Kidney-transplant Recipients With Chronic Hepatitis E Virus InfectionNCT01090232
Host Responses in Kidney-transplant Recipients With Chronic Hepatitis E Virus Infection
A study testing blood samples in people with Kidney-transplant Recipients With Chronic Hepatitis E Virus Infection, run by Assistance Publique Hopitaux De Marseille at 1 site in France.
Trial summary
Hepatitis E is a worldwide disease. It is the leading or second leading cause of acute hepatitis in adults in developing countries from sub-Saharan Africa or Southeast Asia, where it is hyperendemic and principally water-borne. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Kidney-transplant Recipients With Chronic Hepatitis E Virus Infection
- What is being tested?
- blood samples
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 17 participants
- Where
- 1 siteFrance
- Study dates
- Feb 2010to Aug 2012
- Phase
- Interventional
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age > 18 years
- Transplanted by a functional kidney
- affected by a hepatitis E chronic
- Benefiting from a follow-up in the Center of Nephrology and renal Transplantation or in the service of Hépato-gastro-entérologie of the CHU The Conception in Marseille
- Having signed a consent informed about participation in the study
Who cannot join
- Affected by another sharp or chronic viral infection
Trial locations and contacts
1 site in 1 country.
About this study
Hepatitis E is a worldwide disease. It is the leading or second leading cause of acute hepatitis in adults in developing countries from sub-Saharan Africa or Southeast Asia, where it is hyperendemic and principally water-borne. In industrialised western countries, hepatitis E was until recently considered as imported from hyperendemic geographical areas, but is currently an emerging autochthonous infectious disease. A growing body of data from Europe, America, Australia, and Asia strongly indicate that pigs represent a major Hepatitis E Virus (HEV) reservoir and might be a source of zoonotic transmission to humans through direct or indirect exposure. Hepatitis E typically causes self-limited acute infection. However, the overall death rate is 1-4%, and it can reach 20% in pregnant women and might be still higher in patients with underlying chronic liver disease. To date, no preventive or curative treatment of hepatitis E is available.
Read the detailed description
Therefore, the major goal of the study is to analyse for the first time the host responses in kidney-transplant recipients with chronic HEV infection and to compare them to the host responses in kidney-transplant recipients without viral infection (controls), to identify a specific peripheral signature using blood microarray-based gene expression profiling.
Other minor goals are :
- to assess the incidence of HEV infection in kidney-transplant recipients from south-eastern France, to study the risk factors, and to describe the clinical features and outcomes of chronic HEV infection in kidney-transplant recipients,
- to compare the peripheral signature to a liver signature in the cases where a liver biopsy is available. If peripheral and liver signatures are parallel, peripheral signature may become a non-invasive tool of exploration of chronic HEV infection in kidney-transplant recipients.
- Being tested
- blood samples
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
blood samplesOther
blood samplesOther
| Study group | Role | What they receive |
|---|---|---|
| chronic HEV infection | Experimental | in kidney-transplant recipients with chronic HEV infection Receives: Other: blood samples |
| control | Active comparator | the host responses in kidney-transplant recipients without viral infection (controls) Receives: Other: blood samples |
What is being measured
The primary outcome is the main question the study is designed to answer.
analysethe the host responses in kidney-transplant recipients with chronic HEV infection
to analyse for the first time the host responses in kidney-transplant recipients with chronic HEV infection and to compare them to the host responses in kidney-transplant recipients without viral infection (controls), to identify a specific peripheral signature using blood microarray-based gene expression profiling.
Measured: 2 years
Secondary outcomes (1)
the incidence of HEV infection in kidney-transplant
to assess the incidence of HEV infection in kidney-transplant recipients from south-eastern France, to study the risk factors, and to describe the clinical features and outcomes of chronic HEV infection in kidney-transplant recipients,
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2010 (estimated)
- Study startFeb 2010
- Primary completionFeb 2012
- Study completionAug 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Kidney-transplant Recipients With Chronic Hepatitis E Virus InfectionStudies of the same condition, open and under way.
- More trials run by Assistance Publique Hopitaux De MarseilleThe 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
- Interventional
- Phase
- Phase N/A
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique Hopitaux De Marseille
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- VALERIE MOAL, Principal investigator, Assistance Publique Hopitaux De Marseille
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01090232
- Sponsor's protocol ID
- 2009-A00945-52
- Other IDs
- 2009 20
- Status last verified
- Aug 2014
- First submitted
- 18 Mar 2010
- Last updated
- 1 Sep 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Moal V, Textoris J, Ben Amara A, Mehraj V, Berland Y, Colson P, Mege JL. Chronic hepatitis E virus infection is specifically associated with an interferon-related transcriptional program. J Infect Dis. 2013 Jan 1;207(1):125-32. doi: 10.1093/infdis/jis632. Epub 2012 Oct 16.
