Clinical Trial Study:Evaluation of Patients with Liver Disease

[Guest guest]

Evaluation of Patients with Liver Disease

This study is currently recruiting patients.

Sponsored by

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

Purpose

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.

Condition

Biliary Liver Cirrhosis,

Hemochromatosis

Hepatitis

Hepatolenticular Degeneration

Liver Disease

Study Type: Observational

Further Study Details:

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 and D, primary biliary cirrhosis, primary sclerosing

cholangitis, 's disease, hemochromatosis, non-alcoholic

steatohepatitis (NASH), 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 with

visits every 1 to 12 months 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, and a separate consent form is provided. In addition, patients

may be asked to undergo skin biopsy, plasmapheresis, and lymphapheresis

procedures for research purposes only (immunlogic, virologic 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 offered the opportunity to enter such studies.

Eligibility

Genders Eligible for Study: Both

Criteria

Patients with acute or chronic liver disease that meet the following

criteria:

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.

Expected Total Enrollment: 999

Location and Contact Information

land

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

9000 Rockville Pike Bethesda, land, 20892, United States;

Recruiting

Patient Recruitment and Public Liaison Office 1-800-411-1222

prpl@...

TTY 1-866-411-1010

More Information

Detailed Web Page

Publications

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

Study ID Numbers 910214; 91-DK-0214

Date study started September 9, 1991

Record last reviewed August 31, 2001

Last Updated August 31, 2001

NLM Identifier NCT00001971

ClinicalTrials.gov processed this record on 2001-12-26

[Guest guest]

Evaluation of Patients with Liver Disease

This study is currently recruiting patients.

Sponsored by

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

Purpose

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.

Condition

Biliary Liver Cirrhosis,

Hemochromatosis

Hepatitis

Hepatolenticular Degeneration

Liver Disease

Study Type: Observational

Further Study Details:

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 and D, primary biliary cirrhosis, primary sclerosing

cholangitis, 's disease, hemochromatosis, non-alcoholic

steatohepatitis (NASH), 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 with

visits every 1 to 12 months 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, and a separate consent form is provided. In addition, patients

may be asked to undergo skin biopsy, plasmapheresis, and lymphapheresis

procedures for research purposes only (immunlogic, virologic 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 offered the opportunity to enter such studies.

Eligibility

Genders Eligible for Study: Both

Criteria

Patients with acute or chronic liver disease that meet the following

criteria:

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.

Expected Total Enrollment: 999

Location and Contact Information

land

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

9000 Rockville Pike Bethesda, land, 20892, United States;

Recruiting

Patient Recruitment and Public Liaison Office 1-800-411-1222

prpl@...

TTY 1-866-411-1010

More Information

Detailed Web Page

Publications

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

Study ID Numbers 910214; 91-DK-0214

Date study started September 9, 1991

Record last reviewed August 31, 2001

Last Updated August 31, 2001

NLM Identifier NCT00001971

ClinicalTrials.gov processed this record on 2001-12-26