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

      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.

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

Start Date

May 27, 1992

Eligibility Criteria

- INCLUSION CRITERIA:

Affected Subjects

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

1. >=2 years of age.

2. 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

Healthy Volunteers

In order to be eligible to participate in this study, a healthy volunteer must meet all of
the following criteria:

1. >= 18 years of age.

2. In good general health as evidenced by medical history

EXCLUSION CRITERIA:

Affected Participants

An affected participant who meets any of the following criteria will be excluded from
participation in this study:

1. History of significant medical illnesses that might interfere with prolonged follow up
evaluation

Healthy Volunteers

A healthy volunteer who meets any of the following criteria will be excluded from
participation in this study:

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

2. Taking any regular medications or supplements (with the exception of regular
multivitamins and/or oral contraceptives)

3. Average alcohol consumption > 1 drink/day in past 6 months, per self-report

4. History of liver disease (with the exception of neonatal jaundice)

5. History of severe illness, infection or major surgery in the past year

6. History of cancer (with the exception of basal cell carcinoma resected > 1 year prior
to enrollment)

7. BMI < 18 or BMI >25

8. Hemoglobin < 11 (women) or hemoglobin < 12 (men)

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

10. Alkaline Phosphatase >= 150

11. Bilirubin >2 g/dL

12. HIV positive, Anti-HCV positive, HBsAg positive or Anti-HBc positive

13. Pregnancy

14. Inability to provide informed consent

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

Administrative Informations

NCT ID

NCT00001971

Organization ID

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

March 24, 2023