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NCT00001971From ClinicalTrials.govRecruiting

Evaluation of Patients With Liver Disease

  • Hepatitis D
  • Hepatitis C
  • Hepatitis B
  • Liver Disease

At a glance

Phase
Phase not stated
Study type
Observational
Sponsor
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Enrolment target
8,050
Started
27 May 1992
Main results due
Not stated
Study sites
1
Registry updated
24 September 2026

Can you take part?

  • Ages 2 years to 100 years.
  • Open to any sex.
  • Healthy volunteers can take part.

These are the headline rules only. Every study has a longer list, and whether you are eligible is decided by the research team at the site — never by this page.

Read the full eligibility criteria
* 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

What this study is about

In the sponsor’s own words, from the registry.

The proposed study aims to evaluate, investigate, and follow-up patients suffering from acute and chronic liver disease. The study will focus on understanding diseases affecting the liver.

Patients participating in the study will first undergo a routine check-up as an outpatient. They will be asked to provide blood and urine samples for laboratory testing and will undergo an ultrasound of the liver. Ultrasound examinations use sound waves to determine the size and texture of the liver. After the initial visit subjects will be requested to follow-up once a year at the outpatient department for a similar check-up.

Additional tests may be requested throughout the study to provide information for other research studies and individual consent will be requested. These tests may include liver biopsies, skin biopsies, and / or specialized blood, plasma, and lymphocyte examinations.

Subjects that qualify for medications presently being studied may be offered the opportunity to benefit from experimental therapy.

Study sites(1)

  • National Institutes of Health Clinical Center

    Bethesda, Maryland, United States

    Recruiting

Showing 1 of 1 sites. 1 of the 1 site on this study is recruiting right now — a site can stop enrolling while the study as a whole is still open.

Source: ClinicalTrials.gov record NCT00001971. Trialion does not run this study, is not paid to refer anyone to it, and cannot enrol you. Eligibility is always decided by the research team at the site.

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Evaluation of Patients With Liver Disease | Trialion