Clinical trial NCT02815891: A Longitudinal Observational Study of Patients With Nonalcoholic Steatohepatitis (NASH) and Related Conditions Across the Entire Spectrum of Nonalcoholic Fatty Liver Disease (NAFLD)
Official title: A Longitudinal Observational Study of Patients With Nonalcoholic Steatohepatitis (NASH) and Related Conditions Across the Entire Spectrum of Nonalcoholic Fatty Liver Disease (NAFLD)
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Nonalcoholic Fatty Liver
Nonalcoholic Steatohepatitis
Lead sponsor: Target PharmaSolutions, Inc.
Sponsor class: INDUSTRY
First posted: 2016-06-28
Enrollment: 15000
Sex: ALL
Minimum age (years): 2
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adults and children with NAFL or NASH who are being seen specifically to address this disease process

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.


Eligibility 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.

Primary outcomes:
measure: Establish an understanding of the current natural history of NASH at academic and community medical centers
timeFrame: 10 years
measure: Evaluate NASH treatment regimens being used in clinical practice
timeFrame: 10 years
measure: Examine populations underrepresented in phase II-III clinical trials
timeFrame: 10 years
measure: Evaluate optimal duration and combination of NASH therapies to achieve clinical response and clinical remission
timeFrame: 10 years
measure: Examine liver histology
timeFrame: 10 years
measure: Estimate adverse event frequency and severity and describe management practices
timeFrame: 10 years
measure: Evaluate the impact of NASH therapies on medical co-morbidities
timeFrame: 10 years
Secondary outcomes:
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Banner University Medical Center - Phoenix Transplant Center and Advanced Liver Clinic
state: Arizona
city: Palo Alto
country: United States
facility: Stanford University
state: California
city: Pasadena
country: United States
facility: California Liver Research Institute
state: California
city: Sacramento
country: United States
facility: University of California, Davis
state: California
city: San Jose
country: United States
facility: Silicon Valley Research Institute
state: California
city: Aurora
country: United States
facility: University of Colorado Anschutz Medical Campus
state: Colorado
city: Hartford
country: United States
facility: Connecticut Gastroenterology
state: Connecticut
city: Hartford
country: United States
facility: Connecticut Children's Medical Center
state: Connecticut
city: Washington
country: United States
facility: Medstar Georgetown Transplant Institute
state: District of Columbia
city: Clearwater
country: United States
facility: Gastro Florida
state: Florida
city: Gainesville
country: United States
facility: University of Florida Hepatology Research at CTRB
state: Florida
city: Gainesville
country: United States
facility: University of Florida
state: Florida
city: Jacksonville
country: United States
facility: UF Health Gastroenterology
state: Florida
city: Miami
country: United States
facility: University of Miami
state: Florida
city: Miami
country: United States
facility: Schiff Center for Liver Disease/University of Miami
state: Florida
city: Orlando
country: United States
facility: AdventHealth Diabetes Institute
state: Florida
city: Palm Harbor
country: United States
facility: Advanced Gastroenterology Associates, LLC
state: Florida
city: Tampa
country: United States
facility: Tampa General Medical Group
state: Florida
city: Atlanta
country: United States
facility: Atlanta Gastroenterology Associates, LLC
state: Georgia
city: Atlanta
country: United States
facility: Emory University - Children's Healthcare of Atlanta
state: Georgia
city: Chicago
country: United States
facility: Northwestern Medicine, Digestive Health Center
state: Illinois
city: Chicago
country: United States
facility: Rush University Medical Center
state: Illinois
city: Skokie
country: United States
facility: NorthShore University HealthSystem
state: Illinois
city: Indianapolis
country: United States
facility: Indiana University - Division of Gastroenterology and Hepatology
state: Indiana
city: Indianapolis
country: United States
facility: Indianapolis Gastroenterology Research Foundation
state: Indiana
city: Iowa City
country: United States
facility: University of Iowa Hospitals and Clinics
state: Iowa
city: Louisville
country: United States
facility: University of Louisville
state: Kentucky
city: Houma
country: United States
facility: Houma Digestive Health Specialists
state: Louisiana
city: New Orleans
country: United States
facility: Tulane University School of Medicine
state: Louisiana
city: Shreveport
country: United States
facility: Louisiana Research Center, LLC
state: Louisiana
city: Baltimore
country: United States
facility: Mercy Medical Center
