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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