Clinical trial NCT01473849: Impact of Cytomegalovirus (CMV) Replication Over Hepatitis C Recurrence 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 type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Cytomegalovirus Infection
Hepatitis C
Keywords: 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
Lead sponsor: Sociedad Española de Trasplante Hepático
Sponsor class: NETWORK
Collaborators: name: Roche Farma, S.A
First posted: 2011-11-17
Enrollment: 179
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who underwent liver transplantation after hepatopathy caused by HCV

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.


Eligibility 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

Primary outcomes:
measure: Effect of CMV replication over hepatitis C recurrence
timeFrame: 48 weeks after transplantation
Secondary outcomes:
measure: Effect of CMV replication over fibrosis in graft after Hepatitis C recurrence after transplantation
timeFrame: 1 year
measure: Effect of CMV recurrence over graft and patient survival
timeFrame: 1 year
measure: Relationship between viral charge of CMV and HCV during study period
timeFrame: 1 year
Other outcomes:
Locations:
city: Santiago de Compostela
country: Spain
facility: Complejo Hospitalario Universitario de Santiago
state: A Coruña
city: Oviedo
country: Spain
facility: Hospital Universitario Central de Asturias
state: Asturias
city: L'Hospitalet de Llobregat
country: Spain
facility: Hospital de Bellvitge
state: Barcelona
city: Pamplona
country: Spain
facility: Clínica Universitaria de Navarra
state: Navarra
city: Barcelona
country: Spain
facility: Hospital Vall d'Hebron
city: Córdoba
country: Spain
facility: Hospital Reina Sofía
city: Madrid
country: Spain
facility: Hospital General Universitario Gregorio Marañón
city: Madrid
country: Spain
facility: Hospital Ramón y Cajal
city: Madrid
country: Spain
facility: Hospital 12 de Octubre
city: Málaga
country: Spain
facility: Hospital Universitario Carlos Haya
city: Sevilla
country: Spain
facility: Hospital Virgen del Rocío
city: Valladolid
country: Spain
facility: Hospital Universitario Río Hortega
city: Zaragoza
country: Spain
facility: Hospital Clínico Lozano Blesa
Study officials:
References: