- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00861900
Immune Mechanisms of Rejection in Human Lung Allografts
June 15, 2018 updated by: Washington University School of Medicine
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.
Study Overview
Status
Completed
Conditions
Study Type
Observational
Enrollment (Actual)
778
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 70 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Any patient who is a candidate for a lung transplant.
Description
Inclusion Criteria:
- Lung transplant recipient.
Exclusion Criteria:
- Pregnant women,
- Prisoners, AND
- Anyone who is unable or unwilling to consent to this study.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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.
|
Lung function is monitored at regular intervals. Patients will be followed for five years.
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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.
|
The subjects are monitored at regular intervals. Patients will be followed for five years.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: Thalachallour Mohanakumar, PhD, Washington University School of Medicine
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 1, 1998
Primary Completion (Actual)
July 1, 2017
Study Completion (Actual)
July 1, 2017
Study Registration Dates
First Submitted
March 13, 2009
First Submitted That Met QC Criteria
March 13, 2009
First Posted (Estimate)
March 16, 2009
Study Record Updates
Last Update Posted (Actual)
June 19, 2018
Last Update Submitted That Met QC Criteria
June 15, 2018
Last Verified
June 1, 2018
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 98-0977-201103312
- HL056643
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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