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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

Yes

Population Exclusion(s)

None

Special Instructions

Currently Not Provided

Keywords

Hepatitis B;
Hepatitis C;
Hepatitis D;
Chronic Hepatitis

Recruitment Keyword(s)

Liver Disease

Condition(s)

Hepatitis D;
Hepatitis C;
Hepatitis B;
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:

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.


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Citations:

Not Provided

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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

Patricia E. Alcivar
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
BG 10-CRC RM 4-5722
10 CENTER DR
BETHESDA MD 20814
(301) 435-6121
patricia.alcivar@nih.gov

Office of Patient Recruitment
National Institutes of Health Clinical Center (CC)
Building 61, 10 Cloister Court
Bethesda, Maryland 20892
Toll Free: 1-800-411-1222
Local Phone: 301-451-4383
TTY: 1-866-411-1010
PRPL@cc.nih.gov

Clinical Trials Number:

NCT00001971

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