NCT01473849

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
179

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started May 2010

Typical duration for all trials

Geographic Reach
1 country

13 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2010

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

May 30, 2011

Completed
6 months until next milestone

First Posted

Study publicly available on registry

November 17, 2011

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2013

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2013

Completed
Last Updated

December 20, 2012

Status Verified

December 1, 2012

Enrollment Period

2.8 years

First QC Date

May 30, 2011

Last Update Submit

December 19, 2012

Conditions

Cytomegalovirus InfectionHepatitis C

Keywords

CytomegalovirusLiver transplantationHepatitis C virusPatients who underwent first liver transplantation due to hepatopathy caused by HCV,confirmed by detection of HCV RNA previously to transplantation

Outcome Measures

Primary Outcomes (1)

  • Effect of CMV replication over hepatitis C recurrence

    viral charge of HCV will be assessed 48 weeks after transplantation

    48 weeks after transplantation

Secondary Outcomes (3)

  • 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

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients who underwent liver transplantation after hepatopathy caused by HCV

You may qualify if:

  • Men or women who underwent liver transplantation after hepatopathy caused by HCV, confirmed by pre-transplantation detection of HCV RNA
  • Age \> 18 years old

You may not qualify if:

  • Patients co-infected with HBV or HIV
  • Patients who show other causes of liver disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (13)

Complejo Hospitalario Universitario de Santiago

Santiago de Compostela, A Coruña, 15871, Spain

Location

Hospital Vall d'Hebron

Barcelona, Barcelona, 08035, Spain

Location

Hospital de Bellvitge

L'Hospitalet de Llobregat, Barcelona, 08907, Spain

Location

Hospital Reina Sofía

Córdoba, Córdoba, 14004, Spain

Location

Hospital General Universitario Gregorio Marañón

Madrid, Madrid, 28009, Spain

Location

Hospital Ramón y Cajal

Madrid, Madrid, 28039, Spain

Location

Hospital 12 de Octubre

Madrid, Madrid, 28221, Spain

Location

Hospital Universitario Carlos Haya

Málaga, Málaga, 29004, Spain

Location

Clínica Universitaria de Navarra

Pamplona, Navarre, 31003, Spain

Location

Hospital Universitario Central de Asturias

Oviedo, Principality of Asturias, 33012, Spain

Location

Hospital Virgen del Rocío

Seville, Sevilla, 41013, Spain

Location

Hospital Universitario Río Hortega

Valladolid, Valladolid, 47004, Spain

Location

Hospital Clínico Lozano Blesa

Zaragoza, Zaragoza, 50018, Spain

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Serum

MeSH Terms

Conditions

Cytomegalovirus InfectionsHepatitis C

Condition Hierarchy (Ancestors)

Herpesviridae InfectionsDNA Virus InfectionsVirus DiseasesInfectionsBlood-Borne InfectionsCommunicable DiseasesHepatitis, Viral, HumanFlaviviridae InfectionsRNA Virus InfectionsHepatitisLiver DiseasesDigestive System Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
NETWORK

Study Record Dates

First Submitted

May 30, 2011

First Posted

November 17, 2011

Study Start

May 1, 2010

Primary Completion

March 1, 2013

Study Completion

April 1, 2013

Last Updated

December 20, 2012

Record last verified: 2012-12

Locations

ES(13)