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Nonalcoholic Fatty Liver Disease (NAFLD) Database 3

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ClinicalTrials.gov Identifier: NCT04454463
Recruitment Status : Recruiting
First Posted : July 1, 2020
Last Update Posted : September 8, 2021
Sponsor:
Information provided by (Responsible Party):
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Brief Summary:
The NAFLD Database 3 will enroll approximately 1500 adult patients and 750 pediatric patients suspected or known to have NAFLD or NASH-related cirrhosis. To elucidate, through the cooperative effort of a multidisciplinary and multicenter group of collaborators, the etiology, natural history, diagnosis, treatment, and prevention of NAFLD, and in particular its more severe form of NASH and its complications.

Condition or disease
Liver Diseases

Detailed Description:
This is a multicenter, prospective follow-up study of patients with known nonalcoholic fatty liver disease (NAFLD) or nonalcoholic steatohepatitis (NASH). The primary objective of the study is to investigate the etiology, pathogenesis, natural history, diagnosis, treatment, and prevention of NAFLD and NASH.

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Study Type : Observational
Estimated Enrollment : 2250 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Nonalcoholic Fatty Liver Disease (NAFLD) Database 3
Actual Study Start Date : November 13, 2020
Estimated Primary Completion Date : June 30, 2024
Estimated Study Completion Date : June 30, 2024


Group/Cohort
Adult patients with NAFLD
1500 patients 18 years and older at the time of enrollment.
Pediatric patients with NAFLD
750 patients 2 years or older and up to 17 years old at the time of enrollment.



Primary Outcome Measures :
  1. Change in alanine aminotransferase (ALT) levels from baseline to one year. [ Time Frame: Baseline and 1 year ]
    ALT measure in IU/L (higher ALT indicates worse outcomes)


Biospecimen Retention:   Samples With DNA
plasma, serum, liver tissue


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   2 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

The study population will be at least 2250 patients age 2 years or older with histologically confirmed NAFLD or NASH located in the United States:

  • 1500 patients 18 years and older at the time of enrollment.
  • 750 patients 2 years or older and up to 17 years old at the time of enrollment.
Criteria

Inclusion Criteria:

  • 2 years of age or older as of the initial screening interview and provision of consent
  • Willingness to participate in the study for 1 or more years
  • Histologic evidence of NAFLD or NASH based upon a standard of care liver biopsy
  • Collection of serum and plasma up to 90 days before or 4- 90 days after standard of care liver biopsy
  • Absence of regular or excessive use of alcohol within 2 years prior to initial screening

Exclusion Criteria:

  • Clinical or histological evidence of alcoholic liver disease: Regular and excessive use of alcohol within the 2 years prior to interview defined as alcohol intake greater than 14 drinks per week in a man or greater than 7 drinks per week in a woman. Approximately 10 g of alcohol equals one 'drink' unit. One unit equals 1 ounce of distilled spirits, one 12-oz beer, or one 4-oz glass of wine
  • Total parenteral nutrition for more than 1 month within a 6-month period before baseline liver biopsy
  • Short bowel syndrome
  • History of gastric or jejunoileal bypass preceding the diagnosis of NAFLD. Bariatric surgery performed following enrollment is not exclusionary. Liver biopsies obtained during bariatric surgery cannot be used for enrollment because of the associated surgical or anesthetic acute changes and the weight loss efforts that precede bariatric surgery
  • History of biliopancreatic diversion
  • Evidence of advanced liver disease defined as a Child-Pugh-Turcotte score equal to or greater than 10
  • Evidence of chronic hepatitis B as marked by the presence of HBsAg in serum (patients with isolated antibody to hepatitis B core antigen, anti-HBc total, are not excluded)
  • Evidence of chronic hepatitis C as marked by the presence of anti-HCV or HCV RNA in serum
  • Low alpha-1-antitrypsin level and ZZ phenotype (both determined at the discretion of the investigator)
  • Wilson's disease
  • Known glycogen storage disease
  • Known dysbetalipoproteinemia
  • Known phenotypic hemochromatosis (HII greater than 1.9 or removal of more than 4 g of iron by phlebotomy)
  • Prominent bile duct injury (florid duct lesions or periductal sclerosis) or bile duct paucity
  • Chronic cholestasis
  • Vascular lesions (vasculitis, cardiac sclerosis, acute or chronic Budd-Chiari, hepatoportal sclerosis, peliosis)
  • Iron overload greater than 3+
  • Zones of confluent necrosis, infarction, massive or sub-massive, pan-acinar necrosis
  • Multiple epithelioid granulomas
  • Congenital hepatic fibrosis
  • Polycystic liver disease
  • Other metabolic or congenital liver disease
  • Evidence of systemic infectious disease
  • Known HIV positive
  • Disseminated or advanced malignancy
  • Concomitant severe underlying systemic illness that in the opinion of the investigator would interfere with completion of follow-up
  • Active drug use or dependence that, in the opinion of the study investigator, would interfere with adherence to study requirements
  • Any other condition, which in the opinion of the investigator would impede compliance or hinder completion of study
  • Inability to complete the appropriate informed consent process

