Noninvasive Biomarkers of Metabolic Liver Disease 1.1

Status Completed

Clinical Trial Summary

NIMBLE is a comprehensive collaborative effort to standardize, compare, validate, and advance the regulatory qualification of imaging and circulating biomarkers to diagnose and stage nonalcoholic steatohepatitis (NASH), and to predict and assess response to therapeutic intervention (https://fnih.org/what-we-do/biomarkers-consortium/programs/nimble). This study focuses on estimating the repeatability and reproducibility of ultrasound elastography-based biomarkers across a range of fibrosis stages.

Clinical Trial Description

Study 1.1, is a prospective, two-center, short-term cross-sectional study to assess the reproducibility and repeatability of a set of specified ultrasound-based quantitative imaging biomarkers. The primary focus will be on imaging biomarkers of the liver fibrosis component of nonalcoholic fatty liver disease (NAFLD), rather than the steatosis or inflammation component. The rationale is that the fibrosis component is linked most closely to survival and other clinical outcomes. Study 1.1 will also collect data to explore vendor- or device-specific investigational biomarkers on other components of NAFLD such as steatosis and possibly inflammation. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT04828551
Study type	Interventional
Source	Massachusetts General Hospital
Contact
Status	Completed
Phase	N/A
Start date	March 18, 2021
Completion date	November 20, 2021

View Details

See also
Status	Clinical Trial	Phase
Completed	`NCT03375008` - Predictable MR Index for Nonalcoholic Steatohepatitis (NASH)	N/A
Recruiting	`NCT05979779` - Ph 2 Study of the Safety and Efficacy of Three HU6 Dose Levels and Placebo in Nonalcoholic Steatohepatitis	Phase 2
Withdrawn	`NCT02769091` - A Study in Adult Patients With Nonalcoholic Steatohepatitis Who Also Have Type 2 Diabetes	Phase 2
Completed	`NCT02654977` - CLINICAL PROTOCOL to Investigate the Long-term Safety and Efficacy of Metreleptin in Various Forms of Partial Lipodystrophy	Phase 2
Recruiting	`NCT05211284` - Saroglitazar Magnesium 4 mg for NASH in People Living With HIV in the US	Phase 2
Completed	`NCT02421094` - Clinical Trial to Evaluate Efficacy of GR-MD-02 for Treatment of Liver Fibrosis in Patients With NASH With Advanced Fibrosis	Phase 2
Completed	`NCT01205087` - Safety and Efficacy of Oral Administration of Anti-CD3 Monoclonal Antibody (mAb)in Patients With the Metabolic Syndrome	Phase 2
Recruiting	`NCT00152711` - Impact of nCPAP Treatment on Liver Function in Patients With Sleep Apnea Syndrome and Nonalcoholic Steatohepatitis	N/A
Completed	`NCT02217475` - Efficacy and Safety Study of Cenicriviroc for the Treatment of Nonalcoholic Steatohepatitis (NASH) in Adult Participants With Liver Fibrosis	Phase 2
Completed	`NCT04031729` - Aspirin for the Treatment of Nonalcoholic Fatty Liver Disease	Phase 1/Phase 2
Completed	`NCT03674476` - An Investigational Study to Evaluate Experimental Medication BMS-986036 in Participants With Different Levels of Kidney Function	Phase 1
Recruiting	`NCT03725631` - Non-invasive Evaluation of Liver Fibrosis, Steatosis, and NASH in NAFLD	N/A
Terminated	`NCT04565717` - A Study of ALN-HSD in Healthy Adult Subjects and Adult Patients With Nonalcoholic Steatohepatitis (NASH)	Phase 1
Completed	`NCT01679197` - Clinical Protocol to Investigate the Efficacy of Recombinant Human Leptin (Metreleptin) in Nonalcoholic Steatohepatitis (NASH) or Nonalcoholic Fatty Liver Disease (NAFLD) Associated With Lipodystrophy	Phase 2
Active, not recruiting	`NCT05084404` - Efficacy and Safety of Guanabenz for Nonalcoholic Fatty Liver Disease	Phase 2
Active, not recruiting	`NCT02574325` - A Study to Assess ARI-3037MO on Hepatic Fat Metabolism in Patients With Dysglycemia and Evidence of Hepatic Steatosis	Phase 2
Terminated	`NCT00878592` - Effect of Dietary and Life Style Modification on Post Liver Transplant Obesity	N/A
Recruiting	`NCT02148471` - Fatty Acids, Genes and Microbiota in Fatty Liver	N/A
Completed	`NCT00227110` - Role of Pioglitazone in the Treatment of Non-alcoholic Steatohepatitis (NASH)	Phase 4
Completed	`NCT03656744` - A Study of HTD1801 in Adults With Nonalcoholic Steatohepatitis (NASH) and Type 2 Diabetes Mellitus (T2DM)	Phase 2