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Protocol Details

Evaluation of Patients with Liver Disease

This study is currently recruiting participants.

Summary | Eligibility | Citations | Contacts

Summary

Number

91-dk-0214

Sponsoring Institute

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

Recruitment Detail

Type: Participants currently recruited/enrolled
Gender: Male & Female
Min Age: 2
Max Age: N/A

Referral Letter Required

No

Population Exclusion(s)

None

Special Instructions

Currently Not Provided

Keywords

Hepatitis B;
Hepatitis C;
Hepatitis D;
Chronic Cholestatic Syndromes;
Primary Biliary Cirrhosis;
Primary Sclerosing Cholangitis;
Non-Alcoholic Steatohepatitis;
Wilson's Disease;
Hemochromatosis;
Liver Biopsy;
Noncirrhotic Portal Hypertension

Recruitment Keyword(s)

Liver Disease;
Hepatitis C

Condition(s)

Biliary Liver Cirrhosis,;
Hemochromatosis;
Hepatitis;
Hepatolenticular Degeneration;
Liver Disease

Investigational Drug(s)

None

Investigational Device(s)

None

Intervention(s)

None

Supporting Site

National Institute of Diabetes and Digestive and Kidney Diseases

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.

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Eligibility

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: Patients will have to fulfill the criteria of the NIH Department of Transfusion Medicine regarding lymphapheresis donors. These include age (less that 65 years), weight (greater than 120 pounds), hematocrit (greater than 30 percent), blood pressure (less than 120 diastolic and greater than 90 systolic), and temperature (less than 37.5 degrees C). 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) will be asked to undergo this procedure.

The only strict exclusion criterion will be active therapy with interferon. The basis for this exclusion was the findings from a retrospective analysis of a recent trial of recombinant human alpha interferon as therapy of chronic hepatitis B. In that study, the "response rate" or rate of clearance of hepatitis B virus with alpha interferon therapy was lower among patients who underwent lymphapheresis during therapy (48 percent) (p less than .01). Lymphapheresis performed before treatment did not seem to affect the outcome of interferon therapy. These findings were unexpected but have led us to avoid both plasmapheresis and lymphapheresis in patients receiving alpha interferon therapy. The reasons why lymphapheresis might interfere with a response to alpha interferon are to known, but probably relate to the importance of an intact, healthy immune system in the process of recovery from a chronic viral infection.

Fibroscan: Consecutive adult patients (ages 18 or older) with chronic liver disease who have had a liver biopsy performed within the previous 6 months or who are scheduled to undergo liver biopsy will be eligible for participation in this aspect of the study. Patients with liver biopsies that are inadequate for histological scoring or who have ascites will be excluded from this aspect of the study.

Genetic Analysis of Serum Samples: All adult subjects with a Hct of less than 30 and pediatric subjects with a Hct less than 26 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.


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Citations:

Chronic hepatitis B and the healthy carrier state

Seroconversion from hepatitis B e antigen to antibody in chronic type B hepatitis

Serologic diagnosis of acute and chronic viral hepatitis

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Contacts:

Principal Investigator

Referral Contact

For more information:

T. Jake Liang, M.D.
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
BG 10 RM 9B16
10 CENTER DR
BETHESDA MD 20814
(301) 496-1721
jakel@mail.nih.gov

Nancy Fryzek
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
National Institutes of Health
Building 10
Room 4-5722
10 Center Drive
Bethesda, Maryland 20892
(301) 435-6122
nancy.fryzek@nih.gov

Patient Recruitment and Public Liaison Office
Building 61
10 Cloister Court
Bethesda, Maryland 20892-4754
Toll Free: 1-800-411-1222
TTY: 301-594-9774 (local),1-866-411-1010 (toll free)
Fax: 301-480-9793

prpl@mail.cc.nih.gov

Clinical Trials Number:

NCT00001971

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