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Impact of Cytomegalovirus (CMV) Replication Over Hepatitis C Recurrence in Liver Transplant Recipients (VHENUS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01473849
Recruitment Status : Unknown
Verified December 2012 by Sociedad Española de Trasplante Hepático.
Recruitment status was:  Active, not recruiting
First Posted : November 17, 2011
Last Update Posted : December 20, 2012
Information provided by:

Study Description
Brief 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. 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.

Condition or disease
Cytomegalovirus Infection Hepatitis C

Study Design

Study Type : Observational
Estimated Enrollment : 179 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Non-interventional, Prospective Study to Evaluate the Impact of CMV Replication Over Hepatitis C Recurrence in Liver Transplant Recipients
Study Start Date : May 2010
Estimated Primary Completion Date : March 2013
Estimated Study Completion Date : April 2013

Groups and Cohorts

Outcome Measures

Primary Outcome Measures :
  1. 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

Secondary Outcome Measures :
  1. Effect of CMV replication over fibrosis in graft after Hepatitis C recurrence after transplantation [ Time Frame: 1 year ]
  2. Effect of CMV recurrence over graft and patient survival [ Time Frame: 1 year ]
  3. Relationship between viral charge of CMV and HCV during study period [ Time Frame: 1 year ]

Biospecimen Retention:   Samples Without DNA

Eligibility Criteria

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients who underwent liver transplantation after hepatopathy caused by HCV

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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01473849

Complejo Hospitalario Universitario de Santiago
Santiago de Compostela, A Coruña, Spain, 15871
Hospital Universitario Central de Asturias
Oviedo, Asturias, Spain, 33012
Hospital de Bellvitge
L'Hospitalet de Llobregat, Barcelona, Spain, 08907
Clínica Universitaria de Navarra
Pamplona, Navarra, Spain, 31003
Hospital Vall d'Hebron
Barcelona, Spain, 08035
Hospital Reina Sofía
Córdoba, Spain, 14004
Hospital General Universitario Gregorio Marañón
Madrid, Spain, 28009
Hospital Ramón y Cajal
Madrid, Spain, 28039
Hospital 12 de Octubre
Madrid, Spain, 28221
Hospital Universitario Carlos Haya
Málaga, Spain, 29004
Hospital Virgen del Rocío
Sevilla, Spain, 41013
Hospital Universitario Río Hortega
Valladolid, Spain, 47004
Hospital Clínico Lozano Blesa
Zaragoza, Spain, 50018
Sponsors and Collaborators
Sociedad Española de Trasplante Hepático
Roche Farma, S.A
More Information

Responsible Party: Dr. Manuel de la Mata García, Sociedad Española de Transplante Hepático
ClinicalTrials.gov Identifier: NCT01473849     History of Changes
Other Study ID Numbers: VHENUS
First Posted: November 17, 2011    Key Record Dates
Last Update Posted: December 20, 2012
Last Verified: December 2012

Keywords provided by Sociedad Española de Trasplante Hepático:
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

Additional relevant MeSH terms:
Hepatitis A
Hepatitis C
Cytomegalovirus Infections
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Flaviviridae Infections
Disease Attributes
Pathologic Processes
Herpesviridae Infections
DNA Virus Infections