Clinical trials: Patients With Impaired Hepatic Function
Hepatic Impairment
Impact of Hepatic Impairment on the Pharmacokinetics of Deferasirox.
This study is to assess the pharmacokinetics of deferasirox in hepatically impaired patients compared to healthy volunteers.
- Trial name
- NCT00432627
- Testing
- Deferasirox
- Where
- Germany
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Novartis Pharmaceuticals
Impaired Liver Function
Evaluate the Safety and PK of Proellex® in Female Patients With Impaired Hepatic Function and Healthy Adults
This study will evaluate the safety and pharmacokinetics of two doses of orally administered Proellex® in female patients with impaired hepatic function and healthy volunteers with normal hepatic function.
- Trial name
- NCT00741273
- Testing
- Proellex
- Where
- 2 sites in United States
- Volunteers
- 16 people, healthy volunteers welcome
- Sponsor
- Repros Therapeutics Inc.
Hepatic Complications, Lymphoma
Temsirolimus in Treating Patients With Metastatic Solid Tumor or Lymphoma That Cannot Be Removed By Surgery Who Have Different Levels of Liver Function
This phase I trial is studying the side effects and best dose of temsirolimus in treating patients with metastatic solid tumor or lymphoma that cannot be removed by surgery who have different levels of liver function.
- Conditions
- Hepatic Complications, Lymphoma, Unspecified Adult Solid Tumor, Protocol Specific
- Trial name
- NCT00275093
- Testing
- temsirolimus, laboratory biomarker analysis, pharmacological study
- Where
- United States
- Volunteers
- 130 people
- Sponsor
- National Cancer Institute (NCI)
Patients With Impaired Hepatic Function
Pharmacokinetics Study in Patients With Impaired Hepatic Function
The objective of this study is to compare and evaluate the pharmacokinetics of ASP015K in patients with impaired hepatic function and subjects with normal hepatic function.
- Trial name
- NCT02586194
- Testing
- ASP015K
- Where
- 6 sites in Japan
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Astellas Pharma Inc
End Stage Liver Disease, Impaired Renal Function
CNI-free de Novo Protocol in Patients Undergoing Liver Transplantation With Renal Impairment
Background: Patients undergoing liver transplantation with preexisting renal dysfunction are prone to further renal impairment with the early postoperative use of Calcineurin-inhibitors.
- Trial name
- PATRON07 (NCT00604357)
- Testing
- anti-CD 25 mAb, Sirolimus, MMF
- Where
- Germany
- Volunteers
- 27 people
- Sponsor
- University of Regensburg
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
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.
Hepatocellular Carcinoma
A Study to Evaluate the Safety, Tolerability and Efficacy of Cabozantinib in Patients With Hepatocellular Carcinoma and Impaired Liver Function
This is an prospective, interventional, non-randomized multicenter phase II study to evaluate the safety, tolerability and efficacy of Cabozantinib as a second-line therapy (after one prior systemic therapy) in patients with…
- Trial name
- CaboCHILD (NCT04454762)
- Testing
- Cabozantinib
- Where
- Germany
- Volunteers
- 20 people
- Sponsor
- Johannes Gutenberg University Mainz
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