Clinical trials: Liver Biopsy
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
Chronic Hepatitis C
Viral Kinetics, Interferon Stimulated Genes (ISGs) and mirRNA Among Subjects Infected With Different Hepatitis C Virus Genotypes During Therapy With Sofosbuvir and GS-5816
Background: Chronic hepatitis C is a serious liver disease. Current treatments have side effects. New drugs have been developed, but they work better in some people than others. Researchers want to learn why.
- Trial name
- NCT02468648
- Testing
- Sofosbuvir, GS-5816
- Where
- United States
- Volunteers
- 72 people
- Sponsor
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Metabolic Dysfunction-assocated Steatohepatitis/ Nonalcoholic Fatty Liver Disease
Study of TVB-2640 in Subjects With Nonalcoholic Steatohepatitis (NASH)
This is a Phase 2, multi-center, double-blind, randomized, placebo-controlled study to evaluate the safety and efficacy on TVB-2640 in subjects with non-alcoholic steatohepatitis (NASH).
- Trial name
- NCT04906421
- Testing
- TVB-2640
- Where
- 117 sites in United States, Canada and 2 more
- Volunteers
- 168 people
- Sponsor
- Sagimet Biosciences Inc.
Hepatocellular Carcinoma
Electromagnetic Tracking and Optical Imaging With ICG for Hepatic Biopsies
Background: Liver cancer is the sixth most common cancer worldwide. Diagnosing liver cancer usually requires a liver sample. Getting the best sample helps determine whether cancer is present and what kind of cancer it is.
- Trial name
- NCT04258566
- Testing
- Optical Molecular Imaging (OMI), Indocyanine Green (ICG), Electromagnetic Tracking
- Where
- United States
- Volunteers
- 7 people
- Sponsor
- National Institutes of Health Clinical Center (CC)
Liver Fibrosis, Liver Diseases
Beyond Confounders: Addressing Source of Measurement Variability and Error in Shear Wave Elastography
Chronic liver disease is a major problem in the general population and there is an unmet need to diagnose(and screen) for liver disease with using noninvasive, cost-effective and sensitive techniques.The investigators hypothesize…
- Trial name
- NCT03342560
- Testing
- Sonographic SWE measurements with 4 different ultrasound systems
- Where
- United States
- Volunteers
- 30 people
- Sponsor
- Massachusetts General Hospital
Nonalcoholic Fatty Liver Disease, Nonalcoholic Steatohepatitis With Liver Fibrosis
Metabolic Interventions to Resolve Non-alcoholic Steatohepatitis (NASH) With Fibrosis (MIRNA)
The study aims to evaluate two, orally administered, investigational agents - PF-06865571 (DGAT2 inhibitor) and the coadministration of PF-06865571 with PF-05221304 (ACC inhibitor).
- Trial name
- MIRNA (NCT04321031)
- Testing
- PF-06865571, PF-05221304
- Where
- 291 sites in United States, Bulgaria and 10 more
- Volunteers
- 256 people
- Sponsor
- Pfizer
Abnormal Liver Function
Comparison of 19g FNA and 19g FNB Needles for EUS-LB
Chronic liver disorders (CLD) are a major cause of morbidity and mortality for individuals in the US. Though serologic analysis will often lead to a conclusive diagnosis, liver biopsy remains an important method for helping to…
- Trial name
- NCT03408171
- Testing
- 19-gauge FNA needle, 19-gauge FNB needle
- Where
- United States
- Volunteers
- 40 people
- Sponsor
- Geisinger Clinic
Cystic Fibrosis, Liver Fibrosis
Elastography of the Liver in Cystic Fibrosis Patients. Diagnostic and Prognostic Aspects
The aim of the study is to find CF patients at risk for cystic fibrosis related liver disease (CFLD). Comparison of ultrasound by two modalities and biochemical markers with histological evaluation of liver biopsy if present.
- Trial name
- NCT02603666
- Testing
- Fibroscan
- Volunteers
- 130 people
- Sponsor
- Karolinska University Hospital
Non-Alcoholic Steatohepatitis
BREATHID Octanoate Breath Test With or Without Methacetin Breath Test for Correlation With Biopsy in NASH
This study's aim is to develop an algorithm for the ¹³C-Octanoate Breath Test with or without the ¹³C-Methacetin Breath Test (OBT and MBT respectively) for correlation with histological findings associated with of Non-Alcoholic…
- Trial name
- NCT02314026
- Testing
- Suspected NASH BreathID test with 13C-Octanoate, Suspected NASH Breath test with 13C Methacetin
- Where
- 11 sites in United States, Belgium and 2 more
- Volunteers
- 140 people
- Sponsor
- Meridian Bioscience, Inc.
Liver Biopsy
Prospective Analysis of Value of Contrast-enhanced Sonography During Biopsies of Focal Liver Masses
The investigators plan to compare complication and success rates between two methods of ultrasound guidance for biopsy of liver lesions, contrast-enhanced and the current protocol without contrast.
