NCT Id | NCT04107675 |
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Title | A Safety Study of Liposomal Cyclosporine A to Treat Bronchiolitis Obliterans Syndrome Following Allogeneic Hematopoietic Stem Cell Transplant |
Condition | Bronchiolitis Obliterans |
StudyType | Interventional |
Organization | Zambon SpA |
Sponsor/Collaborators | Zambon SpA |
Status | Recruiting |
Gender | All |
AgeGroup | Adult Older Adult |
Location (with distance) |
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Description | This is a Phase II prospective, multi-center, single-blind, randomized clinical trial of safety in the treatment of BOS 1 in adult recipients of an allogeneic hematopoetic stem cell transplant. Twenty-four patients are planned for enrollment. The clinical trial will be conducted in approximately 20 centers in Germany, France, and Spain. Patients will be randomly allocated 1:1:1 to receive either L-CsA (10 mg bid or 5 mg bid) plus Standard of Care, or liposomal placebo plus Standard of Care. Investigational Medicinal Product will be administered for up to 12 weeks. |