Clinical Trials

NCT IdNCT04107675
TitleA Safety Study of Liposomal Cyclosporine A to Treat Bronchiolitis Obliterans Syndrome Following Allogeneic Hematopoietic Stem Cell Transplant
ConditionBronchiolitis Obliterans
StudyTypeInterventional
OrganizationBreath Therapeutics Inc.
Sponsor/CollaboratorsBreath Therapeutics Inc.
StatusRecruiting
GenderAll
AgeGroupAdult
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 Leipzig, Leipzig, 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
DescriptionThis 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.