Clincosm LogoSign in Get a demo

A Longitudinal Observational Study of Patients With Nonalcoholic Steatohepatitis (NASH) and Related Conditions Across the Entire Spectrum of Nonalcoholic Fatty Liver Disease (NAFLD)

Sponsor
Target PharmaSolutions, Inc. (Industry)
Overall Status
Recruiting
CT.gov ID
NCT02815891
Collaborator
(none)
15,000
Enrollment
74
Locations
240
Duration (Months)
202.7
Patients Per Site
0.8
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational [Patient Registry]
    Anticipated Enrollment :
    15000 participants
    Observational Model:
    Cohort
    Time Perspective:
    Other
    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 Start Date :
    Jul 1, 2016
    Anticipated Primary Completion Date :
    Jul 1, 2036
    Anticipated Study Completion Date :
    Jul 1, 2036

    Outcome Measures

    Primary Outcome Measures

    1. 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.

    2. 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.

    3. 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.

    4. 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.

    5. Examine liver histology [10 years]

    6. 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).

    7. Evaluate the impact of NASH therapies on medical co-morbidities [10 years]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    2 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Banner University Medical Center - Phoenix Transplant Center and Advanced Liver Clinic Phoenix Arizona United States 85006
    2 Stanford University Palo Alto California United States 94304
    3 California Liver Research Institute Pasadena California United States 91105
    4 University of California, Davis Sacramento California United States 95817
    5 Silicon Valley Research Institute San Jose California United States 95128
    6 University of Colorado Anschutz Medical Campus Aurora Colorado United States 80045
    7 Connecticut Gastroenterology Hartford Connecticut United States 06105
    8 Connecticut Children's Medical Center Hartford Connecticut United States 06106
    9 Medstar Georgetown Transplant Institute Washington District of Columbia United States 20007
    10 Gastro Florida Clearwater Florida United States 33762
    11 University of Florida Hepatology Research at CTRB Gainesville Florida United States 32610-0272
    12 University of Florida Gainesville Florida United States 32610
    13 UF Health Gastroenterology Jacksonville Florida United States 32207
    14 University of Miami Miami Florida United States 33009
    15 Schiff Center for Liver Disease/University of Miami Miami Florida United States 33136
    16 AdventHealth Diabetes Institute Orlando Florida United States 32804
    17 Advanced Gastroenterology Associates, LLC Palm Harbor Florida United States 34041
    18 Tampa General Medical Group Tampa Florida United States 33606
    19 Atlanta Gastroenterology Associates, LLC Atlanta Georgia United States 30308
    20 Emory University - Children's Healthcare of Atlanta Atlanta Georgia United States 30322
    21 Northwestern Medicine, Digestive Health Center Chicago Illinois United States 60611
    22 Rush University Medical Center Chicago Illinois United States 60612
    23 NorthShore University HealthSystem Skokie Illinois United States 60077
    24 Indiana University - Division of Gastroenterology and Hepatology Indianapolis Indiana United States 46202
    25 Indianapolis Gastroenterology Research Foundation Indianapolis Indiana United States 46237
    26 University of Iowa Hospitals and Clinics Iowa City Iowa United States 52242
    27 University of Louisville Louisville Kentucky United States 40202
    28 Houma Digestive Health Specialists Houma Louisiana United States 70360
    29 Tulane University School of Medicine New Orleans Louisiana United States 70112
    30 Louisiana Research Center, LLC Shreveport Louisiana United States 71105
    31 Mercy Medical Center Baltimore Maryland United States 21202
    32 University of Michigan Ann Arbor Michigan United States 48109
    33 Mayo Clinic Rochester Minnesota United States 55905
    34 Saint Louis University - Gastroenterology and Hepatology, Clinical Research Unit Saint Louis Missouri United States 63104
    35 University of Nebraska Medical Center Omaha Nebraska United States 68106
    36 Rutgers - Robert Wood Johnson Medical School New Brunswick New Jersey United States 08901
    37 The Children's Hospital at Montefiore, Division of Pediatric GI Bronx New York United States 10467
    38 NorthWell Health - North Shore University Hospital Manhasset New York United States 11030
    39 Weill Cornell Medical College New York New York United States 10021
    40 Columbia University Medical Center New York New York United States 10032
    41 Asheville Gastroenterology Associates, PA Asheville North Carolina United States 28801
    42 University of North Carolina at Chapel Hill Chapel Hill North Carolina United States 27599
    43 Center for Liver Disease and Transplant at CMC Charlotte North Carolina United States 28204
    44 Duke University Medical Center Durham North Carolina United States 27710
    45 Carteret Medical Group Morehead City North Carolina United States 28557
    46 Digestive Health Specialists, PA Winston-Salem North Carolina United States 27103
    47 Cincinnati Children's Hospital Medical Center Cincinnati Ohio United States 45229-3039
    48 University of Cincinnati Cincinnati Ohio United States 45267
    49 Cleveland Clinic Children's Cleveland Ohio United States 44195
    50 The Ohio State University Wexner Medical Center Columbus Ohio United States 43203
    51 The Children's Hospital at Oklahoma University Medical Center Oklahoma City Oklahoma United States 73104
    52 University of Pennsylvania Philadelphia Pennsylvania United States 19104
    53 St. Christopher's Hospital for Children Philadelphia Pennsylvania United States 19134
    54 Children's Hospital of Pittsburgh of UPMC Pittsburgh Pennsylvania United States 15224
    55 Medical University of South Carolina Charleston South Carolina United States 29425
    56 Gastroenterology Associates Greenville South Carolina United States 29615
    57 Children's Health - Children's Medical Center Dallas Dallas Texas United States 75235
    58 Baylor College of Medicine/Texas Children's Hospital Houston Texas United States 77030
    59 Research Specialists of Texas Houston Texas United States 77030
    60 Pinnacle Clinical Research Live Oak Texas United States 78233
    61 University of Vermont Medical Center Burlington Vermont United States 05401
    62 University of Virginia Charlottesville Virginia United States 22908
    63 Bon Secours Liver Institute of Virginia Richmond Virginia United States 23226
    64 Virginia Commonwealth University Richmond Virginia United States 23298
    65 University of Washington Seattle Washington United States 98104
    66 West Virginia University Morgantown West Virginia United States 26506
    67 University of Wisconsin Hospital & Clinics Madison Wisconsin United States 53705
    68 Universitätsklinikum Frankfurt Frankfurt Hesse Germany 60590
    69 Universitätsklinikum Aachen Aachen Germany
    70 Charite Berlin Berlin Germany
    71 Hospital Marques de Valdecilla Santander Cantabria Spain
    72 Hospital Clínic i Provincial de Barcelona Barcelona Spain
    73 Hospital Virgen del Rocio Sevilla Spain
    74 Hospital La Fe Valencia Spain

    Sponsors and Collaborators

    • Target PharmaSolutions, Inc.

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Target PharmaSolutions, Inc.
    ClinicalTrials.gov Identifier:
    NCT02815891
    Other Study ID Numbers:
    • TARGET-NASH
    First Posted:
    Jun 28, 2016
    Last Update Posted:
    Jul 20, 2022
    Last Verified:
    Jul 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Additional relevant MeSH terms:
    Liver Diseases
    Fatty Liver
    Non-alcoholic Fatty Liver Disease

    Study Results

    No Results Posted as of Jul 20, 2022