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): NCT04454463


Contacts
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Contact: Peggy Adamo, BS 410-502-9137 madamo1@jhu.edu
Contact: Emily Sharkey, MPH 410-955-8183 esharke5@jhu.edu

Locations
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United States, California
University of California, San Diego- Adults Recruiting
La Jolla, California, United States, 92103
Contact: Egbert Madamba    858-246-2227    emadamba@health.ucsd.edu   
Contact: Lori Edge    (858) 246-5333    ledge@health.ucsd.edu   
Principal Investigator: Rohit Loomba, MD         
University of Southern California Recruiting
Los Angeles, California, United States, 90089
Contact: Daisy Olvera    323-442-0535    daisy.olvera@med.usc.edu   
Principal Investigator: Norah Terrault, MD, MPH         
University of California, San Diego Pediatrics Recruiting
San Diego, California, United States, 92103
Contact: Janis Durelle    619-543-5226    jdurelle@ucsd.edu   
Contact: Carissa Carrier    (619) 543-7537    ccarrier@health.ucsd.edu   
Principal Investigator: Jeffrey Schwimmer, MD         
University of California, San Francisco Recruiting
San Francisco, California, United States, 94143
Contact: Rae Davis    415-514-3274    rayshawnda.davis@ucsf.edu   
Contact: Remi Awe    (415) 502-2906    remilekun.awe@ucsf.edu   
Principal Investigator: Norah Terrault, MD         
Sub-Investigator: Bilal Hameed, MD         
United States, Georgia
Emory University-Pediatrics Recruiting
Atlanta, Georgia, United States, 30322
Contact: Rebecca Cleeton    404-727-5383    rcleeto@emory.edu   
Contact: Julia Tisheh    (404) 727-5383    julia.tisheh@emory.edu   
Principal Investigator: Miriam Vos, MD, PhD         
United States, Illinois
Ann & Robert H. Lurie Children's Hospital of Chicago Recruiting
Chicago, Illinois, United States, 60614
Contact: Mary Riordan    312-227-4558    mriordan@luriechildrens.org   
Contact: Angela Anthony    (312) 227-4559    aanthony@luriechildrens.org   
Principal Investigator: Mark Fishbein, MD         
United States, Indiana
Indiana University- Adults Recruiting
Indianapolis, Indiana, United States, 46202
Contact: Jessie Vaughn, BSN    317-274-8427    jevaugh@iu.edu   
Contact: Kayte Sutton    (317) 278-4554    kpsutton@iu.edu   
Principal Investigator: Naga Chalasani, MD         
Riley Hospital for Children Recruiting
Indianapolis, Indiana, United States, 46202
Contact: Laura Carr, RN    317-944-4490    walkerlk@iu.edu   
Contact: Wendy Morlan    (317) 274-9601    wmorlan@iu.edu   
Principal Investigator: Jean Molleston, MD         
United States, Missouri
St. Louis University Recruiting
Saint Louis, Missouri, United States, 63110
Contact: Theresa Cattoor, RN    314-977-9355    theresa.cattooor@health.slu.edu   
Contact: Shirley Campbell    (314) 977-9336    shirley.campbell@health.slu.edu   
Principal Investigator: Brent Tetri, MD         
Sub-Investigator: Ajay Jain, MD         
United States, North Carolina
Duke University Medical Center Recruiting
Durham, North Carolina, United States, 27710
Contact: Mariko Kopping    919-684-4798    mariko.kopping@duke.edu   
Principal Investigator: Anna Mae Diehl, MD         
Sub-Investigator: Manal Abdelmalek, MD         
United States, Ohio
Cincinnati Children's Hospital Medical Center Recruiting
Cincinnati, Ohio, United States, 45229-3039
Principal Investigator: Stavra Xanthakos, MD         
