Long-term Safety Follow-up Study in the Prevention of Bronchiolitis Obliterans Syndrome (BOS)
This study is currently recruiting participants.
Verified February 2012 by Pari Pharma GmbH
Sponsor:
Pari Pharma GmbH
Information provided by (Responsible Party):
Pari Pharma GmbH
ClinicalTrials.gov Identifier:
NCT01439958
First received: September 22, 2011
Last updated: February 21, 2012
Last verified: February 2012
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Bronchiolitis Obliterans |
Drug: Inhalation |
Phase 3 |
| Study Type: | Interventional |
| 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 |
Resource links provided by NLM:
Further study details as provided by Pari Pharma GmbH:
Primary Outcome Measures:
- 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.
Secondary Outcome Measures:
- 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
| Estimated Enrollment: | 75 |
| 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) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: L-CsA
Twice daily inhalation of L-CsA
|
Drug: Inhalation
Twice daily inhalation for a maximum of three years.
Other Name: aerosolized liposomal CsA
|
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.
Determination of long-term safety and efficacy outcome over a maximum of three years will be assessed.
Eligibility| Ages Eligible for Study: | 18 Years to 80 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- 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 Criteria:
- 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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01439958
Contacts
| Contact: Oliver Denk, PhD | +49 89 742846 ext 59 | o.denk@pari.de |
| Contact: Stefanie Prante | +49 89 742846 ext 830 | s.prante@pari.de |
Locations
| Germany | |
| PARI Pharma GmbH | Recruiting |
| Graefelfing, Germany, 82166 | |
| Contact: Stefanie Prante +49 89 742846 ext 830 s.prante@pari.de | |
Sponsors and Collaborators
Pari Pharma GmbH
Investigators
| Principal Investigator: | Claus Neurohr, MD | Ludwig-Maximilians - University of Munich |
More Information
No publications provided
| Responsible Party: | Pari Pharma GmbH |
| ClinicalTrials.gov Identifier: | NCT01439958 History of Changes |
| Other Study ID Numbers: | 12011.203, 2011-004304-38 |
| Study First Received: | September 22, 2011 |
| Last Updated: | February 21, 2012 |
| Health Authority: | Germany: Federal Institute for Drugs and Medical Devices Belgium: Federal Agency for Medicinal Products and Health Products Austria: Agency for Health and Food Safety Canada: Health Canada Denmark: Danish Medicines Agency France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis) Spain: Spanish Agency of Medicines United Kingdom: Medicines and Healthcare Products Regulatory Agency |
Keywords provided by Pari Pharma GmbH:
|
Inhalation Lung Transplantation Cyclosporine |
Additional relevant MeSH terms:
|
Bronchiolitis Bronchiolitis Obliterans Bronchitis Bronchial Diseases |
Respiratory Tract Diseases Lung Diseases, Obstructive Lung Diseases Respiratory Tract Infections |
ClinicalTrials.gov processed this record on June 18, 2013