Completed

Collection of Blood and Stool Samples in Patients With Acute Hepatitis

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What is being collected

Data Collection

Who is being recruted

Digestive System Diseases+2

+ Infections

+ Hepatitis

See all eligibility criteria
How is the trial designed

Observational
Study Start: March 1999
See protocol details

Summary

Principal SponsorNational Heart, Lung, and Blood Institute (NHLBI)
Last updated: March 22, 2024
Sourced from a government-validated database.Claim as a partner

Study start date: March 1, 1999

Actual date on which the first participant was enrolled.

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.

NCT00001879
Principal SponsorNational Heart, Lung, and Blood Institute (NHLBI)
Last updated: March 22, 2024
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

200 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Digestive System DiseasesInfectionsHepatitisLiver DiseasesVirus Diseases

Criteria

Collection of blood samples.

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

National Heart, Lung and Blood Institute (NHLBI)

Bethesda, United StatesOpen National Heart, Lung and Blood Institute (NHLBI) in Google Maps
CompletedOne Study Center