- Trial name
- NCT03040323
- Testing
- Lumason 60.7Mg Powder for Injection
- Where
- United States
- Volunteers
- 83 people
- Sponsor
- Indiana University
Non-Alcoholic Steatohepatitis
A Randomized, Double-blind Study to Assess the Safety and Efficacy of EDP-305 in Subjects With Liver-biopsy Proven NASH
A randomized, double-blind study to assess the safety and efficacy of EDP-305 in subjects with liver-biopsy proven Non-Alcoholic Steatohepatitis (NASH)
- Trial name
- NCT04378010
- Testing
- EDP-305 1.5 mg, EDP-305 2 mg
- Where
- 81 sites in United States, Argentina and 4 more
- Volunteers
- 98 people
- Sponsor
- Enanta Pharmaceuticals, Inc
Chronic Liver Disease, Non-Alcoholic Fatty Liver Disease
Ultrasound Method to Measure Fibrosis of the Liver in Children
HYPOTHESIS: The investigators hypothesize that sonoelastography (SE) provide accurate quantitative measurements that can be used to stage liver fibrosis in pediatric patients with chronic liver disease.
- Conditions
- Chronic Liver Disease, Non-Alcoholic Fatty Liver Disease, HCV Coinfection, HBV
- Trial name
- NCT02086708
- Testing
- Shear Wave sonoelastography
- Where
- United States
- Volunteers
- 24 people
- Sponsor
- Massachusetts General Hospital
Cancer Abdomen
Epione® Post-Market Clinical Follow-up Study
Post-Market Clinical Follow-up study in order to consolidate performance and safety data of the EPIONE® device when used for percutaneous procedures in the abdomen
- Trial name
- SaFE (NCT05529979)
- Testing
- EPIONE® CT-Guided Percutaneous procedures
- Where
- France
- Volunteers
- 55 people
- Sponsor
- Quantum Surgical
Liver Diseases
Benign Liver Optimal Core Study (Tissue Acquisition Comparison in Benign Liver Disease)
The primary purpose of this prospective, randomized, multicenter study is to evaluate and compare the amount and quality of tissue samples yielded in a liver biopsy comparing 2 different techniques of EUS guided CORE liver biopsy…
- Trial name
- BLOCS (NCT03245580)
- Testing
- Core Liver Biopsy
- Where
- 7 sites in United States
- Volunteers
- 153 people
- Sponsor
- Parkview Health
Non-alcoholic Fatty Liver Disease, Nonalcoholic Steatohepatitis
Endoscopic Ultrasound(EUS)-Guided TRUCUT Biopsy (EUS-TCB) of Suspected Nonalcoholic Fatty Liver Disease(NAFLD.)
Endoscopic Ultrasound involves the placement of a small flexible camera through the mouth and into the stomach to image various parts of the body.
- Trial name
- NAFLD (NCT00586313)
- Testing
- Tru-cut biopsy, Tru-cut
- Where
- United States
- Volunteers
- 21 people
- Sponsor
- Indiana University
Diagnoses Diseases, Ultrasound Therapy; Complications
19 Versus 22-Gauge Needle for EUS-LB
Chronic liver disorders (CLD) are a major cause of morbidity and mortality for individuals in the US. Though serologic analysis will often lead to a conclusive diagnosis, liver biopsy remains an important method for helping to…
- Conditions
- Diagnoses Diseases, Ultrasound Therapy; Complications, Liver Diseases
- Trial name
- EUSLB1922 (NCT02967991)
- Testing
- EUS-guided liver biopsy
- Where
- United States
- Volunteers
- 20 people, healthy volunteers welcome
- Sponsor
- Geisinger Clinic
Obesity, Non-Alcoholic Steatohepatitis
EUS Guided Core Liver Biopsy and IGB Placement for the Diagnosis and Management of NASH and Obesity
This study is designed to investigate the impact of weight loss achieved with the IGB on NASH with early fibrosis in a select cohort of patients with obesity preselected to have a high pre-test probability of having NASH with…
- Trial name
- NCT02880189
- Testing
- Orbera Intragastric Balloon, Endoscopic Ultrasound Guided Core Liver Biopsy
- Volunteers
- 21 people
- Sponsor
- Mayo Clinic
Wilson Disease
Copper Concentration & Histopathologic Changes in Liver Biopsy in Participants With Wilson Disease Treated With ALXN1840
The main objective of the study is to evaluate the change in liver copper (Cu) concentration following 48 weeks of treatment with ALXN1840 in adult participants with Wilson Disease (WD) who have been previously treated for at…
- Trial name
- NCT04422431
- Testing
- Bis-Choline Tetrathiomolybdate
- Where
- 12 sites in United States, Canada and 6 more
- Volunteers
- 31 people
- Sponsor
- Alexion Pharmaceuticals, Inc.
NASH
A Multiple Ascending Dose Study of Pegozafermin in Participants With Biopsy Confirmed Nonalcoholic Steatohepatitis (NASH) or Nonalcoholic Fatty Liver Disease (NAFLD) and at High Risk of NASH
Part 1: This is a multi-center evaluation of pegozafermin (administered weekly or every other week) in a randomized, double-blind, placebo-controlled study administered for 12 weeks in participants with NASH and NAFLD at high…
- Trial name
- NCT04048135
- Testing
- Pegozafermin
- Where
- 26 sites in United States, Puerto Rico
- Volunteers
- 101 people
- Sponsor
- 89bio, Inc.
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