Recruiting

Sample and Data Collection in Liver Disease Patients

0 criteria met from your profileSee at a glance how your profile meets each eligibility criteria.
What is being collected

Data Collection

Collected from today forward - Prospective
Who is being recruted

Blood-Borne Infections+17

+ Chronic Disease

+ Communicable Diseases

From 2 to 100 Years
+19 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Cohort

Tracking disease incidence in order to identify risk factors and understand disease progression over time.
Observational
Study Start: May 1992
See protocol details

Summary

Principal SponsorNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Study ContactPatricia E AlcivarMore contacts
Last updated: July 23, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: May 27, 1992

Actual date on which the first participant was enrolled.

Study Description: This is a clinical research protocol to allow for collection of samples and data obtained during clinical evaluation and long-term follow up of patients who have an acute or chronic liver disease. The protocol is designed to create a repository 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. Samples collected during the course of clinical care for patients with liver disease include blood, saliva, urine, stool, and residual tissue obtained during clinically-indicated liver biopsies not otherwise needed for clinical care. Additionally, subjects with liver disease will be asked to provide a blood sample for genetic analysis. Healthy volunteers will be recruited and asked to provide a blood sample to serve as controls for the genetic analyses. Research will be conducted to investigate genetic factors that may contribute to liver diseases Objectives: Primary Objective To collect data and samples during clinical evaluation, treatment and follow-up of participants for future use in studies of liver diseases Secondary Objective To determine if genetic factors may contribute to the susceptibility, progression, outcome, or treatment success of different liver diseases.

NCT00001971
Principal SponsorNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Study ContactPatricia E AlcivarMore contacts
Last updated: July 23, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

8050 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Cohort

These studies follow a group of individuals with common characteristics (such as a condition or birth year) over a specific period to study health outcomes or exposures.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 2 to 100 Years

Range of ages for which participants are eligible to join.

Healthy volunteers allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Blood-Borne InfectionsChronic DiseaseCommunicable DiseasesDigestive System DiseasesDNA Virus InfectionsHepatitisHepatitis, Viral, HumanInfectionsPathologic ProcessesRNA Virus InfectionsPathological Conditions, Signs and SymptomsVirus DiseasesFlaviviridae InfectionsHepadnaviridae InfectionsDisease AttributesHepatitis DHepatitis BHepatitis, ChronicHepatitis CLiver Diseases

Criteria

4 inclusion criteria required to participate
>= 2 years of age

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

>= 18 years of age

In good general health as evidenced by medical history

15 exclusion criteria prevent from participating
History of significant medical illnesses that might interfere with prolonged follow up evaluation

ALT > 35 (men) or ALT > 25 (women)

Alkaline Phosphatase >= 150

Any chronic medical condition, including (but not limited to) heart, kidney, or lung diseases

Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Study Objectives

Primary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Recruiting

National Institutes of Health Clinical Center

Bethesda, United StatesOpen National Institutes of Health Clinical Center in Google Maps
Recruiting
One Study Center