Virus DiseaseNCT00005936
Collection of Liver Tissue for Virologic Studies
An observational study of Virus Disease, run by National Heart, Lung, and Blood Institute (NHLBI) at 1 site in United States.
Trial summary
This study will examine liver tissue to investigate the role of viral infections in fulminant hepatitis, liver failure, and profound bone marrow failure. All patients who are undergoing liver biopsy or liver transplantation may participate in this study. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Virus Disease
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2000to Mar 2002
- 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
All patients undergoing open liver biopsy or the removal of liver for purposes of hepatic transplantation are eligible for participation.
There are no exclusion criteria.
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
This study will examine liver tissue to investigate the role of viral infections in fulminant hepatitis, liver failure, and profound bone marrow failure.
All patients who are undergoing liver biopsy or liver transplantation may participate in this study. For patients undergoing liver biopsy, a small piece of liver tissue will be taken from the sample collected during the scheduled biopsy. For patients undergoing liver transplantation, a small piece of tissue will be collected from the diseased liver that is to be removed.
Read the detailed description
Our laboratory has a long-standing interest in viruses that affect the bone marrow. Many such viruses also may cause hepatitis. One specific syndrome, post-hepatitis aplastic anemia, suggests that the same agent is responsible for both severe and sometimes fulminant hepatitis as well as profound bone marrow failure. In investigating the role of viruses in these diseases, we require small amounts of liver tissue for molecular studies. We request permission to obtain samples from patients undergoing 1) liver transplantation or 2) liver biopsy at the time of surgery for purpose of virus discovery, including obtaining control samples. For liver transplant samples, tissue will be obtained from the removed organ; in other surgical circumstances, small amounts of tissue will be obtained when the liver is biopsied for other medical indications. No additional risk to the patient should result from either procedure.
- Conditions
- Virus Disease
- Keywords
- Fulminant Hepatitis, Parvovirus, Hepatitis, Biopsy, Control, Liver Biopsy
- Medical subject headings
- Virus Diseases, Massive Hepatic Necrosis, Parvoviridae Infections, Hepatitis
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2000 (estimated)
- Study startJun 2000
- Study completionMar 2002
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Virus DiseaseStudies 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
- 50 participants
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00005936
- Sponsor's protocol ID
- 000167
- Other IDs
- 00-H-0167
- Status last verified
- Mar 2002
- First submitted
- 6 Jul 2000
- Last updated
- 4 Mar 2008
- Results posted
- No
Publications
Naides SJ, Karetnyi YV, Cooling LL, Mark RS, Langnas AN. Human parvovirus B19 infection and hepatitis. Lancet. 1996 Jun 1;347(9014):1563-4. doi: 10.1016/s0140-6736(96)90720-5. No abstract available.
PubMed 8684141Tzakis AG, Arditi M, Whitington PF, Yanaga K, Esquivel C, Andrews WA, Makowka L, Malatak J, Freese DK, Stock PG, et al. Aplastic anemia complicating orthotopic liver transplantation for non-A, non-B hepatitis. N Engl J Med. 1988 Aug 18;319(7):393-6. doi: 10.1056/NEJM198808183190702.
PubMed 3135496Brown KE, Tisdale J, Barrett AJ, Dunbar CE, Young NS. Hepatitis-associated aplastic anemia. N Engl J Med. 1997 Apr 10;336(15):1059-64. doi: 10.1056/NEJM199704103361504.
PubMed 9091802
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Collection of Liver Tissue for Virologic Studies
- ClinicalTrials.gov ID
- NCT00005936
- Acronym / sponsor ID
- 000167
- Conditions
- Virus Disease
- Keywords
- Fulminant Hepatitis, Parvovirus, Hepatitis, Biopsy, Control, Liver Biopsy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants
- Lead sponsor
- National Heart, Lung, and Blood Institute (NHLBI)US National Institutes of Health
- Study start
- Jun 2000
- Study completion
- Mar 2002
- First posted
- 7 Jul 2000 (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.
This study will examine liver tissue to investigate the role of viral infections in fulminant hepatitis, liver failure, and profound bone marrow failure.
All patients who are undergoing liver biopsy or liver transplantation may participate in this study. For patients undergoing liver biopsy, a small piece of liver tissue will be taken from the sample collected during the scheduled biopsy. For patients undergoing liver transplantation, a small piece of tissue will be collected from the diseased liver that is to be removed.
Detailed description
Our laboratory has a long-standing interest in viruses that affect the bone marrow. Many such viruses also may cause hepatitis. One specific syndrome, post-hepatitis aplastic anemia, suggests that the same agent is responsible for both severe and sometimes fulminant hepatitis as well as profound bone marrow failure. In investigating the role of viruses in these diseases, we require small amounts of liver tissue for molecular studies. We request permission to obtain samples from patients undergoing 1) liver transplantation or 2) liver biopsy at the time of surgery for purpose of virus discovery, including obtaining control samples. For liver transplant samples, tissue will be obtained from the removed organ; in other surgical circumstances, small amounts of tissue will be obtained when the liver is biopsied for other medical indications. No additional risk to the patient should result from either procedure.
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 4 Mar 2008.
- Background: PubMed 8684141Naides SJ, Karetnyi YV, Cooling LL, Mark RS, Langnas AN. Human parvovirus B19 infection and hepatitis. Lancet. 1996 Jun 1;347(9014):1563-4. doi: 10.1016/s0140-6736(96)90720-5. No abstract available.
- Background: PubMed 3135496Tzakis AG, Arditi M, Whitington PF, Yanaga K, Esquivel C, Andrews WA, Makowka L, Malatak J, Freese DK, Stock PG, et al. Aplastic anemia complicating orthotopic liver transplantation for non-A, non-B hepatitis. N Engl J Med. 1988 Aug 18;319(7):393-6. doi: 10.1056/NEJM198808183190702.
- Background: PubMed 9091802Brown KE, Tisdale J, Barrett AJ, Dunbar CE, Young NS. Hepatitis-associated aplastic anemia. N Engl J Med. 1997 Apr 10;336(15):1059-64. doi: 10.1056/NEJM199704103361504.
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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 Virus Disease, 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 4 Mar 2008. 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 NCT00005936, which also lists 3 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 4 Mar 2008.