NCT00001971Recruiting
Evaluation of Patients With Liver Disease
Source: ClinicalTrials.gov · Last updated 3 Nov 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 8050 (estimated)
- First submitted
- 12 Jul 2006
- Start date
- 27 May 1992
- Lead sponsor
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Diseases
- Hepatitis B
- NCT number
- NCT00001971
What you commit to
- Study type: Observational
- Planned participants: 8050
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Taking any regular medications or supplements (with the exception of regular multivitamins and/or oral contraceptives)
Other illness
- 1\. History of significant medical illnesses that might interfere with prolonged follow up evaluation
- 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
Lab values
- Hemoglobin \< 11 (women) or hemoglobin \< 12 (men)
- ALT \>35 (men) or ALT \>25 (women)
- Alkaline Phosphatase \>= 150
- Bilirubin \>2 g/dL
Other
- Affected Participants
- An affected participant who meets any of the following criteria will be excluded from participation in this study:
- Healthy Volunteers
- A healthy volunteer 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
Criteria the registry did not label
- 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
Age in the registry: 2 years to 100 years · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| National Institutes of Health Clinical Center Coordinator of this site? Confirm its status | Bethesda | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.