Cytomegalovirus Hyperimmune Globulin (CMV-Ig) Replacement in Hypogammaglobulinemic Lung Transplant Recipients
June 8, 2010 updated by: The Cleveland Clinic
Does Replacement With CMVIG in Hypogammaglobulinemic Patients Decrease the Rate of Opportunistic Infections and Chronic Rejection?
This is a randomized controlled trial of CMV-Ig in lung transplant recipients at the Cleveland Clinic Foundation who are hypogammaglobulinemic.
Study Overview
Detailed Description
This is a randomized controlled trial of CMV-Ig in lung transplant recipients at the Cleveland Clinic Foundation who are hypogammaglobulinemic.
Study Type
Interventional
Enrollment (Anticipated)
50
Phase
- Phase 2
- Phase 3
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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Ohio
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Cleveland, Ohio, United States, 44195
- Cleveland Clinic Foundation
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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
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Lung transplant
- Hypogammaglobulinemia
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?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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CMV infection
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Jeff T Chapman, MD, The Cleveland Clinic
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
January 1, 2001
Primary Completion (Actual)
January 1, 2006
Study Completion (Actual)
January 1, 2006
Study Registration Dates
First Submitted
August 29, 2005
First Submitted That Met QC Criteria
August 29, 2005
First Posted (Estimate)
August 30, 2005
Study Record Updates
Last Update Posted (Estimate)
June 10, 2010
Last Update Submitted That Met QC Criteria
June 8, 2010
Last Verified
June 1, 2010
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- IRB2953
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.