Evaluation of patients with liver disease

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study aims to evaluate and follow patients with acute and chronic liver diseases, including hepatitis B, C, and D. Participants will undergo routine check-ups, including blood and urine tests, and liver ultrasounds. They will be followed up annually for similar evaluations, with additional tests such as biopsies and genetic analyses potentially requested. The goal is to collect data and samples to better understand the natural history and pathogenesis of liver diseases.

Why it matters

Who can join: the full rules

* 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

Where it's running

• National Institutes of Health Clinical Center
  Bethesda, Maryland, United States Recruiting

Study contacts

• Principal investigator: T. Jake Liang, M.D. — National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
• Study coordinator: Patricia E Alcivar
• Email: patricia.alcivar@nih.gov
• Phone: (301) 435-6121

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.