Evaluation of patients with liver disease

This study is trying to learn more about liver diseases by checking in on patients with conditions like hepatitis B, C, and D through regular tests and follow-ups.

Quick facts

• Study type: Observational
• Enrollment: 8050 (estimated)
• Ages: 2 Years to 100 Years
• Sex: All
• Sponsor: National Institutes of Health Clinical Center (CC) (NIH)
• Locations: 1 site (Bethesda, Maryland)
• Trial ID: NCT00001971 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates include individuals aged 2 years and older with suspected or confirmed acute or chronic liver disease.

Not a fit: Patients with significant medical illnesses that could interfere with prolonged follow-up evaluations may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved understanding and treatment options for patients with liver diseases.

How similar studies have performed: Other studies have successfully utilized similar observational approaches to understand liver diseases, indicating potential for valuable insights.

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

Where this trial is running

Bethesda, Maryland

• 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

Conditions Hepatitis D; Hepatitis C; Hepatitis B; Liver Disease; Chronic Hepatitis; Natural History