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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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28 April 2015 |
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Main ID: |
NCT01439958 |
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Date of registration:
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22/09/2011 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Long-term Safety Follow-up Study in the Prevention of Bronchiolitis Obliterans Syndrome (BOS)
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Scientific title:
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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 |
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Date of first enrolment:
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February 2012 |
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Target sample size:
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14 |
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Recruitment status: |
Terminated |
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URL:
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http://clinicaltrials.gov/show/NCT01439958 |
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Study type:
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Interventional |
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Study design:
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Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention
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Phase:
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Phase 3
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Countries of recruitment
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Germany
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Contacts
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Name:
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Claus Neurohr, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Ludwig-Maximilians - University of Munich |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
1. Patient has completed the L-CsA clinical trial 12011.201
2. 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
3. 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
4. Estimated life expectancy > 6 months
5. Capable of self-administration of medications
6. Patient has stable creatinine levels
Exclusion Criteria:
1. Patients with ongoing irreversible L-CsA related serious adverse events
2. Patients with known hypersensitivity for ciclosporin A
3. Patient intends to participate in another IMP clinical trial other than listed in the
inclusion criteria
4. Patient receives mechanical ventilation
5. Patients underwent pulmonary re-transplantation
6. Patient is a pregnant or breast-feeding woman
7. Patient is unlikely to comply with visits, inhalation procedures or spirometric
measurements scheduled in the protocol
8. Patient receives any systemic or topical Rosuvastatin
9. Patient has been previously enrolled in this study
10. Patient with malignancy diagnosed during study 12011.201 (with the exception of skin
cancer)
11. Documented respiratory infections unless on appropriate antimicrobial therapy with
evidence of clinical response
12. Patient is not eligible to continue IMP inhalation according to the Investigator's
discretion
Age minimum:
18 Years
Age maximum:
80 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Bronchiolitis Obliterans
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Intervention(s)
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Drug: Inhalation
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Primary Outcome(s)
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Long-term safety of L-CsA in prevention of bronchiolitis obliterans syndrome (BOS)
[Time Frame: 3 years]
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Secondary Outcome(s)
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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]
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Secondary ID(s)
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12011.203
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2011-004304-38
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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