Nonalcoholic Steatohepatitis Clinical Trial
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)
NCT number | NCT02815891 |
Other study ID # | TARGET-NASH |
Secondary ID | |
Status | Recruiting |
Phase | |
First received | |
Last updated | |
Start date | July 2016 |
Est. completion date | July 2036 |
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.
Status | Recruiting |
Enrollment | 15000 |
Est. completion date | July 2036 |
Est. primary completion date | July 2036 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 2 Years and older |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
Germany | Universitätsklinikum Aachen | Aachen | |
Germany | Charite Berlin | Berlin | |
Germany | Universitätsklinikum Frankfurt | Frankfurt | Hesse |
Spain | Hospital Clínic i Provincial de Barcelona | Barcelona | |
Spain | Hospital Marques de Valdecilla | Santander | Cantabria |
Spain | Hospital Virgen del Rocio | Sevilla | |
Spain | Hospital La Fe | Valencia | |
United States | University of Michigan | Ann Arbor | Michigan |
United States | Asheville Gastroenterology Associates, PA | Asheville | North Carolina |
United States | Atlanta Gastroenterology Associates, LLC | Atlanta | Georgia |
United States | Emory University - Children's Healthcare of Atlanta | Atlanta | Georgia |
United States | University of Colorado Anschutz Medical Campus | Aurora | Colorado |
United States | Mercy Medical Center | Baltimore | Maryland |
United States | The Children's Hospital at Montefiore, Division of Pediatric GI | Bronx | New York |
United States | University of Vermont Medical Center | Burlington | Vermont |
United States | University of North Carolina at Chapel Hill | Chapel Hill | North Carolina |
United States | Medical University of South Carolina | Charleston | South Carolina |
United States | Center for Liver Disease and Transplant at CMC | Charlotte | North Carolina |
United States | University of Virginia | Charlottesville | Virginia |
United States | Northwestern Medicine, Digestive Health Center | Chicago | Illinois |
United States | Rush University Medical Center | Chicago | Illinois |
United States | Cincinnati Children's Hospital Medical Center | Cincinnati | Ohio |
United States | University of Cincinnati | Cincinnati | Ohio |
United States | Gastro Florida | Clearwater | Florida |
United States | Cleveland Clinic Children's | Cleveland | Ohio |
United States | The Ohio State University Wexner Medical Center | Columbus | Ohio |
United States | Children's Health - Children's Medical Center Dallas | Dallas | Texas |
United States | Duke University Medical Center | Durham | North Carolina |
United States | University of Florida | Gainesville | Florida |
United States | University of Florida Hepatology Research at CTRB | Gainesville | Florida |
United States | Gastroenterology Associates | Greenville | South Carolina |
United States | Connecticut Children's Medical Center | Hartford | Connecticut |
United States | Connecticut Gastroenterology | Hartford | Connecticut |
United States | Houma Digestive Health Specialists | Houma | Louisiana |
United States | Baylor College of Medicine/Texas Children's Hospital | Houston | Texas |
United States | Research Specialists of Texas | Houston | Texas |
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 | UF Health Gastroenterology | Jacksonville | Florida |
United States | Pinnacle Clinical Research | Live Oak | Texas |
United States | University of Louisville | Louisville | Kentucky |
United States | University of Wisconsin Hospital & Clinics | Madison | Wisconsin |
United States | NorthWell Health - North Shore University Hospital | Manhasset | New York |
United States | Schiff Center for Liver Disease/University of Miami | Miami | Florida |
United States | University of Miami | Miami | Florida |
United States | Carteret Medical Group | Morehead City | North Carolina |
United States | West Virginia University | Morgantown | West Virginia |
United States | Rutgers - Robert Wood Johnson Medical School | New Brunswick | New Jersey |
United States | Tulane University School of Medicine | New Orleans | Louisiana |
United States | Columbia University Medical Center | New York | New York |
United States | Weill Cornell Medical College | New York | New York |
United States | The Children's Hospital at Oklahoma University Medical Center | Oklahoma City | Oklahoma |
United States | University of Nebraska Medical Center | Omaha | Nebraska |
United States | AdventHealth Diabetes Institute | Orlando | Florida |
United States | Advanced Gastroenterology Associates, LLC | Palm Harbor | Florida |
United States | Stanford University | Palo Alto | California |
United States | California Liver Research Institute | Pasadena | California |
United States | St. Christopher's Hospital for Children | Philadelphia | Pennsylvania |
United States | University of Pennsylvania | Philadelphia | Pennsylvania |
United States | Banner University Medical Center - Phoenix Transplant Center and Advanced Liver Clinic | Phoenix | Arizona |
United States | Children's Hospital of Pittsburgh of UPMC | Pittsburgh | Pennsylvania |
United States | Bon Secours Liver Institute of Virginia | Richmond | Virginia |
United States | Virginia Commonwealth University | Richmond | Virginia |
United States | Mayo Clinic | Rochester | Minnesota |
United States | University of California, Davis | Sacramento | California |
United States | Saint Louis University - Gastroenterology and Hepatology, Clinical Research Unit | Saint Louis | Missouri |
United States | Silicon Valley Research Institute | San Jose | California |
United States | University of Washington | Seattle | Washington |
United States | Louisiana Research Center, LLC | Shreveport | Louisiana |
United States | NorthShore University HealthSystem | Skokie | Illinois |
United States | Tampa General Medical Group | Tampa | Florida |
United States | Medstar Georgetown Transplant Institute | Washington | District of Columbia |
United States | Digestive Health Specialists, PA | Winston-Salem | North Carolina |
Lead Sponsor | Collaborator |
---|---|
Target PharmaSolutions, Inc. |
United States, Germany, Spain,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Establish an understanding of the current natural history of NASH at academic and community medical centers | 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. | 10 years | |
Primary | Evaluate NASH treatment regimens being used in clinical practice | 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. | 10 years | |
Primary | Examine populations underrepresented in phase II-III clinical trials | 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. | 10 years | |
Primary | Evaluate optimal duration and combination of NASH therapies to achieve clinical response and clinical remission | 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. | 10 years | |
Primary | Examine liver histology | 10 years | ||
Primary | Estimate adverse event frequency and severity and describe management practices | 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). | 10 years | |
Primary | Evaluate the impact of NASH therapies on medical co-morbidities | 10 years |
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