Cytomegalovirus InfectionVHENUSNCT01473849
Impact of Cytomegalovirus (CMV) Replication Over Hepatitis C Recurrence in Liver Transplant Recipients
An observational study of Cytomegalovirus Infection and Hepatitis C, run by Sociedad Española de Trasplante Hepático at 13 sites in Spain.
Trial summary
The relationship between cytomegalovirus infection and recurrence of hepatitis C in liver transplant recipients remains controversial. Although some studies (Teixeira et al., 2000; Singh et al., 2005)have not found an association between recurrence of hepatitis C and CMV infection, studies such as Rosen et al. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cytomegalovirus Infection, Hepatitis C
- How many people
- 179 participants
- Where
- 13 sitesSpain
- Study dates
- May 2010to Apr 2013
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients who underwent liver transplantation after hepatopathy caused by HCV
Who may be able to join
- Men or women who underwent liver transplantation after hepatopathy caused by HCV, confirmed by pre-transplantation detection of HCV RNA
- Age > 18 years old
Who cannot join
- Patients co-infected with HBV or HIV
- Patients who show other causes of liver disease
Trial locations and contacts
13 sites in 1 country.
13 sites in 1 country
Spain13 sites
Hospital Vall d'Hebron
Barcelona, Barcelona, 08035
Hospital Reina Sofía
Córdoba, Córdoba, 14004
Hospital de Bellvitge
L'Hospitalet de Llobregat, Barcelona, 08907
Hospital General Universitario Gregorio Marañón
Madrid, Madrid, 28009
Hospital Ramón y Cajal
Madrid, Madrid, 28039
Hospital 12 de Octubre
Madrid, Madrid, 28221
Hospital Universitario Carlos Haya
Málaga, Málaga, 29004
Hospital Universitario Central de Asturias
Oviedo, Principality of Asturias, 33012
Clínica Universitaria de Navarra
Pamplona, Navarre, 31003
Complejo Hospitalario Universitario de Santiago
Santiago de Compostela, A Coruña, 15871
Hospital Virgen del Rocío
Seville, Sevilla, 41013
Hospital Universitario Río Hortega
Valladolid, Valladolid, 47004
Hospital Clínico Lozano Blesa
Zaragoza, Zaragoza, 50018
About this study
Official title: Non-interventional, Prospective Study to Evaluate the Impact of CMV Replication Over Hepatitis C Recurrence in Liver Transplant Recipients
The relationship between cytomegalovirus infection and recurrence of hepatitis C in liver transplant recipients remains controversial. Although some studies (Teixeira et al., 2000; Singh et al., 2005)have not found an association between recurrence of hepatitis C and CMV infection, studies such as Rosen et al. show that 50% of patients with CMV infection suffered cirrhosis durig follow-up period, while between not-infected patients the rate was 11%. To clarify this question, a non-interventional study will be carried out in order to assess if CMV replication is a risk factor for graft dysfunction in liver transplant recipients.
- Conditions
- Cytomegalovirus Infection, Hepatitis C
- Keywords
- Cytomegalovirus, Liver transplantation, Hepatitis C virus, Patients who underwent first liver transplantation due to hepatopathy caused by HCV,confirmed by detection of HCV RNA previously to transplantation
- Medical subject headings
- Cytomegalovirus Infections, Hepatitis C
What is being measured
The primary outcome is the main question the study is designed to answer.
Effect of CMV replication over hepatitis C recurrence
viral charge of HCV will be assessed 48 weeks after transplantation
Measured: 48 weeks after transplantation
Secondary outcomes (3)
Effect of CMV replication over fibrosis in graft after Hepatitis C recurrence after transplantation
Measured: 1 year
Effect of CMV recurrence over graft and patient survival
Measured: 1 year
Relationship between viral charge of CMV and HCV during study period
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2011 (estimated)
- Study startMay 2010
- Primary completionMar 2013 (estimated)
- Study completionApr 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cytomegalovirus InfectionStudies of the same condition, open and under way.
- 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
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 179 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sociedad Española de Trasplante Hepático
- Sponsor type
- Research network
- Collaborators
- Roche Farma, S.A
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01473849
- Sponsor's protocol ID
- VHENUS
- Acronym
- VHENUS
- Status last verified
- Dec 2012
- First submitted
- 30 May 2011
- Last updated
- 20 Dec 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Dec 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Non-interventional, Prospective Study to Evaluate the Impact of CMV Replication Over Hepatitis C Recurrence in Liver Transplant Recipients
- ClinicalTrials.gov ID
- NCT01473849
- Acronym / sponsor ID
- VHENUS / VHENUS
- Conditions
- Cytomegalovirus Infection, Hepatitis C
- Keywords
- Cytomegalovirus, Liver transplantation, Hepatitis C virus, Patients who underwent first liver transplantation due to hepatopathy caused by HCV,confirmed by detection of HCV RNA previously to transplantation
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 179 participants (estimated)
- Lead sponsor
- Sociedad Española de Trasplante HepáticoResearch network
- Collaborators
- Roche Farma, S.A
- Study start
- May 2010
- Primary completion
- Mar 2013 (estimated)
- Study completion
- Apr 2013 (estimated)
- First posted
- 17 Nov 2011 (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.
The relationship between cytomegalovirus infection and recurrence of hepatitis C in liver transplant recipients remains controversial. Although some studies (Teixeira et al., 2000; Singh et al., 2005)have not found an association between recurrence of hepatitis C and CMV infection, studies such as Rosen et al. show that 50% of patients with CMV infection suffered cirrhosis durig follow-up period, while between not-infected patients the rate was 11%. To clarify this question, a non-interventional study will be carried out in order to assess if CMV replication is a risk factor for graft dysfunction in liver transplant recipients.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who underwent liver transplantation after hepatopathy caused by HCV
Key inclusion criteria (2 listed)
- Men or women who underwent liver transplantation after hepatopathy caused by HCV, confirmed by pre-transplantation detection of HCV RNA
- Age > 18 years old
Key exclusion criteria (2 listed)
- Patients co-infected with HBV or HIV
- Patients who show other causes of liver disease
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
Effect of CMV replication over hepatitis C recurrence
Time frame: 48 weeks after transplantation
viral charge of HCV will be assessed 48 weeks after transplantation
3 secondary outcomes
Effect of CMV replication over fibrosis in graft after Hepatitis C recurrence after transplantation
Time frame: 1 year
Effect of CMV recurrence over graft and patient survival
Time frame: 1 year
Relationship between viral charge of CMV and HCV during study period
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Dec 2012.
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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.
13 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cytomegalovirus Infection and Hepatitis C, run by Sociedad Española de Trasplante Hepático at 13 sites in Spain.
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 2 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 20 Dec 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 sites in Spain. 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?
Results are not available in the source record.
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?
Effect of CMV replication over hepatitis C recurrence (time frame: 48 weeks after transplantation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 20 Dec 2012.