Immune Mechanisms of Rejection in Human Lung Allografts
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government.
Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00861900
Verified July 2009 by Washington University School of Medicine. Recruitment status was: Enrolling by invitation
The investigators have obtained compelling evidence that the development of anti-human leukocyte antigen (anti-HLA) antibodies against mismatched donor antigens significantly correlates with the development of bronchiolitis obliterans (BOS). Further, these anti-HLA antibodies are developed at least 15 months prior to any clinical evidence of BOS. This lag period between the development of anti-HLA antibodies and the onset of BOS gives us an opportunity to intervene to delay and/or prevent the development of BOS.
The primary efficacy event is the change in pulmonary function testing values (FEV1). [ Time Frame: Lung function is monitored at regular intervals. Patients will be followed for five years. ]
Secondary Outcome Measures
Secondary efficacy measurements include allograft and patient survival, incidence of BOS and Obliterative bronchiolitis. [ Time Frame: The subjects are monitored at regular intervals. Patients will be followed for five years. ]
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study:
18 Years to 70 Years (Adult, Senior)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
Any patient who is a candidate for a lung transplant.
Lung transplant recipient.
Anyone who is unable or unwilling to consent to this study.