PubMed 23072754
Study at a glance
From the registry record, last updated by the sponsor on 1 Sep 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Host Responses in Kidney-transplant Recipients With Chronic Hepatitis E Virus Infection
- ClinicalTrials.gov ID
- NCT01090232
- Acronym / sponsor ID
- 2009-A00945-52
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- Assistance Publique Hopitaux De MarseilleUniversity, hospital or other
- Study start
- Feb 2010
- Primary completion
- Feb 2012 (actual)
- Study completion
- Aug 2012 (actual)
- First posted
- 19 Mar 2010 (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 E is a worldwide disease. It is the leading or second leading cause of acute hepatitis in adults in developing countries from sub-Saharan Africa or Southeast Asia, where it is hyperendemic and principally water-borne. In industrialised western countries, hepatitis E was until recently considered as imported from hyperendemic geographical areas, but is currently an emerging autochthonous infectious disease. A growing body of data from Europe, America, Australia, and Asia strongly indicate that pigs represent a major Hepatitis E Virus (HEV) reservoir and might be a source of zoonotic transmission to humans through direct or indirect exposure. Hepatitis E typically causes self-limited acute infection. However, the overall death rate is 1-4%, and it can reach 20% in pregnant women and might be still higher in patients with underlying chronic liver disease. To date, no preventive or curative treatment of hepatitis E is available.
Detailed description
Therefore, the major goal of the study is to analyse for the first time the host responses in kidney-transplant recipients with chronic HEV infection and to compare them to the host responses in kidney-transplant recipients without viral infection (controls), to identify a specific peripheral signature using blood microarray-based gene expression profiling.
Other minor goals are :
- to assess the incidence of HEV infection in kidney-transplant recipients from south-eastern France, to study the risk factors, and to describe the clinical features and outcomes of chronic HEV infection in kidney-transplant recipients,
- to compare the peripheral signature to a liver signature in the cases where a liver biopsy is available. If peripheral and liver signatures are parallel, peripheral signature may become a non-invasive tool of exploration of chronic HEV infection in kidney-transplant recipients.
Study design
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| chronic HEV infection | Experimental | Other: blood samplesin kidney-transplant recipients with chronic HEV infection |
| control | Active comparator | Other: blood samplesthe host responses in kidney-transplant recipients without viral infection (controls) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age > 18 years
- Transplanted by a functional kidney
- affected by a hepatitis E chronic
- Benefiting from a follow-up in the Center of Nephrology and renal Transplantation or in the service of Hépato-gastro-entérologie of the CHU The Conception in Marseille
- Having signed a consent informed about participation in the study
Key exclusion criteria (1 listed)
- Affected by another sharp or chronic viral infection
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| blood samples | Other | chronic HEV infection |
| blood samples | Other | control |
Primary outcome
analysethe the host responses in kidney-transplant recipients with chronic HEV infection
Time frame: 2 years
to analyse for the first time the host responses in kidney-transplant recipients with chronic HEV infection and to compare them to the host responses in kidney-transplant recipients without viral infection (controls), to identify a specific peripheral signature using blood microarray-based gene expression profiling.
1 secondary outcome
the incidence of HEV infection in kidney-transplant
Time frame: 2 years
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 1 Sep 2014.
- Derived from this study: PubMed 23072754Moal V, Textoris J, Ben Amara A, Mehraj V, Berland Y, Colson P, Mege JL. Chronic hepatitis E virus infection is specifically associated with an interferon-related transcriptional program. J Infect Dis. 2013 Jan 1;207(1):125-32. doi: 10.1093/infdis/jis632. Epub 2012 Oct 16.
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.
VALERIE MOAL principal investigator
Assistance Publique Hopitaux De Marseille
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing blood samples in people with Kidney-transplant Recipients With Chronic Hepatitis E Virus Infection, run by Assistance Publique Hopitaux De Marseille at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Sep 2014. 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 France. 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.
What does the primary outcome measure?
analysethe the host responses in kidney-transplant recipients with chronic HEV infection (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01090232, which also lists 1 linked publication.
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 1 Sep 2014; AzTrials last refreshed its copy on 6 Nov 2026.