A Longitudinal Observational Study of Patients With Nonalcoholic Steatohepatitis (NASH) and Related Conditions Across the Entire Spectrum of Nonalcoholic Fatty Liver Disease (NAFLD)
- Conditions
- Nonalcoholic Fatty LiverNonalcoholic Steatohepatitis
- Registration Number
- NCT02815891
- Lead Sponsor
- Target PharmaSolutions, Inc.
- Brief Summary
TARGET-NASH is a longitudinal observational cohort study of patients being managed for NASH and related conditions across the entire spectrum NAFLD in usual clinical practice. TARGET-NASH is a research registry of patients with NAFL or NASH within academic and community real-world practices maintained in order to assess the safety and effectiveness of current and future therapies.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 15000
- 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.
- Inability to provide informed assent/consent.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Examine liver histology 10 years Estimate adverse event frequency and severity and describe management practices 10 years NASH can often be an asymptomatic disease in the setting of other disease-related comorbidities such as diabetes and cardiovascular disease. Once NASH progresses to cirrhosis, these patients can suffer the attendant complications of decompensated liver disease including debilitating fatigue, muscle wasting, ascites, bleeding, encephalopathy, hepatocellular carcinoma, and death. NASH therapies may increase the frequency and severity of certain adverse events, such as edema (pioglitazone), some cancers (vitamin E), and new agents or combinations of agents may have their own unique adverse event profiles and varying needs for management plans (e.g., pruritus and dyslipidemia).
Evaluate the impact of NASH therapies on medical co-morbidities 10 years Establish an understanding of the current natural history of NASH at academic and community medical centers 10 years A detailed analysis of demographics, concurrent medications, metabolic and cardiovascular co-morbidities, staging of liver disease, and outcomes for patients with NASH managed in diverse clinical settings will serve as an important comparator for subsequent interventions that alter the treatment paradigm for this disease.
Evaluate NASH treatment regimens being used in clinical practice 10 years Currently, there are no FDA approved therapies for NASH, however clinicians may use a variety of interventions including diet and exercise programs, vitamin E, bariatric surgery or other unapproved uses of some cholesterol, lipid lowering, anti-diabetic and anti-inflammatory medications as well as alternative medications. TARGET-NASH will monitor the safety and effectiveness of the various treatment choices in enrolled patients.
Examine populations underrepresented in phase II-III clinical trials 10 years Patients with cirrhosis, age \> 70, patients who consume moderate amounts of alcohol and patients with multiple comorbidities such as severe depression, chronic fatigue, fibromyalgia, type 2 diabetes, inflammatory bowel disease, or cardiovascular disease.
Evaluate optimal duration and combination of NASH therapies to achieve clinical response and clinical remission 10 years In addition to diet and exercise, type, dose and duration of therapy of each NASH treatment (both current unapproved therapies and future FDA approved drugs) will be closely followed, with a goal to monitor treatment paradigms and various combination regimens for clinical response and clinical remission.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (74)
Banner University Medical Center - Phoenix Transplant Center and Advanced Liver Clinic
🇺🇸Phoenix, Arizona, United States
Stanford University
🇺🇸Palo Alto, California, United States
California Liver Research Institute
🇺🇸Pasadena, California, United States
University of California, Davis
🇺🇸Sacramento, California, United States
Silicon Valley Research Institute
🇺🇸San Jose, California, United States
University of Colorado Anschutz Medical Campus
🇺🇸Aurora, Colorado, United States
Connecticut Gastroenterology
🇺🇸Hartford, Connecticut, United States
Connecticut Children's Medical Center
🇺🇸Hartford, Connecticut, United States
Medstar Georgetown Transplant Institute
🇺🇸Washington, District of Columbia, United States
Gastro Florida
🇺🇸Clearwater, Florida, United States
University of Florida Hepatology Research at CTRB
🇺🇸Gainesville, Florida, United States
University of Florida
🇺🇸Gainesville, Florida, United States
