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

Hepatitis C Clinical Trial

— VHENUS  

Official title:

Non-interventional, Prospective Study to Evaluate the Impact of CMV Replication Over Hepatitis C Recurrence in Liver Transplant Recipients

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01473849
• Other study ID #: VHENUS
• 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

Related Conditions & MeSH terms

• Cytomegalovirus Infection
• Cytomegalovirus Infections
• Hepatitis
• Hepatitis A
• Hepatitis C

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