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Massive liver study seeks 8,000 volunteers to unlock disease secrets

NCT ID NCT00001971

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 8,050 people

The number the study aims to enrol. It can still change while the study runs.

Started

May 1992

Lead sponsor

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

2 to 100 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show 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.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. 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

  • National Institutes of Health Clinical Center

    RECRUITING

    Bethesda, Maryland, 20892, United States

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