Long-term Safety Follow-up Study in the Prevention of Bronchiolitis Obliterans Syndrome (BOS)
The purpose of this study is to evaluate long-term safety of L-CsA in prevention of bronchiolitis obliterans syndrome (BOS) following lung transplantation (LTx) in patients previously enrolled in phase II/III L-CsA clinical trial 12011.201.
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
|Official Title:||A Long-term Safety Follow-up Study of L-CsA Therapy for Patients Who Participated in Study 12011.201 and Volunteered to Continue or to Cross-over to L-CsA Inhalation Therapy|
- Long-term safety of L-CsA in prevention of bronchiolitis obliterans syndrome (BOS) [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]Safety will be assesses by the numbers of treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) and overall rate of mortality.
- Long-term efficacy outcome over a maximum of three years of patients previously enrolled in phase II/III L-CsA clinical trial 12011.201 [ Time Frame: 3 years ] [ Designated as safety issue: No ]
Efficacy will be assessed mainly for the following efficacy endpoints:
- BOS-free survival
- Incidence of BOS
- Pulmonary function
|Study Start Date:||February 2012|
|Estimated Study Completion Date:||February 2016|
|Estimated Primary Completion Date:||February 2016 (Final data collection date for primary outcome measure)|
Twice daily inhalation of L-CsA
Twice daily inhalation for a maximum of three years.
Other Name: aerosolized liposomal CsA
This is an uncontrolled extension study open only to patients who completed the Phase II/III core study 12011.201 and volunteered to continue or to cross-over to L-CsA inhalation therapy.
Determination of long-term safety and efficacy outcome over a maximum of three years will be assessed.
|Contact: Oliver Denk, PhD||+49 89 742846 ext email@example.com|
|Contact: Stefanie Prante||+49 89 742846 ext firstname.lastname@example.org|
|PARI Pharma GmbH||Recruiting|
|Graefelfing, Germany, 82166|
|Contact: Stefanie Prante +49 89 742846 ext 830 email@example.com|
|Principal Investigator:||Claus Neurohr, MD||Ludwig-Maximilians - University of Munich|