- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00436384
Cell Mediated Immunity and the Prediction of CMV Infection In Solid Organ Transplant Recipients
April 15, 2008 updated by: University Health Network, Toronto
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment
150
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Ontario
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Toronto, Ontario, Canada, M5G 2N2
- University Health Network
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
Male or female patients who fulfill the following criteria are eligible for inclusion.
- 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
Exclusion Criteria:
- Patient unwilling or unable to give informed consent
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: Atul Humar, MD, University Health Network, Toronto
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
November 1, 2005
Primary Completion (Actual)
March 1, 2008
Study Completion (Actual)
March 1, 2008
Study Registration Dates
First Submitted
February 15, 2007
First Submitted That Met QC Criteria
February 16, 2007
First Posted (Estimate)
February 19, 2007
Study Record Updates
Last Update Posted (Estimate)
April 16, 2008
Last Update Submitted That Met QC Criteria
April 15, 2008
Last Verified
February 1, 2007
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 05-0265-AE
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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