Recruiting

Liver Disease Evaluation

Sponsor:

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Code:

NCT00001971

Conditions

Hepatitis D

Hepatitis C

Hepatitis B

Liver Disease

Eligibility Criteria

Sex: All

Age: 2 - 70+

Healthy Volunteers: Accepted

Study Details

Brief summary:

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.

Conditions

Hepatitis D

Hepatitis C

Hepatitis B

Liver Disease

Study ID

NCT00001971

Start date

May 27, 1992

Status verified date

Sep 2, 2026

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 2 - 70+

Healthy Volunteers: Accepted

  • 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

Study Design

Enrollment

8050 participants

Anticipated

Interventions and Outcome Measures

Arms

Healthy individuals

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

Patients

Liver disease patients

Primary outcome measure

  • Predisposition and outcomes related to liver disease susceptibility, progression, and treatment response [ Time Frame: Annual visits ]

Central Contacts and Locations

Central contacts

Locations

National Institutes of Health Clinical Center

Recruiting

Bethesda, Maryland, United States, 20892

More Information

Sponsor

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Last update posted

Sep 8, 2026

Last verified

Sep 2, 2026

Keywords

  • Hepatitis B
  • Hepatitis C
  • Hepatitis D
  • Chronic Hepatitis
  • Natural History
  • Liver Disease

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) on 2026-09-08.