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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02815891
Recruitment Status : Recruiting
First Posted : June 28, 2016
Last Update Posted : December 5, 2019
Sponsor:
Information provided by (Responsible Party):
Target PharmaSolutions, Inc.

Tracking Information
First Submitted Date June 23, 2016
First Posted Date June 28, 2016
Last Update Posted Date December 5, 2019
Study Start Date July 2016
Estimated Primary Completion Date July 2026   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: June 23, 2016)
  • 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.
  • 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.
  • 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.
  • 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.
  • Examine liver histology [ Time Frame: up to 5 years ]
  • 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).
  • Evaluate the impact of NASH therapies on medical co-morbidities [ Time Frame: up to 5 years ]
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT02815891 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title A 5-year Longitudinal Observational Study of Patients With Nonalcoholic Fatty Liver (NAFL) or Nonalcoholic Steatohepatitis (NASH)
Official Title A 5-year Longitudinal Observational Study of Patients With Nonalcoholic Fatty Liver (NAFL) or Nonalcoholic Steatohepatitis (NASH)
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.
Detailed Description Not Provided
Study Type Observational [Patient Registry]
Study Design Observational Model: Cohort
Time Perspective: Other
Target Follow-Up Duration 5 Years
Biospecimen Retention:   Samples With DNA
Description:
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.
Sampling Method Non-Probability Sample
Study Population Adults and children with NAFL or NASH who are being seen specifically to address this disease process
Condition
  • Nonalcoholic Fatty Liver
  • Nonalcoholic Steatohepatitis
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: June 23, 2016)
15000
Original Estimated Enrollment Same as current
Estimated Study Completion Date July 2026
Estimated Primary Completion Date July 2026   (Final data collection date for primary outcome measure)
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 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. If a participant elects to enroll in an interventional clinical trial during their enrollment in TARGET-NASH, records submissions for the participant will be put 'on hold' for the trial duration. When participation in the trial is complete, records submissions for TARGET-NASH will resume.
Sex/Gender
Sexes Eligible for Study: All
Ages 2 Years and older   (Child, Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
Contact: Jonathan Durlam jdurlam@targetpharmasolutions.com
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT02815891
Other Study ID Numbers TARGET-NASH
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party Target PharmaSolutions, Inc.
Study Sponsor Target PharmaSolutions, Inc.
Collaborators Not Provided
Investigators Not Provided
PRS Account Target PharmaSolutions, Inc.
Verification Date December 2019