Trial Profile
A phase II, randomised, double-blind, placebo controlled, parallel group, dose-finding clinical trial to investigate the efficacy and safety of 10 and 20 mg/day aerosolised liposomal cyclosporin A (L-CsA) versus aerosolised placebo in the prevention of bronchiolitis obliterans (BO) in lung transplant (LT) patients
Status:
Discontinued
Phase of Trial:
Phase III
Latest Information Update: 20 Oct 2021
Price :
$35
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At a glance
- Drugs Ciclosporin (Primary)
- Indications Bronchiolitis obliterans
- Focus Therapeutic Use
- Acronyms L-CsA-LT
- Sponsors PARI Pharma GmbH
- 29 Sep 2021 Protocol of study has been amended to change study from phase 2 to A Phase 3 pivotal study concept, including sample size increment from 60 to 180 patients, omission of the low-dose L-CsA-i treatment arm, and 1:1 treatment randomization to high-dose L-CsA-i or placebo
- 29 Sep 2021 Primary endpoint has not been met. (The primary objective is to compare cumulative BOS-free survival of patients recieving L-CsA or placebo.), as per Results published in the American Journal of Transplantation
- 29 Sep 2021 Results published in the American Journal of Transplantation