solid tumours. Part A will investigate the pharmacokinetics (PK) of AZD9291 in patients with mild or moderate hepatic impairment compared to patients with normal hepatic function…
- Trial name
- NCT02161770
- Testing
- AZD9291 tablet dosing, Pharmacokinetic sampling - AZD9291, Pharmacokinetic sampling - AZ5140 and AZ7550
- Where
- 19 sites in United States, Belgium and 4 more
- Volunteers
- 30 people
- Sponsor
- AstraZeneca
Myelofibrosis
Determine Pacritinib Pharmacokinetics in Impaired Hepatic Patients and Healthy Subjects
This is an open-label, parallel-group, single-dose study of the PK and safety of 400 mg pacritinib administered orally to patients with stable chronic liver disease and healthy control subjects.
- Trial name
- NCT02765724
- Testing
- Pacritinib
- Where
- 2 sites in Germany, Moldova
- Volunteers
- 28 people, healthy volunteers welcome
- Sponsor
- CTI BioPharma
Hepatic Impairment
A Pharmacokinetic Study of Abiraterone Acetate in Patients With Severe Hepatic Impairment Compared to Patients With Normal Hepatic Function
The purpose of this study is to evaluate systemic exposure of abiraterone acetate in adult male patients with severe hepatic impairment and is being conducted to collect information that will support clinical dosing…
- Trial name
- NCT01516047
- Testing
- Cohort 1, Cohort 2
- Where
- 3 sites in United States
- Volunteers
- 16 people
- Sponsor
- Janssen Research & Development, LLC
Liver Cirrhosis
The Tolerability，Safety，PK/PD Study of rhTPO in the Patients With Liver Function Impairment
The purpose of this study is to evaluate the tolerability, safety, pharmacokinetics and pharmacodynamics of recombinant human thrombopoietin in the patients with different degree of liver function impairment according Child- Pugh…
- Trial name
- NCT03673215
- Testing
- Recombinant human thrombopoietin
- Where
- China
- Volunteers
- 58 people
- Sponsor
- Shenyang Sunshine Pharmaceutical Co., LTD.
Carcinoma, Hepatocellular
A Study of Brivanib (BMS-582664) in Patients With Liver Cancer and Mild, Moderate or Severe Liver Dysfunction
The primary purpose of this protocol is to determine the effect of BMS-582664 on patients with hepatocellular carcinoma with varying levels of hepatic impairment
- Trial name
- NCT00437424
- Testing
- Brivanib
- Where
- 5 sites in United States, Spain
- Volunteers
- 24 people
- Sponsor
- Bristol-Myers Squibb
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
Hepatic Insufficiency
Pharmacokinetics, Pharmacodynamics, Safety and Tolerability of Dabigatran Etexilate in Patients With Moderate Hepatic Impairment Compared to Subjects With Normal Hepatic Function
Assessment of the effect of moderate liver impairment (Child-Pugh classification B) on the pharmacokinetics and pharmacodynamics of dabigatran after oral administration of dabigatran etexilate.
- Trial name
- NCT02170571
- Testing
- Dabigatran etexilate
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Boehringer Ingelheim
Type 2 Diabetes Mellitus, Liver Dysfunction
Pharmacokinetic and Pharmacodynamic Study of Glufast Tablets 10mg(Mitiglinide)
This clinical trial is designed to assess the effect of hepatic impairment on the pharmacokinetic and pharmacodynamic of glufast tablets 10 mg.
- Trial name
- NCT04349696
- Testing
- Mitiglinide
- Where
- 2 sites in Taiwan
- Volunteers
- 16 people
- Sponsor
- Orient Europharma Co., Ltd.
Hepatic Cirrhosis, Alcoholism
Pharmacokinetics and Safety of Single Subcutaneous Pasireotide (SOM230) in Subjects With Varying Degrees of Hepatic Function
The purpose of this study is to evaluate the effect of varying degrees of hepatic function (Child-Pugh classification) on the pharmacokinetics and safety of pasireotide s.c. in subjects.
- Trial name
- NCT00698464
- Testing
- Pasireotide
- Where
- 4 sites in United States, Belgium and 2 more
- Volunteers
- 34 people
- Sponsor
- Novartis Pharmaceuticals
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
Improved Glycemic Control in Patients With Type 2 Diabetes
A Trial of HR17031 Injection With Hepatic Insufficiency
This study used a single-dose, open design to compare the pharmacokinetics of subjects with mild and moderate liver impairment and subjects with normal liver function.
