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OpenTrials
Completed

NCT Number: NCT00861900

Immune Mechanisms of Rejection in Human Lung Allografts

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.

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Key information

Conditions

Bronchiolitis Obliterans Bronchial Diseases Bronchiolitis Bronchitis Lung Diseases Lung Diseases, Obstructive Respiratory Tract Diseases

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Lung transplant recipient.

Exclusion criteria

  • Pregnant women,
  • Prisoners, AND
  • Anyone who is unable or unwilling to consent to this study.

Treatment and study plan

Primary outcomes

  1. 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 outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Washington University School of Medicine

Other

Collaborators

  • National Institutes of Health (NIH)

Registry information

Important dates

Study start
1998
Primary completion
2017
Study completion
2017
First posted
Mar 16, 2009
Registry last updated
Jun 19, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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