Clinical trials: Hepatic and Hepatobiliary Disorders
Metabolic Dysfunction-associated Steatotic Liver Disease
Digital Pathology and AI for Liver Outcomes in MASLD
The aim of this multi-center, retrospective epidemiologic study is to confirm the prognostic performance of the Digital Pathology (DP) FibroNest Phenotypic Fibrosis Composite Score (Ph-FCS), derived from standard digital…
- Trial name
- DPAILO-1 (NCT06344364)
- Testing
- Digital Pathology FibroNest Phenotypic Fibrosis Composite Score (Ph-FCS)
- Where
- 3 sites in Hong Kong, Spain
- Volunteers
- 1,241 people
- Sponsor
- PharmaNest, Inc
Liver Disease, Hyponatremia
Study to Compare Conivaptan in Subjects With Mild & Moderate Liver Impairment Versus Subjects With Normal Liver Function
A study to compare a 48-hour continuous infusion of conivaptan in subjects with mild and moderate liver impairment versus subjects with normal liver function
- Trial name
- NCT00851227
- Testing
- conivaptan hydrochloride
- Where
- United States
- Volunteers
- 26 people, healthy volunteers welcome
- Sponsor
- Cumberland Pharmaceuticals
Non-alcoholic Fatty Liver Disease
Safety and Efficacy of HL Tablet in Non-alcoholic Fatty Liver Disease Patients
This study evaluates the safety and efficacy of HL tablet on reducing hepatic fat in non-alcoholic fatty liver disease patients. The patients are allocated to three groups; low dose, high dose, and placebo control group.
- Trial name
- NCT02491905
- Testing
- HL tablet
- Where
- South Korea
- Volunteers
- 69 people
- Sponsor
- Huons Co., Ltd.
Liver Fibrosis Due to NASH
Simtuzumab (SIM, GS-6624) in the Treatment of Cirrhosis Due to NASH
The primary objective of this study is to evaluate the safety and efficacy of SIM (formerly referred to as GS-6624) in adults with compensated cirrhosis due to Non-Alcoholic Steatohepatitis (NASH).
- Trial name
- NASH (NCT01672879)
- Testing
- SIM
- Where
- 59 sites in United States, Canada and 6 more
- Volunteers
- 259 people
- Sponsor
- Gilead Sciences
MASLD - Metabolic Dysfunction-Associated Steatotic Liver Disease, NAFLD - Non-Alcoholic Fatty Liver Disease
Development of a Quantifiable Ultrasound Biomarker for Hepatic Steatosis
The research study is considering a non-invasive way to measure the percentage of fat in the liver using ultrasound. This could help detect early signs of a very common condition called metabolic dysfunction-associated steatotic…
- Trial name
- LYNX (NCT07270601)
- Testing
- Verasonics NXT Data Acquisition System, Philips EPIQ Elite, EchoSense FibroScan
- Where
- United States
- Volunteers
- 110 people, healthy volunteers welcome
- Sponsor
- ContextVision AB
Diabetes Mellitus, Type 2
A Study to Test How a New Long-acting Insulin (Insulin Icodec) Works in the Body of People With Liver Disease
Participants will receive one insulin icodec dose, which will be administered in the morning of the day of dosing. The study will last for about 8 weeks.
- Trial name
- NCT04597697
- Testing
- Insulin icodec
- Where
- 2 sites in Czechia, Slovakia
- Volunteers
- 25 people
- Sponsor
- Novo Nordisk A/S
Hepatic Impairment, Liver Disease
Elafibranor Pharmacokinetic Parameters in Hepatic Impaired Patients
This study is being conducted in order to assess the need for dose adjustment for elafibranor in patients with hepatic impairment.
- Conditions
- Hepatic Impairment, Liver Disease, Pharmacokinetics
- Trial name
- NCT03765671
- Testing
- Elafibranor
- Where
- 2 sites in United States
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- Genfit
Hepatic Disease, Renal Disease
Assess Safety and Performance of the Kronos Electrocautery Device for Electrocautery Procedures Following Coaxial Biopsy Procedures
The primary objective for this study is to assess safety and performance of the Kronos Electrocautery Device for electrocautery procedures following coaxial biopsy procedures on areas that include, but are not limited to, liver…
- Trial name
- NCT05593211
- Testing
- Kronos Electrocautery Device
- Where
- United States
- Volunteers
- 31 people, healthy volunteers welcome
- Sponsor
- Single Pass Inc
Hepatitis C, Chronic, Non-Alcoholic Fatty Liver Disease
Intra-Individual Reproducibility of the Non-Invasive Assessment of the Portal Circulation
HepQuant tests are new liver tests that are being developed to accurately measure liver function with sensitivity and specificity while being safe and non-invasive.
- Trial name
- Repro (NCT01579162)
- Testing
- Cholate-24-13C (IND 65121) & Cholate-2,2,4,4-d4 (IND 65123)
- Where
- United States
- Volunteers
- 48 people, healthy volunteers welcome
- Sponsor
- HepQuant, LLC
Nonalcoholic Steatohepatitis (NASH), Primary Sclerosing Cholangitis (PSC)
Pharmacokinetics and Pharmacodynamics of Cilofexor in Adults With Normal and Impaired Hepatic Function
The primary objective of this study is to evaluate the single-dose pharmacokinetics of cilofexor in adults with impaired hepatic function relative to matched, healthy controls with normal hepatic function.