state: Maryland
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
city: Saint Louis
country: United States
facility: Saint Louis University - Gastroenterology and Hepatology, Clinical Research Unit
state: Missouri
city: Omaha
country: United States
facility: University of Nebraska Medical Center
state: Nebraska
city: New Brunswick
country: United States
facility: Rutgers - Robert Wood Johnson Medical School
state: New Jersey
city: Bronx
country: United States
facility: The Children's Hospital at Montefiore, Division of Pediatric GI
state: New York
city: Manhasset
country: United States
facility: NorthWell Health - North Shore University Hospital
state: New York
city: New York
country: United States
facility: Weill Cornell Medical College
state: New York
city: New York
country: United States
facility: Columbia University Medical Center
state: New York
city: Asheville
country: United States
facility: Asheville Gastroenterology Associates, PA
state: North Carolina
city: Chapel Hill
country: United States
facility: University of North Carolina at Chapel Hill
state: North Carolina
city: Charlotte
country: United States
facility: Center for Liver Disease and Transplant at CMC
state: North Carolina
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
city: Morehead City
country: United States
facility: Carteret Medical Group
state: North Carolina
city: Winston-Salem
country: United States
facility: Digestive Health Specialists, PA
state: North Carolina
city: Cincinnati
country: United States
facility: Cincinnati Children's Hospital Medical Center
state: Ohio
city: Cincinnati
country: United States
facility: University of Cincinnati
state: Ohio
city: Cleveland
country: United States
facility: Cleveland Clinic Children's
state: Ohio
city: Columbus
country: United States
facility: The Ohio State University Wexner Medical Center
state: Ohio
city: Oklahoma City
country: United States
facility: The Children's Hospital at Oklahoma University Medical Center
state: Oklahoma
city: Philadelphia
country: United States
facility: University of Pennsylvania
state: Pennsylvania
city: Philadelphia
country: United States
facility: St. Christopher's Hospital for Children
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Children's Hospital of Pittsburgh of UPMC
state: Pennsylvania
city: Charleston
country: United States
facility: Medical University of South Carolina
state: South Carolina
city: Greenville
country: United States
facility: Gastroenterology Associates
state: South Carolina
city: Dallas
country: United States
facility: Children's Health - Children's Medical Center Dallas
state: Texas
city: Houston
country: United States
facility: Baylor College of Medicine/Texas Children's Hospital
state: Texas
city: Houston
country: United States
facility: Research Specialists of Texas
state: Texas
city: Live Oak
country: United States
facility: Pinnacle Clinical Research
state: Texas
city: Burlington
country: United States
facility: University of Vermont Medical Center
state: Vermont
city: Charlottesville
country: United States
facility: University of Virginia
state: Virginia
city: Richmond
country: United States
facility: Bon Secours Liver Institute of Virginia
state: Virginia
city: Richmond
country: United States
facility: Virginia Commonwealth University
state: Virginia
city: Seattle
country: United States
facility: University of Washington
state: Washington
city: Morgantown
country: United States
facility: West Virginia University
state: West Virginia
city: Madison
country: United States
facility: University of Wisconsin Hospital & Clinics
state: Wisconsin
city: Frankfurt
country: Germany
facility: Universitätsklinikum Frankfurt
state: Hesse
city: Aachen
country: Germany
facility: Universitätsklinikum Aachen
city: Berlin
country: Germany
facility: Charite Berlin
city: Santander
country: Spain
facility: Hospital Marques de Valdecilla
state: Cantabria
city: Barcelona
country: Spain
facility: Hospital Clínic i Provincial de Barcelona
city: Sevilla
country: Spain
facility: Hospital Virgen del Rocio
city: Valencia
country: Spain
facility: Hospital La Fe
Study officials:
References:
citation: Malespin MH, Barritt AS 4th, Watkins SE, Schoen C, Tincopa MA, Corbin KD, Mospan AR, Munoz B, Trinh HN, Weiss LM, Reddy KR, Loomba R, Kemmer N, Lok AS. Weight Loss and Weight Regain in Usual Clinical Practice: Results From the TARGET-NASH Observational Cohort. Clin Gastroenterol Hepatol. 2022 Oct;20(10):2393-2395.e4. doi: 10.1016/j.cgh.2021.01.023. Epub 2021 Jan 21.
citation: Weinberg EM, Trinh HN, Firpi RJ, Bhamidimarri KR, Klein S, Durlam J, Watkins S, Reddy KR, Weiss M, Zink RC, Lok AS. Lean Americans With Nonalcoholic Fatty Liver Disease Have Lower Rates of Cirrhosis and Comorbid Diseases. Clin Gastroenterol Hepatol. 2021 May;19(5):996-1008.e6. doi: 10.1016/j.cgh.2020.06.066. Epub 2020 Jul 3.