Sub-Investigator: Marialena Mouzaki, MD         
Cleveland Clinic Foundation Recruiting
Cleveland, Ohio, United States, 44195
Contact: Rahul Yerrapothu    216-445-4863    yerrapr@ccf.org   
Contact: Annette Bellar    (216) 636-5247    bellara@ccf.org   
Principal Investigator: Srinivasan Dasarathy, MD         
United States, Texas
Texas Children's Hospital, Baylor University Recruiting
Houston, Texas, United States, 77030
Contact: Diego Olvera    832-824-0978    diego.olvera@bcm.edu   
Contact: Cynthia Tsai    (832) 822-3634    ct2@bcm.edu   
Principal Investigator: Paula Hertel, MD         
United States, Virginia
Virginia Commonwealth University Recruiting
Richmond, Virginia, United States, 23298
Contact: Sherry Boyett    804-828-5434    sherry.boyett@vcuhealth.org   
Contact: Jolene Schlosser    (804) 828-9195    jolene.schlosser@vcuhealth.org   
Principal Investigator: Arun J Sanyal, MD         
United States, Washington
Liver Institute Northwest Recruiting
Seattle, Washington, United States, 98105
Contact: Luiza Deftu    206-536-3030    ldeftu@liverinstitutenw.org   
Contact: Heather Harris    (206) 536-3030    hharris@liverinstitutenw.org   
Principal Investigator: Kris Kowdley, MD         
Seattle Children's Hospital- SEA Recruiting
Seattle, Washington, United States, 98105
Contact: Melissa Young    206-987-1037    melissa.young@seattlechildrens.org   
Contact: Kara Cooper    (206) 987-4636    kara.cooper@seattlechildrens.org   
Principal Investigator: Niviann Blondet, MD         
Sponsors and Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Investigators
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Principal Investigator: Arun Sanyal, MD Virginia Commonwealth University Medical Center
Principal Investigator: Brent Tetri, MD St Louis University Hospital
Additional Information:
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Responsible Party: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
ClinicalTrials.gov Identifier: NCT04454463    
Other Study ID Numbers: NAFLD Database 3
U01DK061732 ( U.S. NIH Grant/Contract )
U01DK061713 ( U.S. NIH Grant/Contract )
U01DK061737 ( U.S. NIH Grant/Contract )
U01DK061718 ( U.S. NIH Grant/Contract )
U01DK061734 ( U.S. NIH Grant/Contract )
U01DK061738 ( U.S. NIH Grant/Contract )
U01DK061728 ( U.S. NIH Grant/Contract )
U01DK061731 ( U.S. NIH Grant/Contract )
U24DK061730 ( U.S. NIH Grant/Contract )
First Posted: July 1, 2020    Key Record Dates
Last Update Posted: September 8, 2021
Last Verified: August 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: The NASH CRN is fully committed to resource sharing beyond the NASH CRN investigators. The NASH CRN will make deposits to the NIDDK Central Data Repository according to the requirements outlined in the NIDDK Data Sharing Policy published in July 2013.
Supporting Materials: Study Protocol
Informed Consent Form (ICF)
Analytic Code
Time Frame: Within two years of end of the funding cycle.
Access Criteria: All qualified investigators will be allowed access to the stored materials at the end of a pre-determined proprietary period.
URL: https://repository.niddk.nih.gov/home/

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK):
NAFLD
NASH
non-alcoholic steatohepatitis
fatty liver disease
Additional relevant MeSH terms:
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Liver Diseases
Fatty Liver
Non-alcoholic Fatty Liver Disease
Digestive System Diseases