Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at UCLA UCSF
Dates
study started
completion around
Principal Investigator
by Stephen Weigt (ucla)
Headshot of Stephen Weigt
Stephen Weigt

Description

Summary

The objective of the trial is to assess efficacy and safety of add-on aerosolized liposomal cyclosporine A (L-CsA) to Standard of Care (SoC) therapy as compared to SoC therapy alone in the treatment of Bronchiolitis obliterans syndrome (BOS) in double lung transplant recipients.

Official Title

A Phase III Clinical Trial to Demonstrate Efficacy / Safety of Liposomal Cyclosporine A + Standard of Care (SoC) vs SoC Alone in Treating Chronic Lung Allograft Dysfunction / Bronchiolitis Obliterans in Patients Post Double Lung Transplant

Details

Keywords

Bronchiolitis Obliterans, Chronic Rejection of Lung Transplant, Lung Transplant Rejection, Lung Transplant; Complications, Lung Transplant Failure and Rejection, Chronic Lung Allograft Dysfunction, Bronchiolitis, Bronchiolitis Obliterans Syndrome, Cyclosporine, Cyclosporins, Liposomal Cyclosporine A

Eligibility

Locations

  • UCLA Medical Center
    Los Angeles California 90095 United States
  • UC San Francisco
    San Francisco California 94143 United States
  • Stanford University Hospital
    Palo Alto California 94305 United States

Lead Scientist at University of California Health

  • Stephen Weigt (ucla)
    Clinical and translational research in lung transplantation and interstitial lung disease.

Details

Status
in progress, not accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Zambon SpA
ID
NCT03656926
Phase
Phase 3 research study
Study Type
Interventional
Participants
About 220 people participating
Last Updated