Cytomegalovirus Hyperimmune Globulin (CMV-Ig) Replacement in Hypogammaglobulinemic Lung Transplant Recipients

Hypogammaglobulinemia Clinical Trial

Official title:

Does Replacement With CMVIG in Hypogammaglobulinemic Patients Decrease the Rate of Opportunistic Infections and Chronic Rejection?

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00137748
• Other study ID #: IRB2953
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: August 29, 2005
• Last updated: June 8, 2010
• Start date: January 2001
• Est. completion date: January 2006

Study information

• Verified date: June 2010
• Source: The Cleveland Clinic
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

This is a randomized controlled trial of CMV-Ig in lung transplant recipients at the Cleveland Clinic Foundation who are hypogammaglobulinemic.

Description:

This is a randomized controlled trial of CMV-Ig in lung transplant recipients at the Cleveland Clinic Foundation who are hypogammaglobulinemic.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: January 2006
• Est. primary completion date: January 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Lung transplant

• Hypogammaglobulinemia

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Hypogammaglobulinemia

Intervention

Drug:
• CMV-Ig
Drug: CMV-Ig

Locations

Country	Name	City	State
United States	Cleveland Clinic Foundation	Cleveland	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
The Cleveland Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	CMV infection			No