History of Changes for Study: NCT04454463

Nonalcoholic Fatty Liver Disease (NAFLD) Database 3

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Study Record Versions

Version	Submitted Date	Changes
1	June 30, 2020	None (earliest Version on record)
2	November 12, 2020	Recruitment Status, Study Status and Contacts/Locations
3	November 18, 2020	Study Status
4	February 5, 2021	Contacts/Locations and Study Status
5	April 23, 2021	Study Status, Contacts/Locations and Study Description
6	August 31, 2021	Contacts/Locations, Study Status and Study Description
7	January 28, 2022	Study Status and Sponsor/Collaborators
8	February 17, 2022	Sponsor/Collaborators, Study Identification and Study Status
9	February 7, 2023	Contacts/Locations and Study Status
10	July 10, 2023	Study Status
11	February 9, 2024	Study Status

Comparison Format:

Merged
Side-by-Side

Study Identification


Unique Protocol ID:	NAFLD Database 3
Brief Title:	Nonalcoholic Fatty Liver Disease (NAFLD) Database 3
Official Title:	Nonalcoholic Fatty Liver Disease (NAFLD) Database 3
Secondary IDs:	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]

Study Status


Record Verification:	June 2020
Overall Status:	Not yet recruiting
Study Start:	August 1, 2020
Primary Completion:	June 30, 2024 [Anticipated]
Study Completion:	June 30, 2024 [Anticipated]

First Submitted:	June 5, 2020
First Submitted that Met QC Criteria:	June 30, 2020
First Posted:	July 1, 2020 [Actual]

Last Update Submitted that Met QC Criteria:	June 30, 2020
Last Update Posted:	July 1, 2020 [Actual]

Sponsor/Collaborators


Sponsor:	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Responsible Party:	Sponsor
Collaborators:

Oversight


U.S. FDA-regulated Drug:	No
U.S. FDA-regulated Device:	No
Data Monitoring:	Yes

Study Description

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.

Detailed Description:

To enroll at least 2250 patients (1500 adult patients and 750 pediatric patients) with a diagnosis of NAFLD, supported by a standard of care liver biopsy, with a broad range of severity. Core data collection will include clinical, demographic, laboratory, imaging, and histological features
To increase the population diversity of the NAFLD Database 2 to provide greater representation of Hispanic, Native American, African American, and Asian patients recruited into the NAFLD Database 3
To expand the current specimen bank comprised of liver tissue, serum, plasma, and DNA obtained from patients undergoing a liver biopsy with the specific goal of optimizing the collection of plasma or serum suitable for biomarker development studies by obtaining specimens in close temporal proximity to the performance of liver biopsy

Conditions


Conditions:	Liver Diseases
Keywords:	NAFLD NASH non-alcoholic steatohepatitis fatty liver disease

Study Design


Study Type:	Observational
Observational Study Model:	Cohort
Time Perspective:	Prospective
Biospecimen Retention:	Samples With DNA
Biospecimen Description:	plasma, serum, liver tissue
Enrollment:	2250 [Anticipated]
Number of Groups/Cohorts	2

Groups and Interventions

Groups/Cohorts	Interventions
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.

Outcome Measures


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)

Eligibility


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.
Sampling Method:	Non-Probability Sample
Minimum Age:	2 Years
Maximum Age:
Sex:	All
Gender Based:
Accepts Healthy Volunteers:	No
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

