NCT00001971

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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
8,050

participants targeted

Target at P75+ for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 27, 1992

Completed
7.7 years until next milestone

First Posted

Study publicly available on registry

January 19, 2000

Completed
6.5 years until next milestone

First Submitted

Initial submission to the registry

July 12, 2006

Completed
Last Updated

May 22, 2026

Status Verified

May 14, 2026

First QC Date

July 12, 2006

Last Update Submit

May 21, 2026

Conditions

Hepatitis DHepatitis CHepatitis BLiver Disease

Keywords

Hepatitis BHepatitis CHepatitis DChronic HepatitisNatural HistoryLiver Disease

Outcome Measures

Primary Outcomes (1)

  • Predisposition and outcomes related to liver disease susceptibility, progression, and treatment response

    Predisposition and outcomes related to liver disease susceptibility, progression, and treatment response

    Annual visits

Study Arms (2)

Healthy individuals

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

Patients

Liver disease patients

Eligibility Criteria

Age2 Years - 100 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

This is a general clinical research protocol to allow for evaluation, investigation and long-term follow up of patients who have an acute or chronic liver disease. The protocol is designed to study the natural history and pathogenesis of various liver diseases such as acute and chronic hepatitis B, C, D and E, primary biliary cirrhosis, primary sclerosing cholangitis, Wilson's disease, hemochromatosis, nonalcoholic steatohepatitis (NASH), noncirrhotic portal hypertension, hepatocellular carcinoma, and cryptogenic or poorly defined forms of chronic liver disease.

You may qualify if:

  • 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

You may not qualify if:

  • Affected Participants
  • An affected participant who meets any of the following criteria will be excluded from participation in this study:
  • \. 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:
  • Any chronic medical condition, including (but not limited to) heart, kidney, or lung diseases
  • Taking any regular medications or supplements (with the exception of regular multivitamins and/or oral contraceptives)
  • Average alcohol consumption \> 1 drink/day in past 6 months, per self-report
  • 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)
  • BMI \< 18 or BMI \>25
  • Hemoglobin \< 11 (women) or hemoglobin \< 12 (men)
  • ALT \>35 (men) or ALT \>25 (women)
  • Alkaline Phosphatase \>= 150
  • +4 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Institutes of Health Clinical Center

Bethesda, Maryland, 20892, United States

RECRUITING

Related Publications (3)

  • Ali RO, Moon MS, Townsend EC, Hill K, Zhang GY, Bradshaw A, Guan H, Hamilton D, Kleiner DE, Auh S, Koh C, Heller T. Exploring the Link Between Platelet Numbers and Vascular Homeostasis Across Early and Late Stages of Fibrosis in Hepatitis C. Dig Dis Sci. 2020 Feb;65(2):524-533. doi: 10.1007/s10620-019-05760-x. Epub 2019 Aug 12.

    PMID: 31407130DERIVED

  • Kefalakes H, Koh C, Sidney J, Amanakis G, Sette A, Heller T, Rehermann B. 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. Gastroenterology. 2019 May;156(6):1805-1819.e9. doi: 10.1053/j.gastro.2019.01.035. Epub 2019 Jan 18.

    PMID: 30664876DERIVED

  • Koh C, Turner T, Zhao X, Minniti CP, Feld JJ, Simpson J, Demino M, Conrey AK, Jackson MJ, Seamon C, Kleiner DE, Kato GJ, Heller T. Liver stiffness increases acutely during sickle cell vaso-occlusive crisis. Am J Hematol. 2013 Nov;88(11):E250-4. doi: 10.1002/ajh.23532. Epub 2013 Aug 1.

    PMID: 23828202DERIVED

Related Links

MeSH Terms

Conditions

Hepatitis DHepatitis CHepatitis BLiver DiseasesHepatitis, Chronic

Condition Hierarchy (Ancestors)

Hepatitis, Viral, HumanVirus DiseasesInfectionsRNA Virus InfectionsHepatitisDigestive System DiseasesBlood-Borne InfectionsCommunicable DiseasesFlaviviridae InfectionsHepadnaviridae InfectionsDNA Virus InfectionsChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • T. Jake Liang, M.D.

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

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Patricia E Alcivar

CONTACT

(301) 435-6121patricia.alcivar@nih.gov

T. Jake Liang, M.D.

CONTACT

(301) 496-1721jakel@mail.nih.gov

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
NIH
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 12, 2006

First Posted

January 19, 2000

Study Start

May 27, 1992

Last Updated

May 22, 2026

Record last verified: 2026-05-14

Data Sharing

IPD Sharing
Will not share

Locations

US(1)