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B Cell Targeted Induction to Improve Outcomes in Pediatric Lung Transplantation (CTOTC-08)
In this study, doctors are trying to see if a study drug called rituximab (Rituxan®) will lower the number of B cells in the body. Doctors are also trying to see if decreasing B cells with rituximab (Rituxan®) can prevent injury to the transplanted lung. This treatment has been studied in other types of solid organ transplants.
Patients who receive a lung transplant are at risk for rejection of the transplanted lung(s). Rejection occurs when the new lung triggers the body's defense (immune) system. When the immune system is triggered special cells are sent out to destroy the new lung and eventually the lung may not be able to function as it should. These special cells include B cells. B cells are an important part of the immune system and help the body fight infection. One way B cells fight infection is by producing antibodies. B cells and the antibodies they produce are involved in some kinds of rejection after organ transplantation.
Age
0 - 21 years
Sex
ALL
Healthy Volunteers
No
Stanford University
Palo Alto, California, United States
Children's Hospital Boston
Boston, Massachusetts, United States
Washington University
St Louis, Missouri, United States
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States
Nationwide Children's Hospital
Columbus, Ohio, United States
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States
Texas Children's Hospital
Houston, Texas, United States
Start Date
January 22, 2015
Primary Completion Date
June 30, 2019
Completion Date
June 30, 2019
Last Updated
October 26, 2021
45
ACTUAL participants
Rituximab (Rituxan®)
BIOLOGICAL
Placebo
BIOLOGICAL
Lead Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
Collaborators
NCT07046910
NCT05837663
NCT07235683
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
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