Evaluation of Patients With Liver Disease

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Brief Title

Evaluation of Patients With Liver Disease

Official Title

Evaluation of Patients With Liver Disease

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.
    

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 blood and
      urine tests and abdominal ultrasound. Patients will then be followed in the outpatient
      department at intervals appropriate for their clinical status, at which times they will
      undergo an interim medical history and brief examination and have blood studies taken. Liver
      biopsies will be done as a part of this protocol only if clinically indicated. In addition,
      patients may be asked to undergo skin biopsy, plasmapheresis, lymphapheresis, genetic
      analysis, and Fibroscan procedures for research purposes only (immunologic, virologic,
      genetic, and other studies) and separate consent forms are provided. Patients qualifying for
      therapeutic or other trials of antiviral or immunomodulatory agents for their liver disease
      will be invited to enter such studies.
    


Study Type

Observational


Primary Outcome

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


Condition

Hepatitis D


Study Arms / Comparison Groups

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

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information



Estimated Enrollment

8000

Start Date

May 27, 1992



Eligibility Criteria

        -  INCLUSION CRITERIA:

        An indefinite number of patients with acute or chronic liver disease will be enrolled in
        this study. Criteria for selection will be the following:

        Age above 2 years, male or female.

        Evidence of acute or chronic liver disease on evaluation by the outside referring
        physician.

        Absence of other significant medical illnesses that might interfere with prolonged follow
        up evaluation.

        Willingness to enter the study.

        EXCLUSION CRITERIA:

        There are no specific reasons to exclude any patients from this protocol (exception below
        for plasmapheresis and lymphapheresis, and genetic analysis of serum samples) as it does
        not entail significant 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.

        Plasmapheresis and lymphapheresis:Adult patients will have to fulfill the criteria of the
        NIH Department of Transfusion Medicine regarding lymphopheresis 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.
        The only strict

        exclusion criteria for plasmapheresis and lymphapheresis will be patient age (<18 years
        old).

        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.
      

Gender

All

Ages

2 Years - N/A

Accepts Healthy Volunteers

Accepts Healthy Volunteers

Contacts

T. Jake Liang, M.D., (301) 451-6983, [email protected]

Location Countries

United States

Location Countries

United States

Administrative Informations


NCT ID

NCT00001971

Organization ID

910214

Secondary IDs

91-DK-0214

Responsible Party

Sponsor

Study Sponsor

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


Study Sponsor

T. Jake Liang, M.D., Principal Investigator, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)


Verification Date

November 10, 2020