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Extension Study of Arikayce in Cystic Fibrosis (CF) Patients With Chronic Pseudomonas Aeruginosa Infection

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ClinicalTrials.gov Identifier: NCT01316276
Recruitment Status : Completed
First Posted : March 16, 2011
Last Update Posted : October 3, 2016
Sponsor:
Information provided by (Responsible Party):
Insmed Incorporated

March 14, 2011
March 16, 2011
October 3, 2016
October 2012
July 2015   (Final data collection date for primary outcome measure)
  • Incidence of treatment emergent adverse events [ Time Frame: Day 337 - first extension period ]
    Treatment emergent adverse events including serious adverse events and adverse events leading to permanent discontinuation of study drug
  • Relative change in FEV1 [liters] and FEV1 % predicted [ Time Frame: Day 337 - first extension period ]
  • Acute tolerability as measured by PFT changes pre- to post-dose [ Time Frame: Day 337 - first extension period ]
Same as current
Complete list of historical versions of study NCT01316276 on ClinicalTrials.gov Archive Site
  • Time to first protocol defined pulmonary exacerbation and proportion of subjects experiencing a protocol defined pulmonary exacerbation [ Time Frame: Day 337 - first extension period ]
  • Time to first antipseudomonal antibiotic treatment for protocol defined pulmonary exacerbation, proportion of subjects initiating treatment and number of days of treatment [ Time Frame: Day 337 - first extension period ]
  • Shift in minimum inhibitory concentration for Pseudomonas aeruginosa throughout the study [ Time Frame: Day 337 - first extension period ]
  • Evaluation of emergent pathogens [ Time Frame: Day 337 - first extension period ]
Same as current
Not Provided
Not Provided
 
Extension Study of Arikayce in Cystic Fibrosis (CF) Patients With Chronic Pseudomonas Aeruginosa Infection
Long Term Safety and Tolerability of Open-Label Liposomal Amikacin for Inhalation (Arikayce™) in Cystic Fibrosis Patients With Chronic Infection Due to Pseudomonas Aeruginosa
The purpose of this study is to evaluate the long term safety and tolerability of Arikayce in Cystic Fibrosis patients. This long-term, open-label, multi-cycle extension study will enroll subjects who have successfully completed study TR02-108, were compliant with the study protocol, and did not meet any of the listed study discontinuation criteria. The safety and tolerability of Arikayce will be evaluated for up to approximately 2 years.
Not Provided
Interventional
Phase 3
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Cystic Fibrosis
Drug: Liposomal amikacin for inhalation
  • Liposomal amikacin for inhalation is provided as a sterile aqueous liposomal dispersion for inhalation via nebulization.
  • 590 mg of liposomal amikacin for inhalation is administered once daily using the PARI Investigational eFlow® Nebulizer.
  • Administration time is approximately 13 minutes.
  • Liposomal amikacin for inhalation will be administered in two consecutive extension periods, each consisting of 6 cycles for a total of 12 cycles. Each cycle consists of 28 days on-treatment followed by 28 days off-treatment.
Experimental: Arikayce
Intervention: Drug: Liposomal amikacin for inhalation
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
206
250
Not Provided
July 2015   (Final data collection date for primary outcome measure)

Key Inclusion Criteria:

  • Written informed consent or assent
  • Subject has completed study TR02-108, and has been compliant with the study protocol
  • Women of childbearing potential must agree to use reliable methods of contraception for the duration of the study

Key Exclusion Criteria:

  • Subject met any of the listed criteria for study drug discontinuation in protocol TR02-108.
  • Abnormal laboratory assessments including LFT (≥ 3× ULN), serum creatinine (> 2× ULN) and ANC (< 1000).
  • Psychotic, addictive or other disorder limiting the ability to provide informed consent or to comply with study requirements.
  • History of alcohol, medication or illicit drug abuse within the 6 months prior to consent.
  • Smoking tobacco or any substance within 6 months prior to consent or anticipated inability to refrain from smoking throughout the study
Sexes Eligible for Study: All
6 Years and older   (Child, Adult, Older Adult)
No
Contact information is only displayed when the study is recruiting subjects
Austria,   Belgium,   Bulgaria,   Canada,   Denmark,   France,   Germany,   Greece,   Hungary,   Ireland,   Italy,   Netherlands,   Poland,   Serbia,   Slovakia,   Spain,   United Kingdom
 
 
NCT01316276
TR02-110
Yes
Not Provided
Not Provided
Insmed Incorporated
Insmed Incorporated
Not Provided
Study Director: Gina Eagle, MD Insmed Incorporated
Insmed Incorporated
September 2016

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