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Immune Mechanisms of Rejection in Human Lung Allografts

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified July 2009 by Washington University School of Medicine.
Recruitment status was:  Enrolling by invitation
Sponsor:
ClinicalTrials.gov Identifier:
NCT00861900
First Posted: March 16, 2009
Last Update Posted: July 15, 2009
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.
Collaborator:
National Institutes of Health (NIH)
Information provided by:
Washington University School of Medicine
  Purpose
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.

Condition
Bronchiolitis Obliterans

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Immune Mechanisms of Rejection in Human Lung Allografts

Resource links provided by NLM:


Further study details as provided by Washington University School of Medicine:

Primary Outcome Measures:
  • 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. ]

Estimated Enrollment: 360
Study Start Date: January 1998
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Any patient who is a candidate for a lung transplant.
Criteria

Inclusion Criteria:

  • Lung transplant recipient.

Exclusion Criteria:

  • Pregnant women,
  • Prisoners, AND
  • Anyone who is unable or unwilling to consent to this study.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00861900


Sponsors and Collaborators
Washington University School of Medicine
National Institutes of Health (NIH)
Investigators
Principal Investigator: Thalachallour Mohanakumar, PhD Washington University School of Medicine
  More Information

Responsible Party: Mohanakumar, Thalachallour PHD, Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT00861900     History of Changes
Other Study ID Numbers: 98-0977
HL056643
First Submitted: March 13, 2009
First Posted: March 16, 2009
Last Update Posted: July 15, 2009
Last Verified: July 2009

Additional relevant MeSH terms:
Bronchiolitis
Bronchiolitis Obliterans
Bronchitis
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Tract Infections