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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Roche Farma, S.A
Information provided by:
Sociedad Española de Trasplante Hepático
ClinicalTrials.gov Identifier:
NCT01473849
First received: May 30, 2011
Last updated: December 19, 2012
Last verified: December 2012
  Purpose

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
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

Serum


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)
  Eligibility

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

Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01473849

Locations
Spain
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
ClinicalTrials.gov 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:
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

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

ClinicalTrials.gov processed this record on July 24, 2014