- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01473849
Impact of Cytomegalovirus (CMV) Replication Over Hepatitis C Recurrence in Liver Transplant Recipients (VHENUS)
December 19, 2012 updated by: Sociedad Española de Trasplante Hepático
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.
Study Overview
Status
Unknown
Conditions
Study Type
Observational
Enrollment (Anticipated)
179
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Barcelona, Spain, 08035
- Hospital Vall d'Hebron
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Córdoba, Spain, 14004
- Hospital Reina Sofía
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Madrid, Spain, 28009
- Hospital General Universitario Gregorio Marañon
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Madrid, Spain, 28039
- Hospital Ramon y Cajal
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Madrid, Spain, 28221
- Hospital 12 de Octubre
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Málaga, Spain, 29004
- Hospital Universitario Carlos Haya
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Sevilla, Spain, 41013
- Hospital Virgen del Rocío
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Valladolid, Spain, 47004
- Hospital Universitario Rio Hortega
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Zaragoza, Spain, 50018
- Hospital Clinico Lozano Blesa
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A Coruña
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Santiago de Compostela, A Coruña, Spain, 15871
- Complejo Hospitalario Universitario de Santiago
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Asturias
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Oviedo, Asturias, Spain, 33012
- Hospital Universitario Central de Asturias
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Barcelona
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L'Hospitalet de Llobregat, Barcelona, Spain, 08907
- Hospital de Bellvitge
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Navarra
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Pamplona, Navarra, Spain, 31003
- Clinica Universitaria de Navarra
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Patients who underwent liver transplantation after hepatopathy caused by HCV
Description
Inclusion Criteria:
- Men or women who underwent liver transplantation after hepatopathy caused by HCV, confirmed by pre-transplantation detection of HCV RNA
- Age > 18 years old
Exclusion Criteria:
- Patients co-infected with HBV or HIV
- Patients who show other causes of liver disease
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
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48 weeks after transplantation
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Effect of CMV replication over fibrosis in graft after Hepatitis C recurrence after transplantation
Time Frame: 1 year
|
1 year
|
Effect of CMV recurrence over graft and patient survival
Time Frame: 1 year
|
1 year
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Relationship between viral charge of CMV and HCV during study period
Time Frame: 1 year
|
1 year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
May 1, 2010
Primary Completion (Anticipated)
March 1, 2013
Study Completion (Anticipated)
April 1, 2013
Study Registration Dates
First Submitted
May 30, 2011
First Submitted That Met QC Criteria
November 16, 2011
First Posted (Estimate)
November 17, 2011
Study Record Updates
Last Update Posted (Estimate)
December 20, 2012
Last Update Submitted That Met QC Criteria
December 19, 2012
Last Verified
December 1, 2012
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Digestive System Diseases
- Pathologic Processes
- RNA Virus Infections
- Virus Diseases
- Infections
- Blood-Borne Infections
- Communicable Diseases
- Disease Attributes
- Liver Diseases
- Flaviviridae Infections
- Hepatitis, Viral, Human
- DNA Virus Infections
- Enterovirus Infections
- Picornaviridae Infections
- Herpesviridae Infections
- Hepatitis
- Hepatitis A
- Hepatitis C
- Recurrence
- Cytomegalovirus Infections
Other Study ID Numbers
- VHENUS
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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