Cytomegalovirus Hyperimmune Globulin (CMV-Ig) Replacement in Hypogammaglobulinemic Lung Transplant Recipients
Sponsor
The Cleveland Clinic (Other)
Overall Status
Completed
CT.gov ID
NCT00137748
Collaborator
(none)
50
1
60
0.8
Study Details
Study Description
Brief Summary
This is a randomized controlled trial of CMV-Ig in lung transplant recipients at the Cleveland Clinic Foundation who are hypogammaglobulinemic.
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
Phase 2/Phase 3 |
Detailed Description
This is a randomized controlled trial of CMV-Ig in lung transplant recipients at the Cleveland Clinic Foundation who are hypogammaglobulinemic.
Study Design
Study Type:
Interventional
Anticipated Enrollment
:
50 participants
Allocation:
Randomized
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Prevention
Official Title:
Does Replacement With CMVIG in Hypogammaglobulinemic Patients Decrease the Rate of Opportunistic Infections and Chronic Rejection?
Study Start Date
:
Jan 1, 2001
Actual Primary Completion Date
:
Jan 1, 2006
Actual Study Completion Date
:
Jan 1, 2006
Outcome Measures
Primary Outcome Measures
- CMV infection []
Eligibility Criteria
Criteria
Ages Eligible for Study:
N/A
and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
-
Lung transplant
-
Hypogammaglobulinemia
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | Cleveland Clinic Foundation | Cleveland | Ohio | United States | 44195 |
Sponsors and Collaborators
- The Cleveland Clinic
Investigators
- Principal Investigator: Jeff T Chapman, MD, The Cleveland Clinic
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
,
,
ClinicalTrials.gov Identifier:
NCT00137748
Other Study ID Numbers:
- IRB2953
First Posted:
Aug 30, 2005
Last Update Posted:
Jun 10, 2010
Last Verified:
Jun 1, 2010