NCT00861900

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
778

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 1998

Longer than P75 for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 1998

Completed
11.2 years until next milestone

First Submitted

Initial submission to the registry

March 13, 2009

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 16, 2009

Completed
8.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2017

Completed
Last Updated

June 19, 2018

Status Verified

June 1, 2018

Enrollment Period

19.5 years

First QC Date

March 13, 2009

Last Update Submit

June 15, 2018

Conditions

Bronchiolitis Obliterans

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • 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.

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Any patient who is a candidate for a lung transplant.

You may qualify if:

  • Lung transplant recipient.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Bronchiolitis Obliterans

Condition Hierarchy (Ancestors)

BronchiolitisBronchitisBronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung Diseases

Study Officials

  • Thalachallour Mohanakumar, PhD

    Washington University School of Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 13, 2009

First Posted

March 16, 2009

Study Start

January 1, 1998

Primary Completion

July 1, 2017

Study Completion

July 1, 2017

Last Updated

June 19, 2018

Record last verified: 2018-06