Status:
COMPLETED
A Retrospective Chart Review Study of Patients With Chronic Lung Allograft Dysfunction-Bronchiolitis Obliterans Syndrome (CLAD-BOS) Post Lung Transplantation
Lead Sponsor:
Zambon SpA
Conditions:
Bronchiolitis Obliterans Syndrome Due to and After Lung Transplantation (Disorder)
Eligibility:
All Genders
18+ years
Brief Summary
The aim of this study is to describe the forced expiratory volume in 1 second (FEV1) decline and natural disease evolution in patients affected by CLAD-BOS after lung transplantation and receiving an ...
Detailed Description
This is a retrospective, multinational, multicenter chart review study of adult patients with clinically diagnosed CLAD-BOS after lung transplantation. All data will be retrospectively collected from ...
Eligibility Criteria
Inclusion
- Adult patients ≥ 18 years of age on the date of CLAD-BOS diagnosis
- Patients with a CLAD-BOS clinician diagnosis from as early as 01 January 2013
- Patients with CLAD-BOS clinician diagnosis made at least 12 months after lung transplant
- Patients received at least basic maintenance regimen of immunosuppressive agents including tacrolimus, a second agent such as but not limited to mycophenolate mofetil or azathioprine (or other anti-proliferative agent), and a systemic corticosteroid such as prednisone as third agent for at least 1 month before the index date. As long as the basic maintenance regimen is maintained for the abovementioned period, patients will still be considered eligible for the study even if they are receiving other immunosuppressive agents in addition to the basic maintenance regimen.
Exclusion
- Patients with severe concomitant disease at the time of index date, which according to physician's judgment, can interfere with CLAD-BOS progression and mortality (e.g., malignancies, severe chronic diseases)
- Patients who have been exposed to any investigational medical products in the 4 weeks prior to index date or during the post-diagnosis period
- Patients with confirmed other CLAD phenotype (e.g., restrictive allograft syndrome) according to physician's judgment.
Key Trial Info
Start Date :
June 27 2024
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
April 2 2025
Estimated Enrollment :
284 Patients enrolled
Trial Details
Trial ID
NCT06503770
Start Date
June 27 2024
End Date
April 2 2025
Last Update
May 20 2025
Active Locations (6)
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1
Cleveland Clinic Main Campus
Cleveland, Ohio, United States, 44195
2
Baylor Scott and White Health Advanced Lung Disease Specialists
Columbus, Ohio, United States, 43210
3
Baylor Scott and White Health Advanced Lung Disease Specialists
Dallas, Texas, United States, 75246
4
Universitaire Ziekenhuizen Leuven (UZ Leuven) Campus Gasthuisberg
Leuven, Leuven, Belgium, 3000