Clinical trials: Hepatic
Erythropoietic Protoporphyria (EPP)
Study to Evaluate Efficacy, Safety, and Tolerability of MT-7117 in Subjects With Erythropoietic Protoporphyria
The purpose of this study is to investigate the efficacy and safety of MT-7117 on sunlight exposure duration without symptoms and tolerance in subjects with EPP.
- Trial name
- NCT03520036
- Testing
- MT-7117 low dose, MT-7117 high dose
- Where
- 9 sites in United States
- Volunteers
- 102 people
- Sponsor
- Tanabe Pharma America, Inc.
Liver Failure
Pharmacokinetics of LCP-Tacro in Stable Liver Transplant Patients
A three sequence, open-label, multi-center, prospective, study in stable liver transplant patients to assess and compare the pharmacokinetics (Cmax, C24, and AUC), and safety of LCP-Tacro (tacrolimus) tablets versus Prograf…
- Trial name
- NCT00608244
- Testing
- LCP Tacro, Prograf
- Where
- United States
- Volunteers
- 59 people
- Sponsor
- Veloxis Pharmaceuticals
Hepatic Impairment
PK and Safety of Midostaurin in Subjects With Impaired Hepatic Function and Subjects With Normal Hepatic Function
The purpose of this international study was to assess the effect of varying degrees of impaired hepatic function compared to a normal hepatic function (Child-Pugh classification) on the pharmacokinetics and safety of midostaurin.
- Trial name
- NCT01429337
- Testing
- Midostaurin
- Where
- 7 sites in United States, Belgium and 4 more
- Volunteers
- 43 people, healthy volunteers welcome
- Sponsor
- Novartis Pharmaceuticals
Hepatic Impairment, Healthy Volunteers
A Study to Assess the Drug Levels of Repotrectinib in Healthy Participants and Participants With Moderate and Severe Hepatic Impairment
The purpose of this study is to assess the drug levels of a single oral dose of repotrectinib in participants with moderate and severe HI, and in healthy matched control participants with normal hepatic function.
- Trial name
- NCT06352528
- Testing
- Repotrectinib
- Where
- 3 sites in United States
- Volunteers
- 18 people, healthy volunteers welcome
- Sponsor
- Bristol-Myers Squibb
Cancer
A Dose Escalation and Cohort-Expansion Study of Oral eFT508 in Subjects With Advanced Solid Tumors
This clinical trial is a Phase 1-2, open-label, sequential-group, dose-escalation and cohort-expansion study evaluating the safety, pharmacokinetics, pharmacodynamics, and antitumor activity of daily oral administration of eFT508.
- Trial name
- NCT02605083
- Testing
- eFT508
- Where
- 4 sites in United States
- Volunteers
- 66 people
- Sponsor
- Effector Therapeutics
Kidney Failure, Liver Failure, Chronic
Custodiol-N Solution Compared With Custodiol Solution in Organ Transplantation (Kidney, Liver and Pancreas)
Synopsis Title of Study A prospective, randomized, single blind multicentre phase III study on organ preservation with Custodiol-N compared with Custodiol solution in organ transplantation (kidney, liver and pancreas) Protocol…
- Conditions
- Kidney Failure, Liver Failure, Chronic, Kidney-Pancreas Failure
- Trial name
- NCT03627013
- Testing
- Custodiol-N Solution, Custodiol HTK Solution
- Where
- 4 sites in Austria
- Volunteers
- 362 people
- Sponsor
- Dr. F. Köhler Chemie GmbH
Hepatic Impairment, Healthy
PK Study of Sotagliflozin in Subjects With Hepatic Impairment
To evaluate the effect of mild, moderate, or severe hepatic impairment on the pharmacokinetics (PK) of a single dose of 400 mg sotagliflozin (2 x 200-mg tablets) compared with healthy, demographically-matched subjects.
- Trial name
- NCT02471274
- Testing
- sotagliflozin
- Where
- 4 sites in United States
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- Lexicon Pharmaceuticals
Cancer, Cancer of Pancreas
Study to Assess the Safety and Preliminary Efficacy of STI-1386 Oncolytic Virus in Relapsed or Refractory Solid Tumors
This is a Phase 1b study to assess the safety and tolerability of STI-1386, an oncolytic virus, in subjects with relapsed and refractory solid tumors (RRSTs).
- Conditions
- Cancer, Cancer of Pancreas, Sarcoma, Hepatic Metastasis
- Trial name
- NCT05361954
- Testing
- STI-1386
- Volunteers
- 36 people
- Sponsor
- Sorrento Therapeutics, Inc.
Pancreatectomy, Hepatic Resection
Safety and Performance of a Synthetic Tissue Sealant in Reducing Fluid Leakage in Hepatobiliary and Pancreatic Surgery
Polyganics BV (Groningen, The Netherlands), in close collaboration with University Hospital-Eppendorf (UKE) Hamburg, has developed the Sealing Device for use in hepato-pancreato-bilary (HPB) surgery to reduce leakage of fluids…
- Trial name
- SHIELDS (NCT04024956)
- Testing
- Sealing Device
- Where
- 2 sites in Germany
- Volunteers
- 80 people
- Sponsor
- Polyganics BV
Sever Aplastic Anaemia
A Trial of Hetrombopag in Healthy and Hepatic Impairment Subjects
This is a single-dose, open-label, phase I clinical study evaluating the PK of hetrombopag in subjects with mild hepatic impairment (Child-Pugh Class A), subjects with moderate hepatic impairment (Child-Pugh Class B), as well as…
- Trial name
- NCT05088642
- Testing
- Hetrombopag Olamine Tablet
- Where
- China
- Volunteers
- 24 people
- Sponsor
- Jiangsu HengRui Medicine Co., Ltd.
