HepatitisNCT00001879
Collections of Blood and Stool Samples in Patients With Acute Hepatitis
An observational study of Hepatitis, run by National Heart, Lung, and Blood Institute (NHLBI) at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Hepatitis
- How many people
- 200 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 1999to Mar 2001
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Collection of blood samples.
Trial locations and contacts
1 site in 1 country.
United States1 site
National Heart, Lung and Blood Institute (NHLBI)
Bethesda, Maryland, 20892
About this study
Official title: Collection of Blood and Stool Samples in Patients With Acute Hepatitis
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.
Read the 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
- Hepatitis
- Keywords
- Liver Disease, Novel Agents, Serum, Viruses, non-A,G Hepatitis, Seronegative Acute Hepatitis
- Medical subject headings
- Hepatitis, Liver Diseases, Virus Diseases
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2002 (estimated)
- Study startMar 1999
- Study completionMar 2001
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for HepatitisStudies of the same condition, open and under way.
- More trials run by National Heart, Lung, and Blood Institute (NHLBI)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Enrolment
- 200 participants
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00001879
- Sponsor's protocol ID
- 990060
- Other IDs
- 99-H-0060
- Status last verified
- Feb 2000
- First submitted
- 3 Nov 1999
- Last updated
- 22 Mar 2024
- Results posted
- No
Publications
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.
PubMed 7598455Williams 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.
PubMed 9027947
Study at a glance
From the registry record, last updated by the sponsor on 22 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Collection of Blood and Stool Samples in Patients With Acute Hepatitis
- ClinicalTrials.gov ID
- NCT00001879
- Acronym / sponsor ID
- 990060
- Conditions
- Hepatitis
- Keywords
- Liver Disease, Novel Agents, Serum, Viruses, non-A,G Hepatitis, Seronegative Acute Hepatitis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 200 participants
- Lead sponsor
- National Heart, Lung, and Blood Institute (NHLBI)US National Institutes of Health
- Study start
- Mar 1999
- Study completion
- Mar 2001
- First posted
- 10 Dec 2002 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Mar 2024.
- Background: PubMed 7598455Atillasoy 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.
- Background: PubMed 9027947Williams 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.
Related trials for Hepatitis
RecruitingObservational study
Effectiveness and Clinical Outcomes of Long-term Bulevirtide Monotherapy in Patients With HDV-related Compensated Cirrhosis
Hepatitis D
Active, not recruitingPhase 2
A Study of Sequential Therapy With Daplusiran/Tomligisiran (DAP/TOM) Followed by Bepirovirsen in Participants Living With Chronic Hepatitis B (CHB)
Chronic Hepatitis B Virus Infection, Hepatitis B
RecruitingObservational study
Evaluation of Patients With Liver Disease
Hepatitis D, Hepatitis C
Active, not recruitingPhase 2
Study of Bepirovirsen in Participants Living With Human Immunodeficiency Virus and Chronic Hepatitis B Virus Infection (B-Focus)
Hepatitis B
Not yet recruitingObservational study
Elimination of Hepatitis C Virus Among Users of Substances
Hepatitis C in Substance Users
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hepatitis, run by National Heart, Lung, and Blood Institute (NHLBI) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00001879, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Mar 2024.