Status:
TERMINATED
Long-term Safety Follow-up Study in the Prevention of Bronchiolitis Obliterans Syndrome (BOS)
Lead Sponsor:
Pari Pharma GmbH
Conditions:
Bronchiolitis Obliterans
Eligibility:
All Genders
18-80 years
Phase:
PHASE3
Brief Summary
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 phas...
Detailed Description
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. Determinati...
Eligibility Criteria
Inclusion
- Patient has completed the L-CsA clinical trial 12011.201
- Patient is capable of understanding the purpose and risks of the follow-up study, has been fully informed and has given written informed consent to participate in the study
- Female patients of child bearing potential must test negative on standard urine pregnancy test prior to continuation and must agree to practice effective birth control during the study
- Estimated life expectancy \> 6 months
- Capable of self-administration of medications
- Patient has stable creatinine levels
Exclusion
- Patients with ongoing irreversible L-CsA related serious adverse events
- Patients with known hypersensitivity for ciclosporin A
- Patient intends to participate in another IMP clinical trial other than listed in the inclusion criteria
- Patient receives mechanical ventilation
- Patients underwent pulmonary re-transplantation
- Patient is a pregnant or breast-feeding woman
- Patient is unlikely to comply with visits, inhalation procedures or spirometric measurements scheduled in the protocol
- Patient receives any systemic or topical Rosuvastatin
- Patient has been previously enrolled in this study
- Patient with malignancy diagnosed during study 12011.201 (with the exception of skin cancer)
- Documented respiratory infections unless on appropriate antimicrobial therapy with evidence of clinical response
- Patient is not eligible to continue IMP inhalation according to the Investigator's discretion
Key Trial Info
Start Date :
February 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2014
Estimated Enrollment :
14 Patients enrolled
Trial Details
Trial ID
NCT01439958
Start Date
February 1 2012
End Date
December 1 2014
Last Update
April 14 2015
Active Locations (1)
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1
PARI Pharma GmbH
Gräfelfing, Germany, 82166