Hepatitis C Clinical Trial
— VHENUSOfficial title:
Non-interventional, Prospective Study to Evaluate the Impact of CMV Replication Over Hepatitis C Recurrence in Liver Transplant Recipients
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 |
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.
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 |
Observational Model: Cohort, Time Perspective: Prospective
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 |
Lead Sponsor | Collaborator |
---|---|
Sociedad Española de Trasplante Hepático | Roche Farma, S.A |
Spain,
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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