Actively Recruiting

Age: 2Years - 100Years
All Genders
Healthy Volunteers
ID00001971

Evaluation of Patients With Liver Disease

Led by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) · Updated on 2026-05-22

8050

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are investigating acute and chronic liver diseases by collecting data and samples from affected patients and healthy volunteers. The study aims to understand various liver conditions such as hepatitis B, C, D, and E, primary biliary cirrhosis, Wilson's disease, hemochromatosis, nonalcoholic steatohepatitis, and others. This observational research seeks to explore the natural history and genetic factors that may influence liver disease susceptibility, progression, and treatment outcomes. Participants include both healthy individuals and patients with liver diseases. Initial evaluations involve routine outpatient check-ups with blood and urine tests and liver ultrasounds to assess liver size and texture. Follow-up visits occur annually to repeat these assessments. Additional tests like liver or skin biopsies and specialized blood analyses may be requested with individual consent. Some participants qualifying for experimental treatments may have the opportunity to receive investigational therapies during the study. Throughout the study, participants provide various biological samples, including blood, saliva, urine, stool, and tissue from clinically indicated biopsies. Genetic testing is also performed to study inherited factors related to liver diseases. Primary outcomes focus on liver disease susceptibility, progression, and response to treatment, monitored during yearly visits. The study involves long-term follow-up to gather comprehensive clinical and laboratory data, helping to inform future research and potential therapies.

CONDITIONS

Brief Title

Evaluation of Patients With Liver Disease

Who Can Participate

Age: 2Years - 100Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Affected participants must be 2 years or older
  • Have suspected or confirmed acute or chronic liver disease, or be at risk for such diseases
  • Healthy volunteers must be 18 years or older
  • Healthy volunteers must be in good general health based on medical history
Not Eligible

You will not qualify if you...

  • Affected participants with significant medical illnesses that could interfere with long-term follow-up
  • Healthy volunteers with any chronic medical conditions such as heart, kidney, or lung diseases
  • Healthy volunteers taking regular medications or supplements except multivitamins or oral contraceptives
  • Healthy volunteers with alcohol consumption greater than 1 drink per day in the past 6 months
  • Healthy volunteers with a history of liver disease except neonatal jaundice
  • Healthy volunteers with recent severe illness, infection, or major surgery within the past year
  • Healthy volunteers with history of cancer except basal cell carcinoma removed more than 1 year ago
  • Healthy volunteers with body mass index (BMI) less than 18 or greater than 25
  • Healthy volunteers with low hemoglobin levels (less than 11 for women, less than 12 for men)
  • Healthy volunteers with elevated liver enzymes or bilirubin
  • Healthy volunteers positive for HIV, hepatitis B or C markers
  • Pregnancy
  • Inability to provide informed consent

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

Clinical Evaluation and Sample Collection

Duration - Occurs during routine clinical care

Participants undergo clinical evaluation and provide samples such as blood, saliva, urine, stool, and tissue obtained during clinically-indicated liver biopsies for research purposes.

Long-term Monitoring

Duration - Ongoing with annual visits

Participants are followed over time with annual visits to collect data and samples for studying liver disease susceptibility, progression, and treatment response.

Annual visits

Trial Site Locations

Total: 1 location

1

National Institutes of Health Clinical Center

Bethesda, Maryland, United States, 20892

Actively Recruiting

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Research Team

P

Patricia E Alcivar

T

T. Jake Liang, M.D.

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

2

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Published Research Related To This Trial

Exploring the Link Between Platelet Numbers and Vascular Homeostasis Across Early and Late Stages of Fibrosis in Hepatitis C.

Rabab O Ali, Mi Sun Moon, Elizabeth C Townsend...

https://pubmed.ncbi.nlm.nih.gov/31407130

Hepatitis D Virus-Specific CD8+ T Cells Have a Memory-Like Phenotype Associated With Viral Immune Escape in Patients With Chronic Hepatitis D Virus Infection.

Helenie Kefalakes, Christopher Koh, John Sidney...

https://pubmed.ncbi.nlm.nih.gov/30664876