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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT02628600




Registration number
NCT02628600
Ethics application status
Date submitted
8/12/2015
Date registered
11/12/2015
Date last updated
29/09/2016

Titles & IDs
Public title
Open-label Safety Extension Study Assessing Safety and Tolerability of LAI in Patients Who Participated in Study INS-212
Scientific title
Secondary ID [1] 0 0
2015-003170-33
Secondary ID [2] 0 0
INS-312
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
NTM Lung Infection Due to MAC 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Liposomal Amikacin for Inhalation

Experimental: LAI -


Treatment: Drugs: Liposomal Amikacin for Inhalation


Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Frequency of treatment-emergent adverse events (TEAEs)
Timepoint [1] 0 0
13 months
Secondary outcome [1] 0 0
Proportion of subjects achieving culture conversion at Month 6
Timepoint [1] 0 0
6 months

Eligibility
Key inclusion criteria
Key

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
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. achieved culture conversion without relapse or recurrence in the Study INS-212 study by
Month 6

Study design
Purpose of the study
Treatment
Allocation to intervention
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 3
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Unknown status
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
- Chermside
Recruitment hospital [2] 0 0
- Clayton
Recruitment hospital [3] 0 0
- Concord
Recruitment hospital [4] 0 0
- Greenslopes
Recruitment hospital [5] 0 0
- Woolloongabba
Recruitment postcode(s) [1] 0 0
- Chermside
Recruitment postcode(s) [2] 0 0
- Clayton
Recruitment postcode(s) [3] 0 0
- Concord
Recruitment postcode(s) [4] 0 0
- Greenslopes
Recruitment postcode(s) [5] 0 0
- Woolloongabba
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
Florida
Country [3] 0 0
United States of America
State/province [3] 0 0
Georgia
Country [4] 0 0
United States of America
State/province [4] 0 0
Illinois
Country [5] 0 0
United States of America
State/province [5] 0 0
Maryland
Country [6] 0 0
United States of America
State/province [6] 0 0
Minnesota
Country [7] 0 0
United States of America
State/province [7] 0 0
New York
Country [8] 0 0
United States of America
State/province [8] 0 0
North Carolina
Country [9] 0 0
United States of America
State/province [9] 0 0
Oregon
Country [10] 0 0
United States of America
State/province [10] 0 0
Pennsylvania
Country [11] 0 0
United States of America
State/province [11] 0 0
South Carolina
Country [12] 0 0
United States of America
State/province [12] 0 0
Texas
Country [13] 0 0
Canada
State/province [13] 0 0
Calgary
Country [14] 0 0
Canada
State/province [14] 0 0
Kelowna
Country [15] 0 0
Canada
State/province [15] 0 0
Windsor
Country [16] 0 0
Germany
State/province [16] 0 0
Borstel
Country [17] 0 0
Germany
State/province [17] 0 0
Hannover
Country [18] 0 0
Japan
State/province [18] 0 0
Aichi
Country [19] 0 0
Japan
State/province [19] 0 0
Nagano
Country [20] 0 0
Japan
State/province [20] 0 0
Osaka
Country [21] 0 0
Japan
State/province [21] 0 0
Tokyo
Country [22] 0 0
Netherlands
State/province [22] 0 0
Groesbeek
Country [23] 0 0
New Zealand
State/province [23] 0 0
Wellington
Country [24] 0 0
Spain
State/province [24] 0 0
Madrid
Country [25] 0 0
United Kingdom
State/province [25] 0 0
Chertsey
Country [26] 0 0
United Kingdom
State/province [26] 0 0
Edinburgh
Country [27] 0 0
United Kingdom
State/province [27] 0 0
Lancaster
Country [28] 0 0
United Kingdom
State/province [28] 0 0
Liverpool
Country [29] 0 0
United Kingdom
State/province [29] 0 0
London

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Insmed Incorporated
Address
Country

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/show/NCT02628600
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Gina Eagle, MD
Address 0 0
Insmed Incorporated
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
For IPD and results data, please see https://clinicaltrials.gov/show/NCT02628600