Overview

A Safety Study of Liposomal Cyclosporine A to Treat Bronchiolitis Obliterans Syndrome Following Allogeneic Hematopoietic Stem Cell Transplant

Status:
Recruiting

Trial end date:
2022-05-01

Target enrollment:

Participant gender:

Summary

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.

Phase:

Phase 2

Details

Lead Sponsor:

Breath Therapeutics Inc.
Zambon SpA

Treatments:

Cyclosporine
Cyclosporins