Bronchiolitis ObliteransNCT00861900
Immune Mechanisms of Rejection in Human Lung Allografts
An observational study of Bronchiolitis Obliterans, run by Washington University School of Medicine.
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). Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Bronchiolitis Obliterans
- How many people
- 778 participants
- Where
- No sites listed yet
- Study dates
- Jan 1998to Jul 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Any patient who is a candidate for a lung transplant.
Who may be able to join
- Lung transplant recipient.
Who cannot join
- Pregnant women,
- Prisoners, AND
- Anyone who is unable or unwilling to consent to this study.
About this study
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.
- Conditions
- Bronchiolitis Obliterans
- Medical subject headings
- Bronchiolitis Obliterans
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary efficacy event is the change in pulmonary function testing values (FEV1).
Measured: 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.
Measured: The subjects are monitored at regular intervals. Patients will be followed for five years.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2009 (estimated)
- Study startJan 1998
- Primary completionJul 2017
- Study completionJul 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bronchiolitis ObliteransStudies of the same condition, open and under way.
- More trials run by Washington University School of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 778 participants (actual)
Sponsor and investigators
- Lead sponsor
- Washington University School of Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH)
- Responsible party
- Sponsor
- Investigators
- Thalachallour Mohanakumar, PhD, Principal investigator, Washington University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00861900
- Sponsor's protocol ID
- 98-0977-201103312
- Other IDs
- HL056643
- Status last verified
- Jun 2018
- First submitted
- 13 Mar 2009
- Last updated
- 19 Jun 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immune Mechanisms of Rejection in Human Lung Allografts
- ClinicalTrials.gov ID
- NCT00861900
- Acronym / sponsor ID
- 98-0977-201103312
- Conditions
- Bronchiolitis Obliterans
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 778 participants (actual)
- Lead sponsor
- Washington University School of MedicineUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH)
- Study start
- Jan 1998 (actual)
- Primary completion
- Jul 2017 (actual)
- Study completion
- Jul 2017 (actual)
- First posted
- 16 Mar 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Any patient who is a candidate for a lung transplant.
Key inclusion criteria (1 listed)
- Lung transplant recipient.
Key exclusion criteria (3 listed)
- Pregnant women,
- Prisoners, AND
- Anyone who is unable or unwilling to consent to this study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
1 secondary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jun 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Thalachallour Mohanakumar, PhD principal investigator
Washington University School of Medicine
Questions about this trial
What is this clinical trial studying?
An observational study of Bronchiolitis Obliterans, run by Washington University School of Medicine.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Jun 2018. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Jun 2018.