- Trial name
- NCT02808312
- Testing
- Cilofexor
- Where
- 5 sites in United States, New Zealand
- Volunteers
- 57 people, healthy volunteers welcome
- Sponsor
- Gilead Sciences
Hepatic Impairment, Healthy Participants
A STUDY TO COMPARE THE PHARMACOKINETICS OF PF-06835919 IN PARTICIPANTS WITH AND WITHOUT HEPATIC IMPAIRMENT
The study is proposed to characterize the effect of varying degrees of hepatic impairment on the plasma PK of PF-06835919
- Trial name
- NCT04193436
- Testing
- PF-06835919 25 mg
- Where
- 3 sites in Belgium, Czechia and 1 more
- Volunteers
- 23 people, healthy volunteers welcome
- Sponsor
- Pfizer
Myelodysplastic Syndromes, Leukemia, Myelomonocytic, Chronic
A Study of Pevonedistat in People With Blood Cancers or Solid Tumors With Kidney or Liver Problems
Pevonedistat is a medicine to treat people with blood cancers or solid tumors. The main aim of the study is to learn about the levels of pevonedistat in the blood of participants with blood cancers or solid tumors, who also have…
- Conditions
- Myelodysplastic Syndromes, Leukemia, Myelomonocytic, Chronic, Leukemia, Myeloid, Acute, Renal Insufficiency
- Trial name
- NCT03814005
- Testing
- Azacitidine, Pevonedistat
- Where
- 8 sites in United States, Spain
- Volunteers
- 17 people
- Sponsor
- Takeda
Hepatic Cirrhosis, Nonalcoholic Steatohepatitis
Clearance of NRL972 in Patients With Cirrhosis, Nonalcoholic Steatohepatitis (NASH) and in Healthy Volunteers
The study was conducted to describe and compare the plasma pharmacokinetics of NRL972 administered after a standard meal and while fasted in patients with hepatic cirrhosis (Child-Turcotte-Pugh [CTP] class A-C), NASH, young and…
- Trial name
- NCT00856869
- Testing
- NRL972
- Where
- Bulgaria
- Volunteers
- 52 people, healthy volunteers welcome
- Sponsor
- Norgine
Liver Disease
Study to Assess the Safety, Tolerability, and Pharmacodynamics of RTA 402 in Patients With Hepatic Dysfunction
This study assesses the safety and tolerability of RTA 402 in patients with liver disease.
- Trial name
- NCT00550849
- Testing
- RTA 402
- Where
- United States
- Volunteers
- 16 people
- Sponsor
- Biogen
Hepatic Cirrhosis
Clearance of NRL972 in Patients With Cirrhosis and in Healthy Volunteers
A study in healthy volunteers and patients with liver cirrhosis to assess the effects of age, gender, and stable liver disease on the clearance of cholyl-lysyl-fluorescein (NRL972)
- Trial name
- NCT00856713
- Testing
- NRL972
- Where
- Bulgaria
- Volunteers
- 72 people, healthy volunteers welcome
- Sponsor
- Norgine
End Stage Liver DIsease
Mobilization of Stem Cells With G-CSF and Mozobil in Patients With End Stage Liver Disease
A phase I trial to study the safety of mobilization of stem cells with G-CSF and Mozobil in patients with chronic liver disease.
- Trial name
- NCT01711073
- Testing
- Mobilization with G-CSF and Mozobil
- Where
- United States
- Volunteers
- 15 people
- Sponsor
- Proteonomix, Inc.
Non-Alcoholic Steatohepatitis (NASH)
Phase 1 Study to Evaluate Safety of GR-MD-02 in Subjects With Non-Alcoholic Steatohepatitis (NASH) and Advanced Fibrosis
The primary objective of this study is to characterize the safety, tolerability and dose-limiting toxicities (DLTs) for GR-MD-02 when administered intravenously to subjects with biopsy-proven NASH with advanced liver fibrosis.
- Trial name
- NCT01899859
- Testing
- GR-MD-02
- Where
- United States
- Volunteers
- 31 people
- Sponsor
- Galectin Therapeutics Inc.
Hepatic and Hepatobiliary Disorders
Essentiale® Paste in Patients With Gastrointestinal Symptoms in Acute or Chronic Liver Diseases
Primary Objective: To assess safety of Phosphatidylcholine paste 600 mg (ESSENTIALE® paste) oral 3 times a day for 12 weeks in patients with gastrointestinal symptoms in acute and chronic liver diseases.
- Trial name
- EPLID (NCT02517385)
- Testing
- Phosphatidylcholine
- Where
- Russia
- Volunteers
- 147 people
- Sponsor
- Sanofi
Non-alcoholic Fatty Liver Disease
A Study of Efimosfermin Alfa in Adults With Hepatic Impairment
This study is designed to study the pharmacokinetic (PK) and safety profiles of a single dose of efimosfermin alfa in participants with varying degrees of Hepatic Impairment (HI) (assessed by Child-Pugh score) due to steatotic…
- Trial name
- NCT07358546
- Testing
- Efimosfermin alfa
- Where
- 5 sites in United States
- Volunteers
- 32 people
- Sponsor
- GlaxoSmithKline
Chronic Liver Disease, Hepatic Encephalopathy
Effect of Probiotics in Treatment of Minimal Hepatic Encephalopathy (MHE) and Health Related Quality of Life
This study is a randomized, open, parallel group, active comparator, single center trial. Objectives of the study are hereby given below: To study the health related quality of life (HRQOL) in patients with chronic liver disease.
- Trial name
- MHE (NCT01008293)
- Testing
- VSL#3, Lactulose
- Where
- India
- Volunteers
- 120 people
- Sponsor
- CD Pharma India Pvt. Ltd.