Status:
ACTIVE_NOT_RECRUITING
Extension Trial on Efficacy / Safety of L-CsA + SoC in Treating BOS in Post Single or Double Lung Transplant (BOSTON-3)
Lead Sponsor:
Zambon SpA
Conditions:
Bronchiolitis Obliterans
Obliterative Bronchiolitis
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief 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.
Detailed Description
This is a Phase III, multicenter, open-label, extension clinical trial of L-CsA for the treatment of BOS. Enrollment will be limited to patients who have completed 48 weeks participation in either th...
Eligibility Criteria
Inclusion
- Patients who have completed all visits through the End of Treatment Visit in either BOSTON-1 or BOSTON-2, did not withdraw informed consent, and did not prematurely terminate study drug administration.
- Patients should be on a three-drug maintenance regimen of immunosuppressive agents including tacrolimus or another CNI, a second agent such as but not limited to MMF or azathioprine, and a systemic corticosteroid such as prednisone.
- Patients capable of understanding the purposes and risks of the clinical trial, who have given written informed consent and agree to comply with the clinical trial requirements/visit schedules, and who are capable of aerosol inhalation.
- Women of childbearing potential must have a negative serum pregnancy test within 7 days prior to Visit 1 and must agree to use one of the methods of contraception listed in Appendix II through their End of Study Visit.
Exclusion
- Known hypersensitivity to L-CsA or to cyclosporine A.
- Patients who experienced an AE related to study drug that led to permanent study drug discontinuation in BOSTON-1 or BOSTON-2.
- Patients with new onset of malignancy while participating in BOSTON-1 or BOSTON-2, including post-transplant lymphoproliferative disorder, with the exception of treated, localized basal and squamous cell carcinomas.
- Pregnant women or women who are unwilling to use appropriate birth control to avoid pregnancy through their End of Study Visit.
- Women who are currently breastfeeding.
- Receipt of an investigational drug, other than L-CsA, as part of a clinical trial within 4 weeks prior to Visit 1. This is defined as any treatment that is implemented under an Investigational New Drug (IND) or compassionate use.
- Patients who are currently participating in an interventional clinical trial, other than BOSTON-1 or BOSTON-2.
- Psychiatric disorders or altered mental status precluding understanding of the informed consent process and/or completion of the necessary procedures.
- Any co-existing medical condition that in the Investigator's judgment will substantially increase the risk associated with the patient's participation in the clinical trial.
Key Trial Info
Start Date :
March 12 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2025
Estimated Enrollment :
262 Patients enrolled
Trial Details
Trial ID
NCT04039347
Start Date
March 12 2020
End Date
December 1 2025
Last Update
January 27 2025
Active Locations (37)
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1
Banner - University Medical Center
Phoenix, Arizona, United States, 85006
2
David Geffen School of Medicine at UCLA
Los Angeles, California, United States, 90095
3
UCSF
San Francisco, California, United States, 94143
4
UCSF Center for Advanced Lung Disease
Stanford, California, United States, 94305