Collection of Liver Tissue for Virologic Studies

March 3, 2008 updated by: National Heart, Lung, and Blood Institute (NHLBI)

This study will examine liver tissue to investigate the role of viral infections in fulminant hepatitis, liver failure, and profound bone marrow failure.

All patients who are undergoing liver biopsy or liver transplantation may participate in this study. For patients undergoing liver biopsy, a small piece of liver tissue will be taken from the sample collected during the scheduled biopsy. For patients undergoing liver transplantation, a small piece of tissue will be collected from the diseased liver that is to be removed.

Study Overview

Status

Completed

Conditions

Detailed Description

Our laboratory has a long-standing interest in viruses that affect the bone marrow. Many such viruses also may cause hepatitis. One specific syndrome, post-hepatitis aplastic anemia, suggests that the same agent is responsible for both severe and sometimes fulminant hepatitis as well as profound bone marrow failure. In investigating the role of viruses in these diseases, we require small amounts of liver tissue for molecular studies. We request permission to obtain samples from patients undergoing 1) liver transplantation or 2) liver biopsy at the time of surgery for purpose of virus discovery, including obtaining control samples. For liver transplant samples, tissue will be obtained from the removed organ; in other surgical circumstances, small amounts of tissue will be obtained when the liver is biopsied for other medical indications. No additional risk to the patient should result from either procedure.

Study Type

Observational

Enrollment

50

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Maryland
      • Bethesda, Maryland, United States, 20892
        • National Heart, Lung and Blood Institute (NHLBI)

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

All patients undergoing open liver biopsy or the removal of liver for purposes of hepatic transplantation are eligible for participation.

There are no exclusion criteria.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Heart, Lung, and Blood Institute (NHLBI)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2000

Study Completion

March 1, 2002

Study Registration Dates

First Submitted

July 6, 2000

First Submitted That Met QC Criteria

July 6, 2000

First Posted (Estimate)

July 7, 2000

Study Record Updates

Last Update Posted (Estimate)

March 4, 2008

Last Update Submitted That Met QC Criteria

March 3, 2008

Last Verified

March 1, 2002

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 000167
  • 00-H-0167

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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