## Protocol Section
### Identification Module
**NCT ID:** NCT00001879

**Brief Title:** Collections of Blood and Stool Samples in Patients With Acute Hepatitis

**Official Title:** Collection of Blood and Stool Samples in Patients With Acute Hepatitis

#### Organization Study ID Info
**ID:** 990060
#### Organization
**Class:** NIH
**Full Name:** National Institutes of Health Clinical Center (CC)
#### Secondary ID Infos
**ID:** 99-H-0060
### Status Module
#### Completion Date
**Date:** 2001-03

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-03-22

**Type:** ACTUAL

**Last Update Submit Date:** 2024-03-21

**Overall Status:** COMPLETED

#### Start Date
**Date:** 1999-03

**Status Verified Date:** 2000-02

#### Study First Post Date
**Date:** 2002-12-10
**Type:** ESTIMATED
**Study First Submit Date:** 1999-11-03
**Study First Submit QC Date:** 2002-12-09
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** NIH

**Name:** National Heart, Lung, and Blood Institute (NHLBI)

### Description Module

**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.

**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.

### Conditions Module

**Conditions:**

- Hepatitis

**Keywords:**

- Liver Disease

- Novel Agents

- Serum

- Viruses

- non-A,G Hepatitis

- Seronegative Acute Hepatitis

### Design Module

#### Enrollment Info

**Count:** 200

**Study Type:** OBSERVATIONAL

### Eligibility Module

**Eligibility Criteria:** Collection of blood samples.

**Sex:** ALL

**Standard Ages:**

- CHILD

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Bethesda

**Country:** United States

**Facility:** National Heart, Lung and Blood Institute (NHLBI)

**State:** Maryland

**Zip:** 20892

### References Module

#### References

**Citation:** 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:** 7598455

**Citation:** 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:** 9027947

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000008107

- Term: Liver Diseases

- ID: D000004066

- Term: Digestive System Diseases

- ID: D000006525

- Term: Hepatitis, Viral, Human

- ID: D000014777

- Term: Virus Diseases

- ID: D000007239

- Term: Infections

- ID: D000004769

- Term: Enterovirus Infections

- ID: D000010850

- Term: Picornaviridae Infections

- ID: D000012327

- Term: RNA Virus Infections

### Condition Browse Module - Browse Branches

- Abbrev: BC01

- Name: Infections

- Abbrev: BC06

- Name: Digestive System Diseases

- Abbrev: All

- Name: All Conditions

- Abbrev: BC23

- Name: Symptoms and General Pathology

- Abbrev: Rare

- Name: Rare Diseases

### Condition Browse Module - Browse Leaves

- ID: M9592

- Name: Hepatitis A

- Relevance: HIGH

- As Found: Hepatitis

- ID: M9591

- Name: Hepatitis

- Relevance: HIGH

- As Found: Hepatitis

- ID: M11107

- Name: Liver Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M17522

- Name: Virus Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M7255

- Name: Digestive System Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M8883

- Name: Gastrointestinal Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M9610

- Name: Hepatitis, Viral, Human

- Relevance: LOW

- As Found: Unknown

- ID: M10283

- Name: Infections

- Relevance: LOW

- As Found: Unknown

- ID: M6368

- Name: Communicable Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M7930

- Name: Enterovirus Infections

- Relevance: LOW

- As Found: Unknown

- ID: M13745

- Name: Picornaviridae Infections

- Relevance: LOW

- As Found: Unknown

- ID: M15149

- Name: RNA Virus Infections

- Relevance: LOW

- As Found: Unknown

- ID: T170

- Name: Acute Graft Versus Host Disease

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000006506

- Term: Hepatitis A

- ID: D000006505

- Term: Hepatitis

### Intervention Browse Module - Browse Branches

- Abbrev: Hemat

- Name: Hematinics

- Abbrev: All

- Name: All Drugs and Chemicals

### Intervention Browse Module - Browse Leaves

- ID: M11110

- Name: Liver Extracts

- Relevance: LOW

- As Found: Unknown

### Misc Info Module

- Version Holder: 2024-05-24
