NCT00436384

Brief Summary

Cytomegalovirus (CMV) is a common cause of illness in patients who have undergone a transplant. Serious infections due to CMV can affect many parts of the body including the lungs, the gut, and the liver. Since transplant recipients are at risk for CMV or have evidence of infection with CMV, they are given an antiviral drug (usually ganciclovir or valganciclovir). Despite this, there are a chance that CMV infection may cause problems in the future. The purpose of this study is to assess how well patients'immune systems responds to the CMV virus, so that in the future it may be possible to predict which patients are at highest risk of CMV.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
150

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Nov 2005

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

November 1, 2005

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

February 15, 2007

Completed
4 days until next milestone

First Posted

Study publicly available on registry

February 19, 2007

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2008

Completed
Last Updated

April 16, 2008

Status Verified

February 1, 2007

Enrollment Period

2.3 years

First QC Date

February 15, 2007

Last Update Submit

April 15, 2008

Conditions

Transplant

Keywords

liver transplantlung transplantkidney transplantheart transplantCMV CMI

Interventions

Monitoring-blood samples drawn for CMV testingPROCEDURE

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • CMV D+/R- liver, kidney and heart recipient
  • CMV R+ liver,kidney and heart recipients who have received thymoglobulin induction therapy.
  • D+/R- and R+ lung transplant recipients.
  • Able to give written informed consent
  • Are willing and able to comply with the protocol
  • Age \>=18 years

You may not qualify if:

  • Patient unwilling or unable to give informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Health Network

Toronto, Ontario, M5G 2N2, Canada

Location

Study Officials

  • Atul Humar, MD

    University Health Network, Toronto

    PRINCIPAL INVESTIGATOR

  • Deepali Kumar, MD

    University Health Network, Toronto

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Sponsor Type
OTHER

Study Record Dates

First Submitted

February 15, 2007

First Posted

February 19, 2007

Study Start

November 1, 2005

Primary Completion

March 1, 2008

Study Completion

March 1, 2008

Last Updated

April 16, 2008

Record last verified: 2007-02

Locations

CA(1)