NCT00001879

Brief Summary

Hepatitis is an inflammation of the liver. Hepatitis can be caused by an infection with a virus, but poisonous (toxic) substances can also cause it. Researchers have identified several of the viruses responsible for hepatitis, however some patients with hepatitis show no evidence of being infected with known hepatitis viruses. Researchers call conditions like this, seronegative hepatitis. It means that a patient has hepatitis but he/she does not have evidence in their blood of a viral infection. Seronegative hepatitis is often complicated by autoimmune disorders and associated severe disorders especially, fulminant hepatitis of childhood and post-hepatitis aplastic anemia. Researchers have attempted to identify the cause of these conditions but have been unsuccessful. Therefore, this study was developed to collect blood and stool samples from patients with seronegative hepatitis in order to help identify the virus responsible.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 1999

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

March 1, 1999

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

November 3, 1999

Completed
1.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2001

Completed
1.8 years until next milestone

First Posted

Study publicly available on registry

December 10, 2002

Completed
Last Updated

March 22, 2024

Status Verified

February 1, 2000

First QC Date

November 3, 1999

Last Update Submit

March 21, 2024

Conditions

Hepatitis

Keywords

Liver DiseaseNovel AgentsSerumVirusesnon-A,G HepatitisSeronegative Acute Hepatitis

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Collection of blood samples.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

National Heart, Lung and Blood Institute (NHLBI)

Bethesda, Maryland, 20892, United States

Location

Related Publications (2)

  • Atillasoy E, Berk PD. Fulminant hepatic failure: pathophysiology, treatment, and survival. Annu Rev Med. 1995;46:181-91. doi: 10.1146/annurev.med.46.1.181.

    PMID: 7598455BACKGROUND

  • Williams R. Classification, etiology, and considerations of outcome in acute liver failure. Semin Liver Dis. 1996 Nov;16(4):343-8. doi: 10.1055/s-2007-1007247.

    PMID: 9027947BACKGROUND

MeSH Terms

Conditions

HepatitisLiver DiseasesVirus Diseases

Condition Hierarchy (Ancestors)

Digestive System DiseasesInfections

Study Design

Study Type
observational
Sponsor Type
NIH

Study Record Dates

First Submitted

November 3, 1999

First Posted

December 10, 2002

Study Start

March 1, 1999

Study Completion

March 1, 2001

Last Updated

March 22, 2024

Record last verified: 2000-02

Locations

US(1)