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Following People With Liver Disease Over Time With Check-Ups

Follows people with acute or chronic liver disease through yearly check-ups and tests.

Key facts

Who runs it
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Where
Bethesda, United StatesSee the site
Trial code
Registry title
Evaluation of Patients With Liver Disease
Status
Recruiting
People taking part
8,050 people, planned
Started
27 May 1992
Type of study
Observational, 2 groups
Record updated
12 November 2026

Who can take part

Age
2 years to 100 years
Sex
Women and men
Healthy volunteers
Can take part

The registry criteria, word for word

Show all 22 criteriaShow less

Who cannot take part

  • Taking any regular medications or supplements (with the exception of regular multivitamins and/or oral contraceptives)
  • 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:
  • Any chronic medical condition, including (but not limited to) heart, kidney, or lung diseases
  • History of liver disease (with the exception of neonatal jaundice)
  • History of severe illness, infection or major surgery in the past year
  • History of cancer (with the exception of basal cell carcinoma resected > 1 year prior to enrollment)
  • HIV positive, Anti-HCV positive, HBsAg positive or Anti-HBc positive
  • Hemoglobin < 11 (women) or hemoglobin < 12 (men)
  • ALT >35 (men) or ALT >25 (women)
  • Alkaline Phosphatase >= 150
  • Bilirubin >2 g/dL
  • Affected Participants
  • An affected participant who meets any of the following criteria will be excluded from participation in this study:
  • Average alcohol consumption > 1 drink/day in past 6 months, per self-report
  • BMI < 18 or BMI >25
  • Pregnancy
  • Inability to provide informed consent

Other 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:
  • >=2 years of age
  • Meets one of the following:; Suspected or evidence of acute or chronic liver disease on evaluation by a referring licensed independent practitioner (LIP), OR; 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:
  • >= 18 years of age
  • In good general health as evidenced by medical history

Check if you might fit

Answer for yourself. This is not a decision: only the study team can say whether you can take part.

  • Are you between 2 and 100 years old?

Where in United States

  • National Institutes of Health Clinical CenterBethesda, United StatesContact: Patricia E AlcivarTaking people

About the trial

What the trial wants to find out

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.

Read full original descriptionShow less

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....

The 2 groups in the trial

  • Healthy individuals

    Healthy individuals who have recovered from liver diseases or who are healthy volunteers

  • Patients

    Liver disease patients

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov.
Official title
Evaluation of Patients With Liver Disease
Plain-language title
Following People With Liver Disease Over Time With Check-UpsGenerated from the registry record. The registry title is the official one.
Fit questions
Built from NCT00001971, who can take part
Record updated
12 November 2026