Contacts/Locations


Central Contact Person:	Margaret Adamo, NP, MS Telephone: 410-502-9137 Email: madamo1@jhu.edu
Central Contact Backup:	Emily Sharkey, BS Telephone: 410-955-8183 Email: esharke5@jhu.edu
Study Officials:	Arun Sanyal, MD Principal Investigator Virginia Commonwealth University Medical Center
	Brent Tetri, MD Principal Investigator St Louis University Hospital
Locations:	United States, California
	University of California, San Diego- Adults La Jolla, California, United States, 92103 Contact:Contact: Carolyn Hernandez 619-471-0774 c1hernandez@ucsd.edu Contact:Principal Investigator: Rohit Loomba, MD
	University of Southern California Los Angeles, California, United States, 90089 Contact:Contact: Christy Rico 323-442-1100 Christy.Rico@med.usc.edu Contact:Principal Investigator: Norah Terrault, MD, MPH
	University of California, San Diego Pediatrics San Diego, California, United States, 92103 Contact:Contact: Janis Durelle 619-543-5226 jdurelle@ucsd.edu Contact:Principal Investigator: Jeffrey Schwimmer, MD
	University of California, San Francisco San Francisco, California, United States, 94143 Contact:Contact: Danielle Brandman, MD 415-514-1094 danielle.brandman@ucsf.edu Contact:Principal Investigator: Norah Terrault, MD
	United States, Georgia
	Emory University-Pediatrics Atlanta, Georgia, United States, 30322
	United States, Illinois
	Ann & Robert H. Lurie Children's Hospital of Chicago (NWU) Chicago, Illinois, United States, 60614 Contact:Contact: Mary Riordan 312-227-4558 mriordan@luriechildrens.org Contact:Principal Investigator: Mark Fishbein, MD
	United States, Indiana
	Indiana University- Adults Indianapolis, Indiana, United States, 46202 Contact:Contact: Regina Weber 317-278-3584 ginaw@iu.edu Contact:Principal Investigator: Naga Chalasani, MD
	Riley Hospital for Children Indianapolis, Indiana, United States, 46202 Contact:Contact: Laura Carr, RN 317-944-4490 walkerlk@iu.edu Contact:Principal Investigator: Jean Molleston, MD
	United States, Missouri
	St. Louis University Saint Louis, Missouri, United States, 63110 Contact:Contact: Theresa Cattoor 314-977-5239 theresa.cattooor@health.slu.edu Contact:Contact: Ajay Jain, MJD (314) 577-5647 ajay.jain@health.slu.edu Contact:Principal Investigator: Brent Tetri, MD Contact:Sub-Investigator: Ajay Jain, MD
	United States, North Carolina
	Duke University Medical Center Durham, North Carolina, United States, 27710
	United States, Ohio
	Cincinnati Children's Hospital Medical Center Cincinnati, Ohio, United States, 45229-3039 Contact:Contact: April Carr 513-636-3195 april.carr@cchmc.org Contact:Principal Investigator: Stavra Xanthakos, MD Contact:Sub-Investigator: Marialena Mouzaki, MD
	Cleveland Clinic Foundation Cleveland, Ohio, United States, 44195 Contact:Contact: Alina Tuladhar 216-445-0688 tuladha@ccf.org Contact:Contact: Annette Bellar (216) 636-5247 bellara@ccf.org Contact:Principal Investigator: Srinivasan Dasarathy, MD
	United States, Texas
	Texas Children's Hospital Houston, Texas, United States, 77030
	United States, Virginia
	Virginia Commonwealth University Richmond, Virginia, United States, 23298
	United States, Washington
	Liver Institute Northwest Seattle, Washington, United States, 98105 Contact:Contact: Erin Gettman 206-215-2980 erin@liverinstitutenw.org Contact:Principal Investigator: Kris Kowdley, MD
	Seattle Children's Hospital- SEA Seattle, Washington, United States, 98105 Contact:Contact: Melissa Young 206-987-1037 melissa.young@seattlechildrens.org Contact:Principal Investigator: Niviann Blondet, MD

IPDSharing


Plan to Share IPD:	Yes 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 Information: 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/

References


Citations:
Links:	URL: http://jhuccs1.us/nash/ Description: Nonalcoholic Steatohepatitis Clinical Research Consortium
	URL: http://www2.niddk.nih.gov/ Description: The National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Available IPD/Information: