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Collections of Blood and Stool Samples in Patients With Acute Hepatitis

This study has been completed.

Sponsored by: National Heart, Lung, and Blood Institute (NHLBI)
Information provided by: National Institutes of Health Clinical Center (CC)
ClinicalTrials.gov Identifier: NCT00001879
  Purpose

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.


Condition
Hepatitis

MedlinePlus related topics:   Hepatitis   

U.S. FDA Resources

Study Type:   Observational
Official Title:   Collection of Blood and Stool Samples in Patients With Acute Hepatitis

Further study details as provided by National Institutes of Health Clinical Center (CC):

Estimated Enrollment:   200
Study Start Date:   March 1999
Estimated Study Completion Date:   March 2001

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.

  Eligibility
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00001879

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

Sponsors and Collaborators
  More Information


Publications:

Study ID Numbers:   990060, 99-H-0060
First Received:   November 3, 1999
Last Updated:   March 3, 2008
ClinicalTrials.gov Identifier:   NCT00001879
Health Authority:   United States: Federal Government

Keywords provided by National Institutes of Health Clinical Center (CC):
Liver Disease  
Novel Agents  
Serum  
Viruses
non-A,G Hepatitis
Seronegative Acute Hepatitis

Study placed in the following topic categories:
Virus Diseases
Hepatitis
Liver Diseases
Digestive System Diseases

ClinicalTrials.gov processed this record on October 31, 2008




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