Liver DiseasesNCT04454463
Nonalcoholic Fatty Liver Disease (NAFLD) Database 3
An observational study of Liver Diseases, run by Johns Hopkins Bloomberg School of Public Health at 16 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 2 years and older
- Conditions the study is for
- Liver Diseases
- How many people
- 1,649 participants
- Where
- 16 sitesUnited States
- Study dates
- 13 Nov 2020to 9 Jul 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Show all 29Show fewer
- 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
Trial locations and contacts
16 sites in 1 country.
16 sites in 1 country
United States16 sites
Emory University-Pediatrics
Atlanta, Georgia, 30322
Ann & Robert H. Lurie Children's Hospital of Chicago
Chicago, Illinois, 60614
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, 45229-3039
Cleveland Clinic Foundation
Cleveland, Ohio, 44195
Duke University Medical Center
Durham, North Carolina, 27710
Texas Children's Hospital, Baylor University
Houston, Texas, 77030
Indiana University- Adults
Indianapolis, Indiana, 46202
Riley Hospital for Children
Indianapolis, Indiana, 46202
University of California, San Diego- Adults
La Jolla, California, 92103
University of Southern California
Los Angeles, California, 90089
Virginia Commonwealth University
Richmond, Virginia, 23298
University of California, San Diego Pediatrics
San Diego, California, 92103
University of California, San Francisco
San Francisco, California, 94143
Liver Institute Northwest
Seattle, Washington, 98105
Seattle Children's Hospital- SEA
Seattle, Washington, 98105
St. Louis University
St Louis, Missouri, 63110
About this study
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.
Read the 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.
- Conditions
- Liver Diseases
- Keywords
- NAFLD, NASH, non-alcoholic steatohepatitis, fatty liver disease
- Medical subject headings
- Liver Diseases, Non-alcoholic Fatty Liver Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in alanine aminotransferase (ALT) levels from baseline to one year.
ALT measure in IU/L (higher ALT indicates worse outcomes)
Measured: Baseline and 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2020
- Study start13 Nov 2020
- Primary completion9 Jul 2025
- Study completion9 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Liver DiseasesStudies of the same condition, open and under way.
- More trials run by Johns Hopkins Bloomberg School of Public HealthThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,649 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins Bloomberg School of Public Health
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), Baylor College of Medicine, Case Western Reserve University, Duke University, Ann & Robert H Lurie Children's Hospital of Chicago, Indiana University, Liver Institute Northwest, Seattle Children's Hospital, St. Louis University, University of California, San Diego, University of California, San Francisco, University of Southern California, Virginia Commonwealth University, Emory University, Children's Hospital Medical Center, Cincinnati
- Responsible party
- Sponsor
- Investigators
- Arun Sanyal, MD, Principal investigator, Virginia Commonwealth University Medical CenterBrent Tetri, MD, Principal investigator, St Louis University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04454463
- Sponsor's protocol ID
- NAFLD Database 3
- Other IDs
- U01DK061732, U01DK061713, U01DK061737, U01DK061718, U01DK061734, U01DK061738, U01DK061728, U01DK061731
- Status last verified
- Aug 2025
- First submitted
- 5 Jun 2020
- Last updated
- 13 Aug 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nonalcoholic Fatty Liver Disease (NAFLD) Database 3
- ClinicalTrials.gov ID
- NCT04454463
- Acronym / sponsor ID
- NAFLD Database 3
- Conditions
- Liver Diseases
- Keywords
- NAFLD, NASH, non-alcoholic steatohepatitis, fatty liver disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,649 participants (actual)
- Lead sponsor
- Johns Hopkins Bloomberg School of Public HealthUniversity, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), Baylor College of Medicine, Case Western Reserve University, Duke University, Ann & Robert H Lurie Children's Hospital of Chicago, Indiana University, Liver Institute Northwest, Seattle Children's Hospital, St. Louis University, University of California, San Diego, University of California, San Francisco, University of Southern California, Virginia Commonwealth University, Emory University, Children's Hospital Medical Center, Cincinnati
- Study start
- 13 Nov 2020 (actual)
- Primary completion
- 9 Jul 2025 (actual)
- Study completion
- 9 Jul 2025 (actual)
- First posted
- 1 Jul 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 2 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (29 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2025.
- Nonalcoholic Steatohepatitis Clinical Research ConsortiumLink provided by the sponsor.
- NIDDK Central RepositoryLink provided by the sponsor.
- Individual participant dataSharing planned: 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.
Related trials for Liver Diseases
Recruiting
Distance-Based Exercise to Preserve Function and Prevent Disability
Localized Malignant Solid Neoplasm, Anal Cancer
Not yet recruitingPhase 2
Effects of Meal Macronutrients on Postprandial Lipids
Nephrotic Syndrome, Lipodystrophy
Not yet recruitingObservational study
Prevalence and Development of Liver Dysfunction in Hematopoietic Stem Cell Transplant
Hematopoietic Stem Cell Transplant
Not yet recruiting
Personalized Dietary Feedback to Reduce Hepatic Steatosis in Patients With MASLD
MASLD (Metabolic Dysfunction-Associated Steatotic Liver Disease), MetALD
Active, not recruiting
Online Prehabilitation for Patients Awaiting Liver Transplantation
Cirrhosis, Liver, Liver Transplant Surgery
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Arun Sanyal, MD principal investigator
Virginia Commonwealth University Medical Center
Brent Tetri, MD principal investigator
St Louis University Hospital
16 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Liver Diseases, run by Johns Hopkins Bloomberg School of Public Health at 16 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 29 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 16 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in alanine aminotransferase (ALT) levels from baseline to one year. (time frame: Baseline and 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Aug 2025.