Immune Mechanisms of Rejection in Human Lung Allografts

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT00861900

Enrollment

778

Registered

2009-03-16

Start date

1998-01-31

Completion date

2017-07-31

Last updated

2018-06-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bronchiolitis Obliterans

Brief summary

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 70 Years

Healthy volunteers

Inclusion criteria

* Lung transplant recipient.

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
The primary efficacy event is the change in pulmonary function testing values (FEV1).	Lung function is monitored at regular intervals. Patients will be followed for five years.

Secondary

Measure	Time frame
Secondary efficacy measurements include allograft and patient survival, incidence of BOS and Obliterative bronchiolitis.	The subjects are monitored at regular intervals. Patients will be followed for five years.

Outcome results