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

• Conditions: Hepatitis C; Cytomegalovirus Infection

• Registration Number: NCT01473849
• Lead Sponsor: Sociedad Española de Trasplante Hepático

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-05
• Study First Submitted: 2011-05-30
• Study First Submitted QC: 2011-11-16
• Study First Posted: 2011-11-17
• Status Verified: 2012-12
• Last Update Submitted: 2012-12-19
• Last Update Posted: 2012-12-20
• Primary Completion: 2013-03
• Study Completion: 2013-04

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 179

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Effect of CMV replication over hepatitis C recurrence	48 weeks after transplantation	viral charge of HCV will be assessed 48 weeks after transplantation

Secondary Outcome Measures

Name	Time	Method
Effect of CMV replication over fibrosis in graft after Hepatitis C recurrence after transplantation	1 year
Effect of CMV recurrence over graft and patient survival	1 year
Relationship between viral charge of CMV and HCV during study period	1 year

Trial Locations

Locations (13)

Hospital Universitario Carlos Haya; 🇪🇸 Málaga, Spain

Hospital Vall d'Hebron; 🇪🇸 Barcelona, Spain

Hospital de Bellvitge; 🇪🇸 L'Hospitalet de Llobregat, Barcelona, Spain

Hospital Ramón y Cajal; 🇪🇸 Madrid, Spain

Hospital Virgen del Rocío; 🇪🇸 Sevilla, Spain

Hospital Reina Sofía; 🇪🇸 Córdoba, Spain

Hospital Clínico Lozano Blesa; 🇪🇸 Zaragoza, Spain

Hospital 12 de Octubre; 🇪🇸 Madrid, Spain

Hospital Universitario Central de Asturias; 🇪🇸 Oviedo, Asturias, Spain

Clínica Universitaria de Navarra; 🇪🇸 Pamplona, Navarra, Spain

Hospital Universitario Río Hortega; 🇪🇸 Valladolid, Spain

Hospital General Universitario Gregorio Marañón; 🇪🇸 Madrid, Spain

Complejo Hospitalario Universitario de Santiago; 🇪🇸 Santiago de Compostela, A Coruña, Spain