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Open-label Safety Extension Study Assessing Safety and Tolerability of LAI in Patients Who Participated in Study INS-212

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ClinicalTrials.gov Identifier: NCT02628600
Recruitment Status : Unknown
Verified September 2016 by Insmed Incorporated.
Recruitment status was:  Enrolling by invitation
First Posted : December 11, 2015
Last Update Posted : September 29, 2016
Sponsor:
Information provided by (Responsible Party):
Insmed Incorporated

Brief Summary:
This open-label safety extension study will assess the safety and tolerability of once daily dosing of 590 mg Liposomal Amikacin for Inhalation (LAI) added to a multi-drug regimen in subjects with non-tuberculous mycobacterium (NTM) lung infections due to Mycobacterium avium complex (MAC) who are refractory to therapy in Study INS-212.

Condition or disease Intervention/treatment Phase
NTM Lung Infection Due to MAC Drug: Liposomal Amikacin for Inhalation Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Study Start Date : December 2015
Estimated Primary Completion Date : August 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: LAI Drug: Liposomal Amikacin for Inhalation



Primary Outcome Measures :
  1. Frequency of treatment-emergent adverse events (TEAEs) [ Time Frame: 13 months ]

Secondary Outcome Measures :
  1. Proportion of subjects achieving culture conversion at Month 6 [ Time Frame: 6 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Key Inclusion Criteria:

  1. have successfully completed the Month 6 and End of Treatment visits in Study INS-212
  2. have not achieved the INS-212 protocol definition of culture conversion by Month 6 in Study INS-212 OR have experienced a relapse or recurrence by Month 6 in Study INS-212.

Key Exclusion Criteria:

1. achieved culture conversion without relapse or recurrence in the Study INS-212 study by Month 6


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02628600


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Sponsors and Collaborators
Insmed Incorporated
Investigators
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Study Director: Gina Eagle, MD Insmed Incorporated

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Responsible Party: Insmed Incorporated
ClinicalTrials.gov Identifier: NCT02628600     History of Changes
Other Study ID Numbers: INS-312
2015-003170-33 ( EudraCT Number )
First Posted: December 11, 2015    Key Record Dates
Last Update Posted: September 29, 2016
Last Verified: September 2016
Additional relevant MeSH terms:
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Amikacin
Anti-Bacterial Agents
Anti-Infective Agents