Clincosm LogoSign in Get a demo

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

Sponsor
Pari Pharma GmbH (Industry)
Overall Status
Terminated
CT.gov ID
NCT01439958
Collaborator
(none)
14
Enrollment
1
Location
1
Arm
34
Duration (Months)
0.4
Patients Per Site Per Month

Study Details

Study Description

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 phase II/III L-CsA clinical trial 12011.201.

Condition or Disease Intervention/Treatment Phase
Phase 3

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
14 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (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
Study Start Date :
Feb 1, 2012
Actual Primary Completion Date :
Jul 1, 2013
Actual Study Completion Date :
Dec 1, 2014

Arms and Interventions

Arm Intervention/Treatment
Experimental: L-CsA

Twice daily inhalation of L-CsA

Drug: Inhalation
Twice daily inhalation for a maximum of three years.
Other Names:
  • aerosolized liposomal CsA

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Long-term safety of L-CsA in prevention of bronchiolitis obliterans syndrome (BOS) [3 years]

      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

    1. Long-term efficacy outcome over a maximum of three years of patients previously enrolled in phase II/III L-CsA clinical trial 12011.201 [3 years]

      Efficacy will be assessed mainly for the following efficacy endpoints: BOS-free survival Incidence of BOS Pulmonary function

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 80 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 PARI Pharma GmbH Graefelfing Germany 82166

    Sponsors and Collaborators

    • Pari Pharma GmbH

    Investigators

    • Principal Investigator: Claus Neurohr, MD, Ludwig-Maximilians - University of Munich

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Pari Pharma GmbH
    ClinicalTrials.gov Identifier:
    NCT01439958
    Other Study ID Numbers:
    • 12011.203
    • 2011-004304-38
    First Posted:
    Sep 23, 2011
    Last Update Posted:
    Apr 14, 2015
    Last Verified:
    Apr 1, 2015
    Keywords provided by Pari Pharma GmbH
    Inhalation
    Lung Transplantation
    Cyclosporine
    Additional relevant MeSH terms:
    Bronchiolitis
    Bronchiolitis Obliterans

    Study Results

    No Results Posted as of Apr 14, 2015