NCT00005936

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jun 2000

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2000

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

July 6, 2000

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 7, 2000

Completed
1.6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2002

Completed
Last Updated

March 4, 2008

Status Verified

March 1, 2002

First QC Date

July 6, 2000

Last Update Submit

March 3, 2008

Conditions

Virus Disease

Keywords

Fulminant HepatitisParvovirusHepatitisBiopsyControlLiver Biopsy

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Heart, Lung and Blood Institute (NHLBI)

Bethesda, Maryland, 20892, United States

Location

Related Publications (3)

  • Naides SJ, Karetnyi YV, Cooling LL, Mark RS, Langnas AN. Human parvovirus B19 infection and hepatitis. Lancet. 1996 Jun 1;347(9014):1563-4. doi: 10.1016/s0140-6736(96)90720-5. No abstract available.

    PMID: 8684141BACKGROUND

  • Tzakis AG, Arditi M, Whitington PF, Yanaga K, Esquivel C, Andrews WA, Makowka L, Malatak J, Freese DK, Stock PG, et al. Aplastic anemia complicating orthotopic liver transplantation for non-A, non-B hepatitis. N Engl J Med. 1988 Aug 18;319(7):393-6. doi: 10.1056/NEJM198808183190702.

    PMID: 3135496BACKGROUND

  • Brown KE, Tisdale J, Barrett AJ, Dunbar CE, Young NS. Hepatitis-associated aplastic anemia. N Engl J Med. 1997 Apr 10;336(15):1059-64. doi: 10.1056/NEJM199704103361504.

    PMID: 9091802BACKGROUND

MeSH Terms

Conditions

Virus DiseasesMassive Hepatic NecrosisParvoviridae InfectionsHepatitis

Condition Hierarchy (Ancestors)

InfectionsChemical and Drug Induced Liver InjuryLiver DiseasesDigestive System DiseasesLiver Failure, AcuteLiver FailureHepatic InsufficiencyDNA Virus Infections

Study Design

Study Type
observational
Sponsor Type
NIH

Study Record Dates

First Submitted

July 6, 2000

First Posted

July 7, 2000

Study Start

June 1, 2000

Study Completion

March 1, 2002

Last Updated

March 4, 2008

Record last verified: 2002-03

Locations

US(1)