Clinical trials: Liver Function
Hepatic Insufficiency, Hepatic Impairment
A Clinical Study of Enlicitide Decanoate in People With Liver Function Problems (MK-0616-030)
Researchers have designed a new study medicine called enlicitide decanoate as a new way to lower the amount of low-density lipoprotein cholesterol (LDL-C) in a person's blood.
- Trial name
- NCT06575959
- Testing
- Enlicitide
- Where
- 2 sites in United States
- Volunteers
- 20 people, healthy volunteers welcome
- Sponsor
- Merck Sharp & Dohme LLC
Schizophrenia
A Study Evaluating the of OPC-34712 in Subjects With Normal Hepatic Function and Hepatically Impaired Subjects
The purpose of this study is to evaluate how much of the investigational product gets into the blood stream and how long the body takes to get rid of it when given to subjects with a range of liver impairment compared to subjects…
- Trial name
- NCT01299454
- Testing
- OPC-34712
- Where
- 3 sites in United States
- Volunteers
- 45 people, healthy volunteers welcome
- Sponsor
- Otsuka Pharmaceutical Development & Commercialization, 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.
Carcinoma, Hepatocellular
Efficacy, Safety, and Pharmacokinetic of MSC2156119J in Asian Participants With Hepatocellular Carcinoma
This is an open-label, integrated, Phase 1b/2 trial to determine the recommended Phase 2 dose (RP2D) and to evaluate the efficacy, safety, and pharmacokinetic of MSC2156119J as first-line treatment versus sorafenib in subjects…
- Trial name
- NCT01988493
- Testing
- Tepotinib 300 mg, Tepotinib 500 mg, Tepotinib 1000 mg
- Where
- 43 sites in China, South Korea and 1 more
- Volunteers
- 117 people
- Sponsor
- Merck KGaA, Darmstadt, Germany
Type 2 Diabetes Mellitus, Hepatic Impairment
Pharmacokinetics, Safety, and Tolerability of Ertugliflozin (MK-8835/PF-04971729) in Participants With Hepatic Impairment and in Healthy Participants (MK-8835-014)
This is a study to assess the pharmacokinetics and safety of ertugliflozin (MK-8835, PF-04971729) in participants with hepatic impairment versus healthy participants.
- Trial name
- NCT02115347
- Testing
- Ertugliflozin 15 mg
- Volunteers
- 16 people, healthy volunteers welcome
- Sponsor
- Merck Sharp & Dohme LLC
Muscular Atrophy, Spinal
A Study to Investigate the Effect of Hepatic Impairment on the Pharmacokinetics and Safety and Tolerability of a Single Oral Dose of Risdiplam Compared to Matched Healthy Participants With Normal Hepatic Function
This is a multi-center, open-label, non-randomized, parallel-group, 2-part study to evaluate the effect of hepatic impairment on the PK and safety and tolerability of a single oral dose of risdiplam compared to matched healthy…
- Trial name
- NCT03920865
- Testing
- Risdiplam
- Where
- 3 sites in United States
- Volunteers
- 26 people, healthy volunteers welcome
- Sponsor
- Hoffmann-La Roche
Healthy, Hepatic Insufficiency
A Study of LY3502970 in Participants With Impaired and Normal Liver Function
The main purpose of this study is to measure how much of LY3502970 gets into the bloodstream and how long it takes the body to eliminate it in participants with mild, moderate and severe impaired liver function compared to…
- Trial name
- NCT05882032
- Testing
- LY3502970
- Where
- 4 sites in United States
- Volunteers
- 29 people, healthy volunteers welcome
- Sponsor
- Eli Lilly and Company
Fatty Liver
A Study of Siliphos in Adults With Non-alcoholic Steatohepatitis (NASH)
The purpose of this study is to evaluate the dietary supplement Siliphos, which comes from milk thistle, to determine whether it is safe and well-tolerated in adults who have non-alcoholic steatohepatitis (NASH).
- Trial name
- NCT00443079
- Testing
- IdB 1016 (Siliphos)
- Where
- United States
- Volunteers
- 6 people
- Sponsor
- Heather Patton
Liver Transplantation
Efficacy and Safety of Everolimus in Liver Transplant Recipients of Living Donor Liver Transplants
The purpose of this trial was to demonstrate the efficacy and safety of everolimus in combination with reduced tacrolimus, compared to tacrolimus control, in living donor liver transplant recipients.