- Trial name
- NCT05151705
- Testing
- HR17031 injection
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Jiangsu HengRui Medicine Co., Ltd.
Solid Tumor, Adult, Impaired Liver Function
Oral Docetaxel in Patients With Normal or Impaired Liver Function
This is an open label, single centre pharmacological and safety study to define the safety and pharmacokinetics of ModraDoc006/r in a weekly dosing schedule in patients with impaired liver function who might have benefit from a…
- Trial name
- NCT05084456
- Testing
- ModraDoc006/r
- Where
- Netherlands
- Sponsor
- Modra Pharmaceuticals
Hepatic Impairment
Assessment of the Single Dose Pharmacokinetics and Tolerability of Sativex in Patients With Impaired Hepatic Function and Healthy Patients
A Phase I open-label study to evaluate the pharmacokinetics (what the body does to a drug), safety and tolerability of a single dose of Sativex (containing 10.8 mg tetrahydrocannabinol [THC] and 10 mg cannabidiol [CBD]) in…
- Trial name
- NCT01887301
- Testing
- Sativex
- Where
- 2 sites in United States
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- Jazz Pharmaceuticals
Solid Tumours
Study to Assess the Blood Levels and Safety of Olaparib in Patients With Advanced Solid Tumours and Normal Liver Function or Mild or Moderate Liver Impairment
This is a 2-part study in patients with advanced solid tumours. Part A will investigate the PK of olaparib in patients with mild or moderate hepatic impairment compared to patients with normal hepatic function; Part B will allow…
- Trial name
- NCT01894243
- Testing
- Olaparib tablet dosing
- Where
- 12 sites in Czechia, France and 3 more
- Volunteers
- 31 people
- Sponsor
- AstraZeneca
Solid Tumors, Hepatic Impairment
Pharmacokinetics (PK) of TKI258 in Cancer Patients With Normal and Impaired Hepatic Function
This is a multi-center, open label study to assess pharmacokinetics (PK) of TKI258 at single-dose and steady state in adult cancer patients either with mild, moderate or severe hepatic impairment or with normal hepatic function.
- Trial name
- NCT01443481
- Testing
- Dovitinib
- Where
- 12 sites in United States, Belgium and 4 more
- Volunteers
- 38 people
- Sponsor
- Novartis Pharmaceuticals
Impaired Hepatic Function
Evaluating Patients With Impaired Hepatic Function
This is a Phase I, Open-Label study evaluating the PK of S-1 components and their metabolites in patients with advanced solid tumors and varying degrees of hepatic function defined by the NCI classification for hepatic…
- Trial name
- NCT00398424
- Testing
- S-1/Cisplatin
- Where
- 6 sites in United States
- Volunteers
- 24 people
- Sponsor
- Taiho Oncology, Inc.
Ovarian Neoplasms, Neoplasms
Pharmacokinetic and Safety Study of Niraparib With Normal or Moderate Hepatic Impairment Patients
Niraparib (Zejula®)is extensively metabolized and eliminated primarily by hepatic and renal pathways. The purpose of this study is to evaluate pharmacokinetics and safety of niraparib in patients with moderate hepatic impairment…
- Conditions
- Ovarian Neoplasms, Neoplasms, Solid Tumor, Hepatic Impairment
- Trial name
- NCT03359850
- Testing
- Niraparib
- Where
- 5 sites in United States
- Volunteers
- 17 people
- Sponsor
- Tesaro, Inc.
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
Breast Cancer
A Study to Learn About the Relationship Between Hepatic Impairment and Myelosuppression (Decreased Bone Marrow Function) in Breast Cancer Patients Treated With the Study Medicine Palbociclib (Pal-bow-sai-klib)
The purpose of this study is to evaluate incidence of grade 4 neutropenia in patients who have hepatic impairment and use the study medicine Palbociclib.This study is seeking participants: - treated with the study medicine…
- Trial name
- NCT05912933
- Where
- United States
- Volunteers
- 1,342 people
- Sponsor
- Pfizer
Liver Disease
A Phase 1 Study to Compare the PK and Safety of Naproxcinod in Hepatic Impaired Patients and Matching Healthy Subjects
This is an open-label study that will compare the pharmacokinetic and safety effects of naproxcinod in hepatic impaired patients vs. matching healthy subjects.
- Trial name
- NCT00621881
- Testing
- naproxcinod
- Where
- United States
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- NicOx