Overview

This trial is active, not recruiting.

Conditions cytomegalovirus infection, hepatitis c
Sponsor Sociedad Española de Trasplante Hepático
Collaborator Roche Farma, S.A
Start date May 2010
End date March 2013
Trial size 179 participants
Trial identifier NCT01473849, VHENUS

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model cohort
Time perspective prospective

Primary Outcomes

Measure
Effect of CMV replication over hepatitis C recurrence
time frame: 48 weeks after transplantation

Secondary Outcomes

Measure
Effect of CMV replication over fibrosis in graft after Hepatitis C recurrence after transplantation
time frame: 1 year
Effect of CMV recurrence over graft and patient survival
time frame: 1 year
Relationship between viral charge of CMV and HCV during study period
time frame: 1 year

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

Official title Non-interventional, Prospective Study to Evaluate the Impact of CMV Replication Over Hepatitis C Recurrence in Liver Transplant Recipients
Trial information was received from ClinicalTrials.gov and was last updated in December 2012.
Information provided to ClinicalTrials.gov by Sociedad Española de Trasplante Hepático.