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

Condition(s) targeted: Cytomegalovirus Infection; Hepatitis C

Phase: N/A

Status: Active, not recruiting

Sponsored by: Sociedad Española de Trasplante Hepático

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.

Official title: Non-interventional, Prospective Study to Evaluate the Impact of CMV Replication Over Hepatitis C Recurrence in Liver Transplant Recipients

Study design: Observational Model: Cohort, Time Perspective: Prospective

Primary outcome: Effect of CMV replication over hepatitis C recurrence

Secondary outcome:

Effect of CMV replication over fibrosis in graft after Hepatitis C recurrence after transplantation

Effect of CMV recurrence over graft and patient survival

Relationship between viral charge of CMV and HCV during study period

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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

Hospital Vall d'Hebron, Barcelona 08035, Spain

Hospital Reina Sofía, Córdoba 14004, Spain

Hospital 12 de Octubre, Madrid 28221, Spain

Hospital General Universitario Gregorio Marañón, Madrid 28009, Spain

Hospital Ramón y Cajal, Madrid 28039, Spain

Hospital Universitario Carlos Haya, Málaga 29004, Spain

Hospital Virgen del Rocío, Sevilla 41013, Spain

Hospital Universitario Río Hortega, Valladolid 47004, Spain

Hospital Clínico Lozano Blesa, Zaragoza 50018, Spain

Complejo Hospitalario Universitario de Santiago, Santiago de Compostela, A Coruña 15871, Spain

Hospital Universitario Central de Asturias, Oviedo, Asturias 33012, Spain

Hospital de Bellvitge, L'Hospitalet de Llobregat, Barcelona 08907, Spain

Clínica Universitaria de Navarra, Pamplona, Navarra 31003, Spain

Starting date: May 2010
Last updated: December 19, 2012