Observational study of patients with nonalcoholic fatty liver disease
A Longitudinal Observational Study of Patients With Nonalcoholic Steatohepatitis (NASH) and Related Conditions Across the Entire Spectrum of Nonalcoholic Fatty Liver Disease (NAFLD)
This study is trying to learn more about nonalcoholic fatty liver disease by tracking patients to see how well current and future treatments work in real life.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 15000 (estimated) |
| Ages | 2 Years and up |
| Sex | All |
| Sponsor | Target PharmaSolutions, Inc. Industry-sponsored |
| Locations | 74 sites (Phoenix, Arizona and 73 other locations) |
| Trial ID | NCT02815891 on ClinicalTrials.gov |
What this trial studies
TARGET-NASH is a longitudinal observational cohort study that focuses on patients being managed for nonalcoholic steatohepatitis (NASH) and related conditions across the spectrum of nonalcoholic fatty liver disease (NAFLD). This study aims to create a research registry of patients with NAFL or NASH in both academic and community settings to evaluate the safety and effectiveness of current and future therapies. By collecting real-world data, the study seeks to enhance understanding of the disease and improve patient management.
Who should consider this trial
Good fit: Ideal candidates include adults and children aged 2 or older who are being managed or treated for nonalcoholic fatty liver disease.
Not a fit: Patients who are unable to provide informed assent or consent will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved treatment strategies and better management of nonalcoholic fatty liver disease for patients.
How similar studies have performed: Other observational studies in similar contexts have shown promise in understanding and managing liver diseases, indicating that this approach is supported by prior research.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Adults and children (age 2 or older) being managed or treated for nonalcoholic fatty liver disease. Diagnosis is based on the clinical judgement of the care provider. Exclusion Criteria: 1. Inability to provide informed assent/consent.
Where this trial is running
Phoenix, Arizona and 73 other locations
- Banner University Medical Center - Phoenix Transplant Center and Advanced Liver Clinic — Phoenix, Arizona, United States (Terminated)
- Stanford University — Palo Alto, California, United States (Terminated)
- California Liver Research Institute — Pasadena, California, United States (Active_not_recruiting)
- University of California, Davis — Sacramento, California, United States (Terminated)
- Silicon Valley Research Institute — San Jose, California, United States (Terminated)
- University of Colorado Anschutz Medical Campus — Aurora, Colorado, United States (Active_not_recruiting)
- Connecticut Gastroenterology — Hartford, Connecticut, United States (Terminated)
- Connecticut Children's Medical Center — Hartford, Connecticut, United States (Active_not_recruiting)
- Medstar Georgetown Transplant Institute — Washington, District of Columbia, United States (Terminated)
- Gastro Florida — Clearwater, Florida, United States (Active_not_recruiting)
- University of Florida Hepatology Research at CTRB — Gainesville, Florida, United States (Active_not_recruiting)
- University of Florida — Gainesville, Florida, United States (Active_not_recruiting)
- UF Health Gastroenterology — Jacksonville, Florida, United States (Terminated)
- University of Miami — Miami, Florida, United States (Terminated)
- Schiff Center for Liver Disease/University of Miami — Miami, Florida, United States (Active_not_recruiting)
- AdventHealth Diabetes Institute — Orlando, Florida, United States (Terminated)
- Advanced Gastroenterology Associates, LLC — Palm Harbor, Florida, United States (Active_not_recruiting)
- Tampa General Medical Group — Tampa, Florida, United States (Terminated)
- Atlanta Gastroenterology Associates, LLC — Atlanta, Georgia, United States (Active_not_recruiting)
- Emory University - Children's Healthcare of Atlanta — Atlanta, Georgia, United States (Active_not_recruiting)
- Northwestern Medicine, Digestive Health Center — Chicago, Illinois, United States (Active_not_recruiting)
- Rush University Medical Center — Chicago, Illinois, United States (Recruiting)
- NorthShore University HealthSystem — Skokie, Illinois, United States (Terminated)
- Indiana University - Division of Gastroenterology and Hepatology — Indianapolis, Indiana, United States (Active_not_recruiting)
- Indianapolis Gastroenterology Research Foundation — Indianapolis, Indiana, United States (Terminated)
- University of Iowa Hospitals and Clinics — Iowa City, Iowa, United States (Active_not_recruiting)
- University of Louisville — Louisville, Kentucky, United States (Active_not_recruiting)
- Houma Digestive Health Specialists — Houma, Louisiana, United States (Withdrawn)
- Tulane University School of Medicine — New Orleans, Louisiana, United States (Terminated)
- Louisiana Research Center, LLC — Shreveport, Louisiana, United States (Terminated)
- Mercy Medical Center — Baltimore, Maryland, United States (Terminated)
- University of Michigan — Ann Arbor, Michigan, United States (Active_not_recruiting)
- Mayo Clinic — Rochester, Minnesota, United States (Terminated)
- Saint Louis University - Gastroenterology and Hepatology, Clinical Research Unit — Saint Louis, Missouri, United States (Active_not_recruiting)
- University of Nebraska Medical Center — Omaha, Nebraska, United States (Active_not_recruiting)
- Rutgers - Robert Wood Johnson Medical School — New Brunswick, New Jersey, United States (Terminated)
- The Children's Hospital at Montefiore, Division of Pediatric GI — Bronx, New York, United States (Active_not_recruiting)
- NorthWell Health - North Shore University Hospital — Manhasset, New York, United States (Terminated)
- Weill Cornell Medical College — New York, New York, United States (Active_not_recruiting)
- Columbia University Medical Center — New York, New York, United States (Terminated)
- Asheville Gastroenterology Associates, PA — Asheville, North Carolina, United States (Terminated)
- University of North Carolina at Chapel Hill — Chapel Hill, North Carolina, United States (Active_not_recruiting)
- Center for Liver Disease and Transplant at CMC — Charlotte, North Carolina, United States (Terminated)
- Duke University Medical Center — Durham, North Carolina, United States (Terminated)
- Carteret Medical Group — Morehead City, North Carolina, United States (Terminated)
- Digestive Health Specialists, PA — Winston-Salem, North Carolina, United States (Terminated)
- Cincinnati Children's Hospital Medical Center — Cincinnati, Ohio, United States (Terminated)
- University of Cincinnati — Cincinnati, Ohio, United States (Active_not_recruiting)
- Cleveland Clinic Children's — Cleveland, Ohio, United States (Active_not_recruiting)
- The Ohio State University Wexner Medical Center — Columbus, Ohio, United States (Active_not_recruiting)
+24 more sites — see ClinicalTrials.gov for the full list.
Study contacts
- Study coordinator: Ellie Michalski
- Email: emichalski@targetrwe.com
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.