Evaluation of Patients With Liver Disease

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 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 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.

Estimated Enrollment

8000

Start Date

May 27, 1992

Eligibility Criteria

        -  INCLUSION CRITERIA:

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

          1. Stated willingness to comply with all study procedures and availability for the
             duration of the study

          2. Male or female, >=2 years of age.

          3. Suspected or evidence of acute or chronic liver disease on evaluation by a referring
             licensed independent practitioner (LIP), healthcare organization or study subject.

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

          5. 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.
      

Gender

All

Ages

2 Years - N/A

Accepts Healthy Volunteers

Accepts Healthy Volunteers

Contacts

T. Jake Liang, M.D., (301) 435-6121, [email protected]

Location Countries

United States

Location Countries

United States

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

October 18, 2021