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Long-term Safety Follow-up Study in the Prevention of Bronchiolitis Obliterans Syndrome (BOS)

This study has been terminated.
(Core study 12011.201 was terminated.)
Sponsor:
Information provided by (Responsible Party):
Pari Pharma GmbH
ClinicalTrials.gov Identifier:
NCT01439958
First received: September 22, 2011
Last updated: September 3, 2013
Last verified: September 2013

September 22, 2011
September 3, 2013
February 2012
July 2013   (final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT01439958 on ClinicalTrials.gov Archive Site
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
Same as current
Not Provided
Not Provided
 
Long-term Safety Follow-up Study in the Prevention of Bronchiolitis Obliterans Syndrome (BOS)
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

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.

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.

Interventional
Phase 3
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
Bronchiolitis Obliterans
Drug: Inhalation
Twice daily inhalation for a maximum of three years.
Other Name: aerosolized liposomal CsA
Experimental: L-CsA
Twice daily inhalation of L-CsA
Intervention: Drug: Inhalation
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
14
December 2013
July 2013   (final data collection date for primary outcome measure)

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
Both
18 Years to 80 Years
No
Contact information is only displayed when the study is recruiting subjects
Germany
 
NCT01439958
12011.203, 2011-004304-38
No
Pari Pharma GmbH
Pari Pharma GmbH
Not Provided
Principal Investigator: Claus Neurohr, MD Ludwig-Maximilians - University of Munich
Pari Pharma GmbH
September 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP