Viewing Study NCT00001879



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Last Modification Date: 2024-10-26 @ 9:02 AM
Study NCT ID: NCT00001879
Status: COMPLETED
Last Update Posted: 2024-03-22
First Post: 1999-11-03

Brief Title: Collections of Blood and Stool Samples in Patients With Acute Hepatitis
Sponsor: National Heart Lung and Blood Institute NHLBI
Organization: National Institutes of Health Clinical Center CC

Study Overview

Official Title: Collection of Blood and Stool Samples in Patients With Acute Hepatitis
Status: COMPLETED
Status Verified Date: 2000-02
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: 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 heshe 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
Detailed Description: While several viruses have been identified as agents of liver inflammation some proportion of cases of acute hepatitis are seronegative and show no evidence of prior infection with known hepatitis viruses A B C or E Seronegative acute hepatitis is often complicated by autoimmune phenomena or late severe consequences especially fulminant hepatitis of childhood and post-hepatitis aplastic anemia Efforts in the Hematology Branch to identify an infectious agent in these latter two syndromes have been unsuccessful probably because they are immune-mediated and also accompanied by massive tissue destruction We now propose systematic collection of blood and fecal samples from patients with seronegative acute hepatitis for purposes of virus identification research Samples will be collected from patients in United States Army clinics patient identifiers will be employed

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
99-H-0060 None None None