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Study 15 of 17 for search of: | "Agammaglobulinemia" |
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Sponsors and Collaborators: |
Arcasoy, Selim, M.D. Columbia University Talecris Biotherapeutics |
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Information provided by: | Arcasoy, Selim, M.D. |
ClinicalTrials.gov Identifier: | NCT00115778 |
The purpose of this study is to determine if intravenous immunoglobulin (IVIG) can prevent bacterial infections in lung transplant patients with low serum levels of immunoglobulin.
Condition | Intervention | Phase |
---|---|---|
Hypogammaglobulinemia Lung Transplantation |
Drug: Intravenous immunoglobulin |
Phase II |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Crossover Assignment, Safety/Efficacy Study |
Official Title: | IVIG for Acquired Immunodeficiency in Lung Transplant Patients |
Estimated Enrollment: | 10 |
Study Start Date: | June 2005 |
Estimated Study Completion Date: | December 2009 |
Estimated Primary Completion Date: | November 2009 (Final data collection date for primary outcome measure) |
An increased risk of infection despite intensive antimicrobial prophylaxis is a well-recognized complication of lung transplantation. Recent evidence suggests that immunosuppressive therapy after solid organ transplantation may lead to humoral immunodeficiency due to hypogammaglobulinemia (HGG). In lung transplant recipients with HGG, IVIG therapy offers the potential to significantly decrease the incidence and severity of infections, thereby reducing morbidity and potentially mortality.
Comparison: The investigators are conducting a randomized clinical trial of IVIG versus placebo for lung transplant patients with severe HGG to see if IVIG decreases the number of bacterial infections in these patients.
Ages Eligible for Study: | 12 Years to 75 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: David J Lederer, M.D., M.S. | (212) 305-7771 | dl427@columbia.edu |
United States, New York | |
New York Presbyterian Hospital Lung Transplant Program | Recruiting |
New York, New York, United States, 10032 | |
Contact: David J Lederer, M.D., M.S. 212-305-7771 dl427@columbia.edu | |
Contact: Debbie Rybak 212-305-5836 dr2359@columbia.edu | |
Principal Investigator: Selim M. Arcasoy, M.D. | |
Sub-Investigator: Joshua R Sonett, M.D. | |
Sub-Investigator: Steven M Kawut, M.D., M.S. | |
Sub-Investigator: Jessie S Wilt, M.D. | |
Sub-Investigator: David J Lederer, M.D., M.S. |
Principal Investigator: | Selim M Arcasoy, M.D. | Columbia University |
Responsible Party: | Columbia Unversity ( Selim Arcasoy, MD ) |
Study ID Numbers: | AAAB0431 |
Study First Received: | June 26, 2005 |
Last Updated: | May 6, 2008 |
ClinicalTrials.gov Identifier: | NCT00115778 |
Health Authority: | United States: Institutional Review Board |
Hypogammaglobulinemia Lung Transplantation |
Lymphatic Diseases Antibodies Agammaglobulinemia Immunoglobulins, Intravenous Hematologic Diseases |
Blood Protein Disorders Rho(D) Immune Globulin Lymphoproliferative Disorders Immunologic Deficiency Syndromes Immunoglobulins |
Immunologic Factors Immune System Diseases Physiological Effects of Drugs Pharmacologic Actions |