Viewing Study NCT00005936



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Last Modification Date: 2024-10-26 @ 9:05 AM
Study NCT ID: NCT00005936
Status: COMPLETED
Last Update Posted: 2008-03-04
First Post: 2000-07-06

Brief Title: Collection of Liver Tissue for Virologic Studies
Sponsor: National Heart Lung and Blood Institute NHLBI
Organization: National Institutes of Health Clinical Center CC

Study Overview

Official Title: Collection of Liver Tissue for Virologic Studies
Status: COMPLETED
Status Verified Date: 2002-03
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
Brief Summary: 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
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 Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: None
Is a FDA Regulated Device?: None
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None
Secondary IDs
Secondary ID Type Domain Link
00-H-0167 None None None