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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT01473849
Other study ID # VHENUS
Secondary ID
Status Active, not recruiting
Phase N/A
First received May 30, 2011
Last updated December 19, 2012
Start date May 2010
Est. completion date April 2013

Study information

Verified date December 2012
Source Sociedad Española de Trasplante Hepático
Contact n/a
Is FDA regulated No
Health authority Spain: Ethics Committee
Study type Observational

Clinical Trial 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.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 179
Est. completion date April 2013
Est. primary completion date March 2013
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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

Observational Model: Cohort, Time Perspective: Prospective


Locations

Country Name City State
Spain Hospital Vall d'Hebron Barcelona
Spain Hospital Reina Sofía Córdoba
Spain Hospital de Bellvitge L'Hospitalet de Llobregat Barcelona
Spain Hospital 12 de Octubre Madrid
Spain Hospital General Universitario Gregorio Marañón Madrid
Spain Hospital Ramón y Cajal Madrid
Spain Hospital Universitario Carlos Haya Málaga
Spain Hospital Universitario Central de Asturias Oviedo Asturias
Spain Clínica Universitaria de Navarra Pamplona Navarra
Spain Complejo Hospitalario Universitario de Santiago Santiago de Compostela A Coruña
Spain Hospital Virgen del Rocío Sevilla
Spain Hospital Universitario Río Hortega Valladolid
Spain Hospital Clínico Lozano Blesa Zaragoza

Sponsors (2)

Lead Sponsor Collaborator
Sociedad Española de Trasplante Hepático Roche Farma, S.A

Country where clinical trial is conducted

Spain, 

Outcome

Type Measure Description Time frame Safety issue
Primary Effect of CMV replication over hepatitis C recurrence viral charge of HCV will be assessed 48 weeks after transplantation 48 weeks after transplantation No
Secondary Effect of CMV replication over fibrosis in graft after Hepatitis C recurrence after transplantation 1 year No
Secondary Effect of CMV recurrence over graft and patient survival 1 year No
Secondary Relationship between viral charge of CMV and HCV during study period 1 year No
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