Cytomegalovirus Infection, Hepatitis C
Conditions
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
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.
Interventions
None listed
Sponsors
Roche Farma, S.A
Sociedad Española de Trasplante Hepático
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Effect of CMV replication over hepatitis C recurrence | 48 weeks after transplantation | viral charge of HCV will be assessed 48 weeks after transplantation |
Secondary
| Measure | Time frame |
|---|---|
| Effect of CMV replication over fibrosis in graft after Hepatitis C recurrence after transplantation | 1 year |
| Effect of CMV recurrence over graft and patient survival | 1 year |
| Relationship between viral charge of CMV and HCV during study period | 1 year |
Countries
Spain
Outcome results
None listed