Evaluation of Patients With Liver Disease

  • STATUS
    Recruiting
  • participants needed
    8000
  • sponsor
    National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Updated on 22 September 2022
liver disease
Accepts healthy volunteers

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....

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.

Details
Condition Hepatitis D, Hepatitis C, Hepatitis B, Liver Disease
Clinical Study IdentifierNCT00001971
SponsorNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Last Modified on22 September 2022

Eligibility

Yes No Not Sure

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
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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