Massive liver study seeks 8,000 volunteers to unlock disease secrets
NCT ID NCT00001971
First seen Jun 27, 2026 · Last updated Sep 11, 2026 · Updated 28 times
Summary
This study aims to learn more about liver diseases like hepatitis B, C, and D by observing up to 8,050 participants over time. Participants will have yearly check-ups, blood and urine tests, and liver ultrasounds. Some may be offered experimental treatments if they qualify. The goal is to better understand how liver disease develops and progresses.
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Study facts
What this study's own registry entry says, in plain language.
- Participants
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About 8,050 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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May 1992
- Lead sponsor
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A government research agency
The lead sponsor is the US National Institutes of Health.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
Who is studied
This is a general clinical research protocol to allow for evaluation, investigation and long-term follow up of patients who have an acute or chronic liver disease. The protocol is designed to study the natural history and pathogenesis of various liver diseases such as acute and chronic hepatitis B, C, D and E, primary biliary cirrhosis, primary sclerosing cholangitis, Wilson's disease, hemochromatosis, nonalcoholic steatohepatitis (NASH), noncirrhotic portal hypertension, hepatocellular carcinoma, and cryptogenic or poorly defined forms of chronic liver disease.
- Ages
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2 to 100 years
- Sex
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Anyone
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
* INCLUSION CRITERIA: Affected Subjects In order to be eligible to participate in this study, an affected participant must meet all of the following criteria: 1. \>=2 years of age. 2. Meets one of the following: 1. Suspected or evidence of acute or chronic liver disease on evaluation by a referring licensed independent practitioner (LIP), OR 2. At risk for acute or chronic liver disease Healthy Volunteers In order to be eligible to participate in this study, a healthy volunteer must meet all of the following criteria: 1. \>= 18 years of age. 2. In good general health as evidenced by medical history EXCLUSION CRITERIA: Affected Participants An affected participant who meets any of the following criteria will be excluded from participation in this study: 1\. History of significant medical illnesses that might interfere with prolonged follow up evaluation Healthy Volunteers A healthy volunteer who meets any of the following criteria will be excluded from participation in this study: 1. Any chronic medical condition, including (but not limited to) heart, kidney, or lung diseases 2. Taking any regular medications or supplements (with the exception of regular multivitamins and/or oral contraceptives) 3. Average alcohol consumption \> 1 drink/day in past 6 months, per self-report 4. History of liver disease (with the exception of neonatal jaundice) 5. History of severe illness, infection or major surgery in the past year 6. History of cancer (with the exception of basal cell carcinoma resected \> 1 year prior to enrollment) 7. BMI \< 18 or BMI \>25 8. Hemoglobin \< 11 (women) or hemoglobin \< 12 (men) 9. ALT \>35 (men) or ALT \>25 (women) 10. Alkaline Phosphatase \>= 150 11. Bilirubin \>2 g/dL 12. HIV positive, Anti-HCV positive, HBsAg positive or Anti-HBc positive 13. Pregnancy 14. Inability to provide informed consent
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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National Institutes of Health Clinical Center
RECRUITINGBethesda, Maryland, 20892, United States
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