Modern Trials

Clinical Trials

NCT Id	NCT04107675
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)	CHU Hôpital Sud, Amiens, France Centre Hospitalier Universitaire d'Angers, Angers, France Centre Hospitalier Universitaire Grenoble Alpes, La Tronche, France Centre Hospitalier Régional Universitaire de Lille, Lille, France CHU de Nancy, Hopital Brabois, Nancy, France CHU de Nantes - Hotel-Dieu, Nantes, France Hopital Saint Louis, Paris, France CHU Hopitaux de Bordeaux, Pessac, France Centre Henri Becquerel, Rouen, France St.-Johannes-Hospital, Dortmund, Germany Universitätsklinikum Carl Gustav Carus, Dresden, Germany Universitätsklinikum Köln, Köln, Germany Universitätsklinikum Münster, Münster, Germany Hospital Clinic i Provincial, Barcelona, Spain Hospital de la Santa Creu, Barcelona, Spain Hospital Universitario Ramón y Cajal, Madrid, Spain Hospital Clinico Universitario de Valencia, Valencia, Spain Hospital Universitari i Politècnic La Fe, Valencia, Spain
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.