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

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

      • Barcelona, Spain, 08035
        • Hospital Vall d'Hebron
      • Córdoba, Spain, 14004
        • Hospital Reina Sofía
      • Madrid, Spain, 28009
        • Hospital General Universitario Gregorio Marañon
      • Madrid, Spain, 28039
        • Hospital Ramon y Cajal
      • Madrid, Spain, 28221
        • Hospital 12 de Octubre
      • Málaga, Spain, 29004
        • Hospital Universitario Carlos Haya
      • Sevilla, Spain, 41013
        • Hospital Virgen del Rocío
      • Valladolid, Spain, 47004
        • Hospital Universitario Rio Hortega
      • Zaragoza, Spain, 50018
        • Hospital Clinico Lozano Blesa
    • A Coruña
      • Santiago de Compostela, A Coruña, Spain, 15871
        • Complejo Hospitalario Universitario de Santiago
    • Asturias
      • Oviedo, Asturias, Spain, 33012
        • Hospital Universitario Central de Asturias
    • Barcelona
      • L'Hospitalet de Llobregat, Barcelona, Spain, 08907
        • Hospital de Bellvitge
    • Navarra
      • Pamplona, Navarra, Spain, 31003
        • Clinica Universitaria de Navarra

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
48 weeks after transplantation

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
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.

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

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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