Immune Mechanisms of Rejection in Human Lung Allografts

Bronchiolitis Obliterans Clinical Trial

Official title:

Immune Mechanisms of Rejection in Human Lung Allografts

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00861900
• Other study ID #: 98-0977-201103312
• Secondary ID: HL056643
• Status: Completed
• Start date: January 1998
• Est. completion date: July 2017

Study information

• Verified date: June 2018
• Source: Washington University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 778
• Est. completion date: July 2017
• Est. primary completion date: July 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• Lung transplant recipient.

Exclusion Criteria:

• Pregnant women,

• Prisoners, AND

• Anyone who is unable or unwilling to consent to this study.

Related Conditions & MeSH terms

• Bronchiolitis
• Bronchiolitis Obliterans

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Washington University School of Medicine	National Institutes of Health (NIH)

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.