Clinical trials: Liver Diseases
Hepatic Encephalopathy
Efficacy and Safety of AXA1665 in Cirrhotic Subjects With Prior Overt Hepatic Encephalopathy
This is a global study to compare the effects of AXA1665, an orally active mixture of amino acids, compared to placebo, on cognitive and physical function, as well as the safety and tolerability of AXA1665.
- Trial name
- EMMPOWER (NCT04816916)
- Testing
- AXA1665
- Where
- 40 sites in United States, Canada and 5 more
- Volunteers
- 12 people
- Sponsor
- Axcella Health, Inc
Chronic Hepatitis B
The Tolerability and Pharmacokinetics Clinical Trial of Metacavir Enteric-coated Capsules in Healthy Adult Volunteers
Conduct in Chinese healthy adult subjects:1.To observe the safety and tolerability of multiple-dose oral administration of different doses of PNA;2.By measuring the changing drug concentration in the plasma and urine after a…
- Trial name
- NCT03180333
- Testing
- PNA
- Where
- China
- Volunteers
- 16 people, healthy volunteers welcome
- Sponsor
- Guangzhou Yipinhong Pharmaceutical CO.,LTD
Hepatitis B, Chronic
A Study of the Oral Farnesoid X Receptor Modulator EYP001a to Assess Its Safety and Anti-viral Effect in Chronic Hepatitis B Patients in Combination With Pegylated Interferon alpha2a Alone and With Entecavir
This is a multi centre, two parallel arm, randomized, open-label, Phase 2a experimental study of oral Farnesoid X Receptor (FXR) modulator EYP001a to assess its safety and anti-viral effect when administered to non-treated…
- Trial name
- NCT04365933
- Testing
- EYP001a, Entecavir, Pegylated interferon alpha2a
- Where
- 6 sites in Hong Kong, South Korea and 1 more
- Volunteers
- 20 people
- Sponsor
- Enyo Pharma
Hepatitis B
A Study of the Immune Response to Heplisav in Healthy Older Adults
This study will investigate the response of the immune system to a hepatitis B (HB) vaccine in healthy adults 50 to 70 years of age. This study is partially funded by the National Institute of Allergy and Infectious Diseases.
- Trial name
- NCT01999699
- Testing
- HEPLISAV
- Where
- United States
- Volunteers
- 25 people, healthy volunteers welcome
- Sponsor
- Dynavax Technologies Corporation
Chronic Obstructive Pulmonary Disease, Alpha1-antitrypsin Deficiency
Stage 1 Study of ARALAST NP and GLASSIA in A1PI Deficiency
The purpose of this study is to conduct a pilot study to evaluate the safety and efficacy of weekly administration of Alpha1-Proteinase Inhibitor (A1PI) augmentation therapy in subjects with A1PI deficiency and emphysema/ chronic…
- Trial name
- NCT02722304
- Testing
- ARALAST NP 60 mg/kg, ARALAST NP 120 mg/kg, GLASSIA 60 mg/kg
- Where
- 17 sites in United States, Australia and 1 more
- Volunteers
- 7 people
- Sponsor
- Baxalta now part of Shire
Chronic Hepatitis B
Safety and Efficacy Study of NVR 3-778 in Healthy Volunteers and Hepatitis B Patients
This Phase 1 trial will assess the dose-related safety and PK profile of different doses of NVR 3-778, first in healthy volunteer subjects (part I) and subsequently in patients with chronic hepatitis B (part II).
- Trial name
- NCT02112799
- Testing
- NVR 3-778, Pegasys
- Where
- 2 sites in New Zealand
- Volunteers
- 55 people, healthy volunteers welcome
- Sponsor
- Novira Therapeutics, Inc.
Immunotherapy, Cancer
Observational Basket Trial to Collect Tissue to Develop and Train a Live Tumor Diagnostic Platform (ELEPHAS-02)
The primary objective of this study is to develop and train the Elephas live tumor diagnostic platform and determine the ex-vivo accuracy of the Elephas Score using in-vivo RECIST 1.1 as the reference method
- Conditions
- Immunotherapy, Cancer, Bladder Cancer, Urothelial Carcinoma Bladder
- Trial name
- ELEPHAS-02 (NCT05520099)
- Testing
- Core Needle Biopsy, Forceps Biopsy, Punch Biopsy
- Where
- 12 sites in United States
- Volunteers
- 416 people
- Sponsor
- Elephas
Multiple Myeloma
A Safety and Efficacy of Pomalyst® Capsules Under the Actual Use in All Patients Who Are Treated With Pomalyst at a Dose of 1 mg, 2 mg, 3 mg, or 4 mg
1. Planned enrollment period One year (The planned number of patients to be enrolled is set to 400 patients.) Since all patients who are prescribed with Pomalyst are registered in RevMate®, enrollment using the Registration Form…
- Trial name
- NCT02921828
- Where
- 2 sites in United States, Japan
- Volunteers
- 1,149 people
- Sponsor
- Celgene
Drug-induced Liver Injury
Rechallenge, Potential Drug Induced Liver Injury (Kaiser)
Drug re-administration or rechallenge should be avoided after drug-induced liver injury (DILI) to avoid recurrent and fatal injury. Rechallenge outcomes vary considerably by drug and patient subjects.
