Evaluation of Patients With Liver Disease

Sponsor

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

Overall Status

Recruiting

CT.gov ID

NCT00001971

Collaborator

(none)

8,000

Enrollment

Location

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Hepatitis D Hepatitis C Hepatitis B Liver Disease

Detailed Description

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. Patients will initially be seen in the outpatient department and undergo a medical history and physical examination. They will have a series of of clinical evaluation and the collection of research samples. Patients will then be followed in the outpatient department at intervals appropriate for their clinical status. At which patients will undergo an interim medical history and brief examination, with research samples collected. Collection of additional tissue biopsy may be obtained during a clinically indicated procedure such as liver biopsy.

Subjects may be asked to undergo leukapheresis or plasmapheresis, and genetic analysis for research purposes, and separate consent forms are provided. In addition, a control group of healthy volunteers will be recruited for genetic analysis, leukapheresis and plasmapheresis.

Subjects who qualify for other studies of their liver disease will be offered participation.

Study Design

Study Type:

Observational

Anticipated Enrollment :

8000 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

Evaluation of Patients With Liver Disease

Actual Study Start Date :

May 27, 1992

Arms and Interventions

Arm	Intervention/Treatment
Healthy individuals Healthy individuals who have recovered from liver diseases or who are healthy volunteers
Patients Liver disease patients

Outcome Measures

Primary Outcome Measures

Predisposition and outcomes related to liver disease susceptibility, progression, and treatment response [Annual visits]
Predisposition and outcomes related to liver disease susceptibility, progression, and treatment response

Eligibility Criteria

Criteria

Ages Eligible for Study:

2 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

INCLUSION CRITERIA:

In order to be eligible to participate in this study, an individual must meet all of the following criteria:

Stated willingness to comply with all study procedures and availability for the duration of the study
Male or female, >=2 years of age.
Suspected or evidence of acute or chronic liver disease on evaluation by a referring licensed independent practitioner (LIP), healthcare organization or study subject.
Absence of other significant medical illnesses that might interfere with prolonged follow up evaluation.
Ability of subject, parent/guardian or Legally Authorized Representative to understand and the willingness to sign a written informed consent document.

EXCLUSION CRITERIA:

There are no specific reasons to exclude any patients from this protocol as it does not entail sig- nificant risk to the patient or excessive clinical burden to the Liver Diseases Branch. Patients who resolve their chronic liver disease, such as patients with chronic hepatitis B who become negative for HBsAg or patients with chronic hepatitis C who become negative for HCV RNA will continue to be followed despite lack of apparent disease or disability. This is to document that clearance of these hepatitis viruses is, indeed, associated with resolution of the liver disease and lack of long-term adverse effects. Because there are data suggesting that chronic HBsAg carriers who become HBsAg-negative and patients with chronic hepatitis C whose liver disease becomes inactive can still develop long-term consequences of these diseases (especially hepatocellular carcinoma), following such patients is important.

Adults only may have the following research tests but must meet certain criteria to have these research procedures:

Genetic Analysis of Serum Samples:

Adult subjects with clinically significant anemia will be excluded for phlebotomy that is necessary for isolation of DNA material from the blood cells.
Inability to understand or sign informed consent will also exclude patients from this aspect of the study

Apheresis:

Adult subjects will have to fulfill the criteria of the NIH Department of Transfusion Medicine regarding leukapheresis and plasmapheresis donors.
Because this is a research procedure to obtain reagents and assay materials, only patients who are active and relatively fit (i.e. not disabled from their liver disease) and do not exhibit any contraindications for the procedure will be asked to undergo this procedure.
Subject s <18 years old are excluded from apheresis.
Decisionally impaired adults are excluded from apheresis.
Pregnant women are excluded from apheresis procedures.