Clinical trials: Patients With Impaired Hepatic Function
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
Hepatic Cancer
Liver Resection for Patients With Hepatocellular Carcinoma and Impaired Liver Function
Hepatic dysfunction limits the therapeutic options for hepatocellular carcinoma (HCC), which is closely associated with patient prognosis.
- Trial name
- NCT06245785
- Testing
- transarterial chemoembolisation
- Where
- 2 sites in China
- Volunteers
- 2,200 people
- Sponsor
- Tang-Du Hospital
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.
Cirrhosis, Hepatic Encephalopathy
Brain Imaging in Patients With Chronic Liver Disease and Functional Impairment.
Hepatic encephalopathy (HE) is a frequent complication of chronic liver disease (cirrhosis) and involves a wide spectrum of problems from mild impairment of reaction times in driving and operating machinery through to…
- Trial name
- NCT00305591
- Testing
- l-ornithine l-aspartate
- Where
- United Kingdom
- Volunteers
- 50 people, healthy volunteers welcome
- Sponsor
- Imperial College London
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
Hypercholesterolemia
Pharmacokinetic and Tolerability of Alirocumab SAR236553 (REGN727) in Patients With Hepatic Impairment and in Healthy Subjects
Primary Objective: Study the effect of mild or moderate hepatic impairment on the pharmacokinetics of alirocumab SAR236553 (REGN727).
- Trial name
- NCT01670734
- Testing
- alirocumab SAR236553 (REGN727)
- Where
- 2 sites in France, Moldova
- Volunteers
- 25 people, healthy volunteers welcome
- Sponsor
- Sanofi
Cholangiocarcinoma, Cirrhosis
Radiation Therapy in Treating Patients With Hepatocellular Carcinoma, Cholangiocarcinoma, or Liver Metastasis Who Have Impaired Liver Function
This phase I trial studies the side effects and the best dose of radiation therapy in treating patients with hepatocellular carcinoma, cholangiocarcinoma, or cancer that has spread from the original (primary) tumor to the liver…
- Conditions
- Cholangiocarcinoma, Cirrhosis, Hepatocellular Carcinoma, Metastatic Malignant Neoplasm in the Liver
- Trial name
- NCT02626312
- Testing
- Laboratory Biomarker Analysis, Magnetic Resonance Imaging, Radiation Therapy
- Where
- United States
- Volunteers
- 36 people
- Sponsor
- M.D. Anderson Cancer Center
Healthy, Liver Diseases
Single Dose of BI 1744 CL in Patients With Mild and Moderate Hepatic Impairment Compared to Subjects With Normal Hepatic Function
The main objective of this study was to investigate the influence of mild and moderate liver impairment on the pharmacokinetics, safety and selected pharmacodynamic parameters of BI 1744 CL in comparison to a control group with…
- Trial name
- NCT02171832
- Testing
- BI 1744 CL, low dose, BI 1744 CL, high dose
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- Boehringer Ingelheim
Healthy Volunteers, Hepatic Impairment of Moderate Child Pugh Category
HI Study to Assess and Compare the Pharmacokinetic Parameters of MD1003 in Hepatic Impaired Patients and Healthy Subjects
This is a Phase 1, multicentric, open-label,two arms to assess and compare the effect of single oral administration of MD1003 on the pharmacokinetic parameters in hepatic impaired patients and healthy subjects with normal hepatic…
- Trial name
- NCT04252417
- Testing
- MD1003
- Where
- 3 sites in France, Hungary
- Volunteers
- 15 people, healthy volunteers welcome
- Sponsor
- MedDay Pharmaceuticals SA
Neoplasms
Rucaparib Hepatic Impairment Study in Patients With a Solid Tumor
Phase 1, open-label, parallel group, PK, safety and tolerability study in patients with an advanced solid tumor and either normal hepatic function (Group 1, n = 8) or moderate hepatic impairment (Group 2, n = 8) according to the…
- Trial name
- NCT03521037
- Testing
- Rucaparib camsylate
- Where
- 6 sites in Poland, Slovakia and 1 more
- Volunteers
- 16 people
- Sponsor
- pharmaand GmbH
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
Diabetes Mellitus, Type 2
A Pharmacokinetic Study of MK-3102 in Participants With Impaired Hepatic Function (MK-3102-031)
This study will investigate and compare the pharmacokinetics of a single 25-mg dose of MK-3102 in participants with moderate hepatic impairment and matched healthy participants.
- Trial name
- NCT01767688
- Testing
- MK-3102
- Volunteers
- 16 people, healthy volunteers welcome
- Sponsor
- Merck Sharp & Dohme LLC