- Trial name
- NCT01584765
- Testing
- Prescription drugs with known hepatotoxicity
- Volunteers
- 1 people
- Sponsor
- GlaxoSmithKline
Breast Neoplasms
Special Investigation For Patients With Renal And/Or Hepatic Disorders On Aromasin
The objective of this surveillance is to collect information about 1) adverse drug reaction not expected from the LPD (unknown adverse drug reaction), 2) the incidence of adverse drug reactions in this surveillance, and 3)factors…
- Trial name
- NCT00932165
- Testing
- Exemestane
- Volunteers
- 451 people
- Sponsor
- Pfizer
Hepatic Impairment, Healthy Volunteers
A Study to Evaluate ASP0367 in Participants With Mild/Moderate Hepatic Impairment Compared to Participants With Normal Hepatic Function
The purpose of this study is to evaluate the effect of ASP0367 in participants with mild and moderate hepatic impairment compared to healthy participants with normal hepatic function.
- Trial name
- NCT04942964
- Testing
- Bocidelpar
- Where
- 3 sites in United States
- Volunteers
- 25 people, healthy volunteers welcome
- Sponsor
- Astellas Pharma Global Development, Inc.
Chronic Delta Hepatitis
Titrating-Dose of Lonafarnib in Combination With Ritonavir
A phase 2, open-label study to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamic activity of titrating-dose lonafarnib/ritonavir in patients chronically infected with hepatitis delta virus (HDV)
- Trial name
- LOWR-4 (NCT02527707)
- Testing
- lonafarnib, Ritonavir
- Volunteers
- 15 people
- Sponsor
- EIT Pharma, Inc.
Lennox Gastaut Syndrome, Dravet Syndrome
Assessment of Potential for Chronic Liver Injury in Participants Treated With Epidiolex (Cannabidiol) Oral Solution
This study will monitor for potential chronic liver injury and liver fibrosis, in participants treated with cannabidiol oral solution.
- Conditions
- Lennox Gastaut Syndrome, Dravet Syndrome, Tuberous Sclerosis Complex
- Trial name
- NCT05044819
- Testing
- Cannabidiol
- Where
- 26 sites in United States
- Volunteers
- 154 people
- Sponsor
- Jazz Pharmaceuticals
Chronic Hepatitis B
Evaluate Efficacy, Safety and PK of Adefovir Dipivoxil Liquid Suspension in Patients With Chronic Hepatitis B
This is a multi-center phase 3, open-label, parallel-group study designed to evaluate the efficacy, safety and pharmacokinetics of adefovir dipivoxil liquid suspension in patients with chronic hepatitis B and varying degrees of…
- Trial name
- NCT00071201
- Testing
- Adefovir Dipivoxil for oral suspension, 2 mg/mL
- Where
- United States
- Volunteers
- 48 people
- Sponsor
- Gilead Sciences
Hepatic Insufficiency, Healthy
Clinical Pharmacology of FYU-981 (Subjects With Hepatic Insufficiency)
The purpose of this study is to assess the pharmacokinetics, pharmacodynamics and safety after single oral administration of FYU-981 to subjects with hepatic insufficiency and with normal hepatic function.
- Trial name
- NCT03306667
- Testing
- FYU-981
- Where
- Japan
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Mochida Pharmaceutical Company, Ltd.
Primary Biliary Cholangitis
Study of E6011 in Japanese Subjects With Primary Biliary Cholangitis Inadequately Responding to Ursodeoxycholic Acid
This study is a placebo-controlled, randomized, double-blind, multicenter, parallel-group comparison study in primary biliary cholangitis participants inadequately responding to ursodeoxycholic acid.
- Trial name
- NCT03092765
- Testing
- E6011
- Where
- 46 sites in Japan
- Volunteers
- 29 people
- Sponsor
- EA Pharma Co., Ltd.
Hepatic Insufficiency
The Influence of Hepatic Insufficiency on the Pharmacokinetics of Elbasvir (MK-8742) (MK-8742-009)
The purpose of this study is to evaluate the pharmacokinetics (PK) profile of elbasvir (MK-8742) after a single dose to participants with mild, moderate, or severe hepatic insufficiency compared with healthy controls.
- Trial name
- NCT01797536
- Testing
- Elbasvir
- Where
- 2 sites in United States
- Volunteers
- 31 people, healthy volunteers welcome
- Sponsor
- Merck Sharp & Dohme LLC
Chronic HCV Infection
Ledipasvir/Sofosbuvir Fixed-Dose Combination + Ribavirin in Subjects With Chronic HCV With Advanced Liver Disease or Post-Liver Transplant
This study will evaluate ledipasvir/sofosbuvir (LDV/SOF) fixed-dose combination (FDC) plus ribavirin (RBV) in participants with advanced liver disease or posttransplant and chronic genotype 1 or 4 hepatitis C virus (HCV)…
- Trial name
- NCT01938430
- Testing
- LDV/SOF, RBV
- Where
- 30 sites in United States
- Volunteers
- 339 people
- Sponsor
- Gilead Sciences
Liver Cancer
Feasibility of a Minimally Invasive Image-Guided Surgery System for Hepatic Procedures
This study was designed in two phases: Phase I is designed to confirm that the surgeon is able to perform accurate liver surface registration including standard liver features used as landmarks during a scheduled laparoscopic…
- Trial name
- NCT01286428
- Where
- United States
- Volunteers
- 30 people
- Sponsor
- Pathfinder Therapeutics
Chronic Hepatitis B Infection
Efficacy and Safety of Ricovir® in Maintaining Durability of Viral Response in Chronic Hepatitis B Patients Who Have Been Treated With Viread® and Have Undetectable HBV DNA in Serum
This is a phase IV, open label, historical controlled comparative study to evaluate the efficacy and safety of Ricovir® in maintaining durability of viral response in CHB patients who have been treated with Viread® and have…
- Trial name
- NCT05355467
- Testing
- Tenofovir disoproxil fumarate, Historical Data
- Where
- Taiwan
- Volunteers
- 40 people
- Sponsor
- Mylan (Taiwan) Ltd
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