Back to resultsCytomegalovirus Hyperimmune Globulin (CMV-Ig) Replacement in Hypogammaglobulinemic Lung Transplant Recipients
Primary Purpose
Hypogammaglobulinemia
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
CMV-Ig
Sponsored by
About this trial
This is an interventional prevention trial for Hypogammaglobulinemia focused on measuring Lung transplantation
Eligibility Criteria
Inclusion Criteria: Lung transplant Hypogammaglobulinemia
Sites / Locations
- Cleveland Clinic Foundation
Outcomes
Primary Outcome Measures
CMV infection
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00137748
Brief Title
Cytomegalovirus Hyperimmune Globulin (CMV-Ig) Replacement in Hypogammaglobulinemic Lung Transplant Recipients
Official Title
Does Replacement With CMVIG in Hypogammaglobulinemic Patients Decrease the Rate of Opportunistic Infections and Chronic Rejection?
Study Type
Interventional
2. Study Status
Record Verification Date
June 2010
Overall Recruitment Status
Completed
Study Start Date
January 2001 (undefined)
Primary Completion Date
January 2006 (Actual)
Study Completion Date
January 2006 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
The Cleveland Clinic
4. Oversight
5. 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.
Detailed Description
This is a randomized controlled trial of CMV-Ig in lung transplant recipients at the Cleveland Clinic Foundation who are hypogammaglobulinemic.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypogammaglobulinemia
Keywords
Lung transplantation
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 2, Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
50 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
CMV-Ig
Intervention Description
Drug: CMV-Ig
Primary Outcome Measure Information:
Title
CMV infection
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Lung transplant
Hypogammaglobulinemia
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jeff T Chapman, MD
Organizational Affiliation
The Cleveland Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cleveland Clinic Foundation
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Cytomegalovirus Hyperimmune Globulin (CMV-Ig) Replacement in Hypogammaglobulinemic Lung Transplant Recipients
We'll reach out to this number within 24 hrs