UF Health Gastroenterology
🇺🇸Jacksonville, Florida, United States
University of Miami
🇺🇸Miami, Florida, United States
Schiff Center for Liver Disease/University of Miami
🇺🇸Miami, Florida, United States
AdventHealth Diabetes Institute
🇺🇸Orlando, Florida, United States
Advanced Gastroenterology Associates, LLC
🇺🇸Palm Harbor, Florida, United States
Tampa General Medical Group
🇺🇸Tampa, Florida, United States
Atlanta Gastroenterology Associates, LLC
🇺🇸Atlanta, Georgia, United States
Emory University - Children's Healthcare of Atlanta
🇺🇸Atlanta, Georgia, United States
Northwestern Medicine, Digestive Health Center
🇺🇸Chicago, Illinois, United States
Rush University Medical Center
🇺🇸Chicago, Illinois, United States
NorthShore University HealthSystem
🇺🇸Skokie, Illinois, United States
Indiana University - Division of Gastroenterology and Hepatology
🇺🇸Indianapolis, Indiana, United States
Indianapolis Gastroenterology Research Foundation
🇺🇸Indianapolis, Indiana, United States
University of Iowa Hospitals and Clinics
🇺🇸Iowa City, Iowa, United States
University of Louisville
🇺🇸Louisville, Kentucky, United States
Houma Digestive Health Specialists
🇺🇸Houma, Louisiana, United States
Tulane University School of Medicine
🇺🇸New Orleans, Louisiana, United States
Louisiana Research Center, LLC
🇺🇸Shreveport, Louisiana, United States
Mercy Medical Center
🇺🇸Baltimore, Maryland, United States
University of Michigan
🇺🇸Ann Arbor, Michigan, United States
Mayo Clinic
🇺🇸Rochester, Minnesota, United States
Saint Louis University - Gastroenterology and Hepatology, Clinical Research Unit
🇺🇸Saint Louis, Missouri, United States
University of Nebraska Medical Center
🇺🇸Omaha, Nebraska, United States
Rutgers - Robert Wood Johnson Medical School
🇺🇸New Brunswick, New Jersey, United States
The Children's Hospital at Montefiore, Division of Pediatric GI
🇺🇸Bronx, New York, United States
NorthWell Health - North Shore University Hospital
🇺🇸Manhasset, New York, United States
Weill Cornell Medical College
🇺🇸New York, New York, United States
Columbia University Medical Center
🇺🇸New York, New York, United States
Asheville Gastroenterology Associates, PA
🇺🇸Asheville, North Carolina, United States
University of North Carolina at Chapel Hill
🇺🇸Chapel Hill, North Carolina, United States
Center for Liver Disease and Transplant at CMC
🇺🇸Charlotte, North Carolina, United States
Duke University Medical Center
🇺🇸Durham, North Carolina, United States
Carteret Medical Group
🇺🇸Morehead City, North Carolina, United States
Digestive Health Specialists, PA
🇺🇸Winston-Salem, North Carolina, United States
Cincinnati Children's Hospital Medical Center
🇺🇸Cincinnati, Ohio, United States
University of Cincinnati
🇺🇸Cincinnati, Ohio, United States
Cleveland Clinic Children's
🇺🇸Cleveland, Ohio, United States
The Ohio State University Wexner Medical Center
🇺🇸Columbus, Ohio, United States
The Children's Hospital at Oklahoma University Medical Center
🇺🇸Oklahoma City, Oklahoma, United States
University of Pennsylvania
🇺🇸Philadelphia, Pennsylvania, United States
St. Christopher's Hospital for Children
🇺🇸Philadelphia, Pennsylvania, United States
Children's Hospital of Pittsburgh of UPMC
🇺🇸Pittsburgh, Pennsylvania, United States
Medical University of South Carolina
🇺🇸Charleston, South Carolina, United States
Gastroenterology Associates
🇺🇸Greenville, South Carolina, United States
Children's Health - Children's Medical Center Dallas
🇺🇸Dallas, Texas, United States
Baylor College of Medicine/Texas Children's Hospital
🇺🇸Houston, Texas, United States
Research Specialists of Texas
🇺🇸Houston, Texas, United States
Pinnacle Clinical Research
🇺🇸Live Oak, Texas, United States
University of Vermont Medical Center
🇺🇸Burlington, Vermont, United States
University of Virginia
🇺🇸Charlottesville, Virginia, United States
Bon Secours Liver Institute of Virginia
🇺🇸Richmond, Virginia, United States
Virginia Commonwealth University
🇺🇸Richmond, Virginia, United States
University of Washington
🇺🇸Seattle, Washington, United States
West Virginia University
🇺🇸Morgantown, West Virginia, United States
University of Wisconsin Hospital & Clinics
🇺🇸Madison, Wisconsin, United States
Universitätsklinikum Frankfurt
🇩🇪Frankfurt, Hesse, Germany
Universitätsklinikum Aachen
🇩🇪Aachen, Germany
Charite Berlin
🇩🇪Berlin, Germany
Hospital Marques de Valdecilla
🇪🇸Santander, Cantabria, Spain
Hospital Clínic i Provincial de Barcelona
🇪🇸Barcelona, Spain
Hospital Virgen del Rocio
🇪🇸Sevilla, Spain
Hospital La Fe
🇪🇸Valencia, Spain