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

This study has been completed.
Information provided by:
The Cleveland Clinic Identifier:
First received: August 29, 2005
Last updated: June 8, 2010
Last verified: June 2010
This is a randomized controlled trial of CMV-Ig in lung transplant recipients at the Cleveland Clinic Foundation who are hypogammaglobulinemic.

Condition Intervention Phase
Drug: CMV-Ig
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Does Replacement With CMVIG in Hypogammaglobulinemic Patients Decrease the Rate of Opportunistic Infections and Chronic Rejection?

Resource links provided by NLM:

Further study details as provided by The Cleveland Clinic:

Primary Outcome Measures:
  • CMV infection [ Designated as safety issue: No ]

Estimated Enrollment: 50
Study Start Date: January 2001
Study Completion Date: January 2006
Primary Completion Date: January 2006 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: CMV-Ig
    Drug: CMV-Ig
Detailed Description:
This is a randomized controlled trial of CMV-Ig in lung transplant recipients at the Cleveland Clinic Foundation who are hypogammaglobulinemic.

Ages Eligible for Study:   Child, Adult, Senior
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Lung transplant
  • Hypogammaglobulinemia
  Contacts and Locations
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Please refer to this study by its identifier: NCT00137748

United States, Ohio
Cleveland Clinic Foundation
Cleveland, Ohio, United States, 44195
Sponsors and Collaborators
The Cleveland Clinic
Principal Investigator: Jeff T Chapman, MD The Cleveland Clinic
  More Information Identifier: NCT00137748     History of Changes
Other Study ID Numbers: IRB2953 
Study First Received: August 29, 2005
Last Updated: June 8, 2010
Health Authority: United States: Institutional Review Board

Keywords provided by The Cleveland Clinic:
Lung transplantation

Additional relevant MeSH terms:
Opportunistic Infections
Virus Diseases
Parasitic Diseases
Blood Protein Disorders
Hematologic Diseases
Lymphoproliferative Disorders
Lymphatic Diseases
Immunologic Deficiency Syndromes
Immune System Diseases processed this record on October 25, 2016