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A 5-year Longitudinal Observational Study of Patients With Nonalcoholic Fatty Liver (NAFL) or Nonalcoholic Steatohepatitis (NASH)

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ClinicalTrials.gov Identifier: NCT02815891
Recruitment Status : Recruiting
First Posted : June 28, 2016
Last Update Posted : October 19, 2018
Sponsor:
Information provided by (Responsible Party):
Target PharmaSolutions, Inc.

Study Description
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Brief Summary:
TARGET-NASH is a longitudinal observational cohort study of patients being managed for NAFL or NASH in usual clinical practice. TARGET-NASH will create a research registry of patients with NAFL or NASH within academic and community real-world practices in order to assess the safety and effectiveness of current and future therapies.

Condition or disease
Nonalcoholic Fatty Liver Nonalcoholic Steatohepatitis

Study Design
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Study Type : Observational [Patient Registry]
Estimated Enrollment : 15000 participants
Observational Model: Cohort
Time Perspective: Other
Target Follow-Up Duration: 5 Years
Official Title: A 5-year Longitudinal Observational Study of Patients With Nonalcoholic Fatty Liver (NAFL) or Nonalcoholic Steatohepatitis (NASH)
Study Start Date : July 2016
Estimated Primary Completion Date : July 2021
Estimated Study Completion Date : July 2021

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Outcome Measures
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Primary Outcome Measures :
  1. Establish an understanding of the current natural history of NASH at academic and community medical centers [ Time Frame: up to 5 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 [ Time Frame: up to 5 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 [ Time Frame: up to 5 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 [ Time Frame: up to 5 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 [ Time Frame: up to 5 years ]
  6. Estimate adverse event frequency and severity and describe management practices [ Time Frame: up to 5 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 [ Time Frame: up to 5 years ]

Biospecimen Retention:   Samples With DNA
Patients enrolled in TARGET-NASH will be invited to participate in the Biorepository Specimen Bank (BSB). Blood samples for biomarker and DNA assays will be collected on a voluntary basis and participation in this project will not affect participation in the main study. These samples will be shipped to a central repository for storage to use in future studies. Samples stored at the biorepository will be identified only with the patient's unique study ID number and the date that the sample was obtained. This link between the patient's study ID number and their name will be available only at the site where the samples were obtained.

Eligibility Criteria
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Ages Eligible for Study:   6 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Adults and children with NAFL or NASH who are being seen specifically to address this disease process
Criteria

Inclusion Criteria:

1. Adults and children (age 6 or older) being managed or treated for NAFL or NASH

Exclusion Criteria:

  1. Inability to provide written informed assent/consent
  2. Simultaneous enrollment in another registry, study, or clinical trial where NASH treatment outcomes are reported, except where approved or conducted as an adjunct project of TARGET-NASH
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02815891


Contacts
Contact: Nikki Nicholson nnicholson@targetpharmasolutions.com

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Sponsors and Collaborators
Target PharmaSolutions, Inc.
More Information
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Responsible Party: Target PharmaSolutions, Inc.
ClinicalTrials.gov Identifier: NCT02815891     History of Changes
Other Study ID Numbers: TARGET-NASH
First Posted: June 28, 2016    Key Record Dates
Last Update Posted: October 19, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
Fatty Liver
Non-alcoholic Fatty Liver Disease
Liver Diseases
Digestive System Diseases