Acute Hepatitis, Chronic Hepatitis
Safety & Efficacy of the Extracorporeal Liver Assist Device (ELAD) System in Patients With Hepatic Insufficiency
Evaluate on how well the ELAD system works in treating people with liver failure.
- Trial name
- ELAD (NCT00771446)
- Testing
- ELAD plus standard of care treatment, Standard of care treatment
- Where
- 6 sites in United States
- Volunteers
- 18 people
- Sponsor
- Vital Therapies, Inc.
Hepatic Impairment (HI)
Pharmacokinetic Study of Vorolanib Tablets in Trial Participants With Hepatic Impairment
This is a single-center, non-randomized, open-label, parallel-group, single-dose study designed to evaluate the safety and pharmacokinetic (PK) profile of vorolanib tablets in participants with hepatic impairment.
- Trial name
- NCT07809802
- Testing
- vorolanib
- Where
- China
- Volunteers
- 36 people, healthy volunteers welcome
- Sponsor
- Betta Pharmaceuticals Co., Ltd.
Hepatic Impairment
A Pharmacokinetic Study of Omaveloxolone in Subjects With Hepatic Impairment and Normal Hepatic Function
This study will examine the pharmacokinetics (PK) of omaveloxolone following a single oral dose of omaveloxolone in subjects with mild, moderate, or severe hepatic impairment compared to healthy subjects with normal hepatic…
- Trial name
- NCT03902002
- Testing
- Omaveloxolone 50 mg capsules
- Where
- 3 sites in United States
- Volunteers
- 48 people, healthy volunteers welcome
- Sponsor
- Biogen
Hepatic Impairment, Healthy Participants
An Investigational Study of SHR6390 in Participants With Mild to Moderate Liver Impairment and Healthy Participants
The purpose of this study is to investigate SHR6390 in participants with different levels of liver function
- Trial name
- NCT04631575
- Testing
- SHR6390
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Jiangsu HengRui Medicine Co., Ltd.
Attention Deficit Hyperactivity Disorder (ADHD), Binge-Eating Disorder Disorder
Study of the What the Body Does to the Drug in Subjects With Mild, Moderate, and Severe Liver Dysfunction
Study of the what the body does to the drug in subjects with mild, moderate, and sever liver dysfunction (not working properly)
- Trial name
- NCT02795637
- Testing
- dasotraline
- Where
- 5 sites in United States
- Volunteers
- 44 people, healthy volunteers welcome
- Sponsor
- Sumitomo Pharma America, Inc.
Worsening Chronic Heart Failure, Diabetic Nephropathy
A Study to Learn How Finerenone (BAY94-8862) Moves Into, Through and Out of the Body, How it Affects the Body, and How Safe it is in Adult Participants With Different Degrees of Reduced Liver Function and in Healthy Participants With Similar Age, Weight and Gender Distribution
Researchers are looking for a better way to treat people who have worsening of chronic heart failure, a long-term condition where the heart does not pump blood as well as it should, as well as to treat patients who have diabetic…
- Trial name
- NCT04881994
- Testing
- Finerenone (BAY94-8862)
- Where
- Germany
- Volunteers
- 27 people, healthy volunteers welcome
- Sponsor
- Bayer
Hepatic Impairment, Healthy
An Open-label, Single-dose, Intravenous Administration Study of ONO-2745/CNS 7056 in Subjects With Chronic Hepatic Impairment
To evaluate and compare the pharmacokinetics and safety of ONO-2745/CNS 7056 in subjects with the hepatic impairment and matched healthy subjects.
- Trial name
- NCT01790607
- Testing
- ONO-2745 /CNS 7056
- Where
- 3 sites in United States
- Volunteers
- 20 people, healthy volunteers welcome
- Sponsor
- Ono Pharma USA Inc
Diabetes, Diabetes Mellitus, Type 2
Investigating the Pharmacokinetics, Safety and Tolerability After a Single Subcutaneous Injection of Semaglutide in Subjects With Mild, Moderate or Severe Hepatic Impairment Compared to Subjects With Normal Hepatic Function
This trial is conducted in Europe. The aim of this trial is to investigate the pharmacokinetics (the exposure of the trial drug in the body), safety and tolerability after a single injection of semaglutide in subjects with mild…
- Conditions
- Diabetes, Diabetes Mellitus, Type 2, Hepatic Impaired
- Trial name
- NCT02210871
- Testing
- semaglutide
- Where
- 4 sites in Poland, Slovakia
- Volunteers
- 44 people
- Sponsor
- Novo Nordisk A/S
Liver Dysfunction, Critical Illness
Hepa Wash Treatment of Patients With Hepatic Dysfunction in Intensive Care Units
Patients with hepatic dysfunction are known to have a high mortality rate. Hepa Wash(R) is a newly developed liver and renal support system that is based on the use of recycled albumin dialysate.
- Trial name
- HEPATICUS-2 (NCT01079104)
- Testing
- Hepa Wash, Standard Medical Therapy
- Where
- Germany
- Volunteers
- 7 people
- Sponsor
- Hepa Wash GmbH
Cirrhosis, Liver, Hepatic Cirrhosis
HCCBloodTest for Detection of Hepatocellular Carcinoma (HCC)
This is a multi-center study to prospectively gather clinically-characterized plasma samples to determine the diagnostic performance characteristics (sensitivity and specificity) of the HCCBloodTest among patients with cirrhosis…
- Conditions
- Cirrhosis, Liver, Hepatic Cirrhosis, Hepatocellular Carcinoma, Liver Cancer
- Trial name
- NCT03804593
- Where
- 2 sites in United States
- Volunteers
- 175 people
- Sponsor
- Epigenomics, Inc