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

NCT ID: NCT01473849

Last Updated: 2012-12-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

179 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-05-31

Study Completion Date

2013-04-30

Brief Summary

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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

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Conditions

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Cytomegalovirus Infection Hepatitis C

Keywords

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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

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Roche Farma, S.A

INDUSTRY

Sponsor Role collaborator

Sociedad Española de Trasplante Hepático

NETWORK

Sponsor Role lead

Responsible Party

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Sociedad Española de Transplante Hepático

Locations

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Complejo Hospitalario Universitario de Santiago

Santiago de Compostela, A Coruña, Spain

Site Status

Hospital Vall d'Hebron

Barcelona, Barcelona, Spain

Site Status

Hospital de Bellvitge

L'Hospitalet de Llobregat, Barcelona, Spain

Site Status

Hospital Reina Sofía

Córdoba, Córdoba, Spain

Site Status

Hospital General Universitario Gregorio Marañón

Madrid, Madrid, Spain

Site Status

Hospital Ramón y Cajal

Madrid, Madrid, Spain

Site Status

Hospital 12 de Octubre

Madrid, Madrid, Spain

Site Status

Hospital Universitario Carlos Haya

Málaga, Málaga, Spain

Site Status

Clínica Universitaria de Navarra

Pamplona, Navarre, Spain

Site Status

Hospital Universitario Central de Asturias

Oviedo, Principality of Asturias, Spain

Site Status

Hospital Virgen del Rocío

Seville, Sevilla, Spain

Site Status

Hospital Universitario Río Hortega

Valladolid, Valladolid, Spain

Site Status

Hospital Clínico Lozano Blesa

Zaragoza, Zaragoza, Spain

Site Status

Countries

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Spain

Other Identifiers

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VHENUS

Identifier Type: -

Identifier Source: org_study_id