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NCT04039347 · ClinicalTrials.gov registry record · Phase 3
Extension Trial on Efficacy / Safety of L-CsA + SoC in Treating BOS in Post Single or Double Lung Transplant (BOSTON-3)
A Phase 3 study of Bronchiolitis Obliterans and Bronchiolitis Obliterans Syndrome, sponsored by Zambon SpA.
- Active
- Registry status
- Phase 3
- Development phase
- 262
- Enrollment target
- 20
- Study locations
NCT04039347 is a Phase 3 study of Bronchiolitis Obliterans and Bronchiolitis Obliterans Syndrome that is active but no longer recruiting, run by Zambon SpA. The registered enrollment target is 262 participants, below the 380-participant average among 9 other Bronchiolitis Obliterans trials with a reported enrollment target (31% lower). The trial reports 20 study locations across 12 states.
The verdict
NCT04039347, a Phase 3 study of Bronchiolitis Obliterans and Bronchiolitis Obliterans Syndrome, is active but no longer recruiting, sponsored by Zambon SpA.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 3
- Development phase
- 262 participants
- Enrollment target
- 20
- Study locations
Study Summary
The objective of the trial is to assess the long-term safety and efficacy of L-CsA plus Standard of Care (SoC) in the treatment of BOS in single (SLT) and double lung transplant (DLT) recipients.
Conditions Studied
Interventions
- DRUG Liposomal Cyclosporine A 5 mg
- DRUG Liposomal Cyclosporine A 10 mg
Study Locations (20)
Texas
- Baylor University Medical Center - Dallas
- University of Texas Southwestern Medical Center - Dallas
- Baylor College of Medicine - Houston
- Houston Methodist Hospital - Houston
California
- David Geffen School of Medicine at UCLA - Los Angeles
- UCSF - San Francisco
- UCSF Center for Advanced Lung Disease - Stanford
Maryland
- University of Maryland - Baltimore
- Johns Hopkins University Hospital - Baltimore
Ohio
- Cleveland Clinic - Cleveland
- OSU Wexner Medical Center - Columbus
Pennsylvania
- Temple University Hospital - Philadelphia
- University of Pittsburgh Medical Center - Pittsburgh
Arizona
- Banner - University Medical Center - Phoenix
Florida
- University of Florida Dept of Pulmonary Medicine - Gainesville
Indiana
- Indiana University - Indianapolis
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 262 participants |
| Start Date | 2020-03-12 |
| Est. Completion | 2025-12 |
| Phase | Phase 3 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04039347
The ClinicalTrials.gov registry entry for NCT04039347 describes a study currently listed as active not recruiting, categorized as Phase 3. The registered enrollment target is 262 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 380-participant average among 9 other Bronchiolitis Obliterans trials with a reported enrollment target (31% lower). The listed sponsor is Zambon SpA, which has 5 total studies on file at ClinicalTrials.gov.
The record links to 3 conditions, with Bronchiolitis Obliterans appearing as the primary indexed condition, and to 2 interventions - of which Liposomal Cyclosporine A 5 mg is the first listed.
NCT04039347 reports 20 study locations spanning 12 distinct geographic areas - top geographies include Texas, California, Maryland.
Frequently Asked Questions
What is clinical trial NCT04039347 about?
NCT04039347 is a clinical study titled "Extension Trial on Efficacy / Safety of L-CsA + SoC in Treating BOS in Post Single or Double Lung Transplant (BOSTON-3)". The objective of the trial is to assess the long-term safety and efficacy of L-CsA plus Standard of Care (SoC) in the treatment of BOS in single (SLT) and double lung transplant (DLT) recipients.
What is the current status of trial NCT04039347?
This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 262 participants. The study started on 2020-03-12. Estimated completion is 2025-12.
What conditions does trial NCT04039347 study?
This clinical trial studies the following conditions: Bronchiolitis Obliterans, Bronchiolitis Obliterans Syndrome, Obliterative Bronchiolitis.
What interventions are being tested in trial NCT04039347?
The interventions under investigation include: Liposomal Cyclosporine A 5 mg (DRUG), Liposomal Cyclosporine A 10 mg (DRUG).
Who is sponsoring clinical trial NCT04039347?
This trial is sponsored by Zambon SpA, which has 5 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04039347 being conducted?
This trial has 20 study locations across Arizona, California, Florida, Indiana, Kentucky. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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