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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2012 by Sociedad Española de Trasplante Hepático.
Recruitment status was  Active, not recruiting
Roche Farma, S.A
Information provided by:
Sociedad Española de Trasplante Hepático Identifier:
First received: May 30, 2011
Last updated: December 19, 2012
Last verified: December 2012
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.

Cytomegalovirus Infection
Hepatitis C

Study Type: Observational
Study Design: 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

Resource links provided by NLM:

Further study details as provided by Sociedad Española de Trasplante Hepático:

Primary Outcome Measures:
  • Effect of CMV replication over hepatitis C recurrence [ Time Frame: 48 weeks after transplantation ] [ Designated as safety issue: No ]
    viral charge of HCV will be assessed 48 weeks after transplantation

Secondary Outcome Measures:
  • Effect of CMV replication over fibrosis in graft after Hepatitis C recurrence after transplantation [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • Effect of CMV recurrence over graft and patient survival [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • Relationship between viral charge of CMV and HCV during study period [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples Without DNA

Estimated Enrollment: 179
Study Start Date: May 2010
Estimated Study Completion Date: April 2013
Estimated Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
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Please refer to this study by its identifier: 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

No publications provided

Responsible Party: Dr. Manuel de la Mata García, Sociedad Española de Transplante Hepático Identifier: NCT01473849     History of Changes
Other Study ID Numbers: VHENUS 
Study First Received: May 30, 2011
Last Updated: December 19, 2012
Health Authority: Spain: Ethics Committee

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:
Cytomegalovirus Infections
Hepatitis A
Hepatitis C
DNA Virus Infections
Digestive System Diseases
Enterovirus Infections
Flaviviridae Infections
Hepatitis, Viral, Human
Herpesviridae Infections
Liver Diseases
Picornaviridae Infections
RNA Virus Infections
Virus Diseases processed this record on February 08, 2016