- Trial name
- NCT01888432
- Testing
- Everolimus + reduced tacrolimus, Standard tacrolimus
- Where
- 42 sites in United States, Canada and 11 more
- Volunteers
- 285 people
- Sponsor
- Novartis Pharmaceuticals
Liver Transplantation
A Study of CellCept (Mycophenolate Mofetil) Combined With Calcineurin Inhibitors in Liver Transplant Patients.
This 2 arm study will compare the efficacy and safety of switching to CellCept combined with different regimens of reduced calcineurin inhibitors (CNI) in patients with liver transplants.
- Trial name
- NCT00717314
- Testing
- Mycophenolate mofetil, CNI (50%), CNI (≥75%)
- Where
- 11 sites in China
- Volunteers
- 87 people
- Sponsor
- Hoffmann-La Roche
NAFLD
Study of the Safety and Tolerability of AXA1957 in Adolescent Subjects With Non-Alcoholic Fatty Liver Disease (NAFLD)
This is a randomized, single blind study to determine whether AXA1957, a novel composition of amino acids, is safe and well tolerated.
- Trial name
- NCT04073407
- Testing
- AXA1957
- Where
- 4 sites in United Kingdom
- Volunteers
- 9 people
- Sponsor
- Axcella Health, Inc
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
Cancer
Liver Function Test (LFT) Elevations in Cancer Patients and Users of Tyrosine Kinase Inhibitor (TKI) Drugs
A retrospective cohort study using the LabRx medical claims database will be performed to address these objectives. The primary objective of this project is to examine the background rates of liver function test (LFT)…
- Trial name
- NCT01098500
- Testing
- Tyrosine kinase inhibitors
- Volunteers
- 3,800 people
- Sponsor
- GlaxoSmithKline
Hepatic Insufficiency, Healthy
Pharmacokinetics of Empagliflozin (BI 10773) in Patients With Impaired Liver Function
The main objective of this study is to assess the effect of mild, moderate and severe hepatic impairment on the pharmacokinetics, safety and tolerability of BI 10773 following oral administration of BI 10773 as a single dose.
- Trial name
- NCT01111318
- Testing
- BI 10773
- Where
- Romania
- Volunteers
- 36 people, healthy volunteers welcome
- Sponsor
- Boehringer Ingelheim
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
NASH - Nonalcoholic Steatohepatitis
The HepQuant SHUNT Test for Monitoring Liver Disease and Treatment Effects by Measuring Liver Function and Physiology
The HepQuant SHUNT test, which is provided as a HepQuant SHUNT Liver Diagnostic Kit, is a minimally-invasive test of liver function and physiology which has been designated by the FDA as an investigational drug/device combination…
- Trial name
- NCT03294941
- Testing
- HepQuant SHUNT Liver Diagnostic Kit
- Where
- 8 sites in United States
- Volunteers
- 17 people
- Sponsor
- HepQuant, LLC
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
Impaired Glucose Tolerance (IGT), Diabetes
Acute Effect of Exenatide on Brain Glucose Metabolism
This research study will examine brain glucose metabolism after an overnight fast to determine the effect of exenatide on brain glucose metabolism and lipid metabolism.
- Trial name
- NCT01588418
- Testing
- Exenatide
- Where
- United States
- Volunteers
- 15 people
- Sponsor
- The University of Texas Health Science Center at San Antonio
Liver Cancer, Hepatocellular Carcinoma
A Pilot Study to Assess Theragnostically Planned Liver Radiation to Optimize Radiation Therapy
The purpose of this study is to compare radiation treatment plans that are designed for patients with liver cancer. One treatment plan will be created using routine procedures and scans normally performed for radiation treatment…
- Conditions
- Liver Cancer, Hepatocellular Carcinoma, Cholangiocarcinoma
- Trial name
- NCT03338062
- Testing
- Hepatobiliary Iminodiacetic Acid (HIDA) scan
- Where
- United States
- Volunteers
- 15 people
- Sponsor
- Indiana University
Diabetic Kidney Disease
Study to Evaluate the Pharmacokinetics of Selonsertib in Participants With Normal and Impaired Hepatic Function
The primary objective of this study is to evaluate the pharmacokinetics (PK) of selonsertib in participants with impaired hepatic function relative to matched, healthy controls.
- Trial name
- NCT02509624
- Testing
- Selonsertib
- Where
- 5 sites in United States
- Volunteers
- 52 people, healthy volunteers welcome
- Sponsor
- Gilead Sciences