Extension Study of Liposomal Amikacin for Inhalation in Cystic Fibrosis (CF) Patients With Chronic Pseudomonas Aeruginosa (Pa) Infection

• Status: Completed
• Trial end date: 2015-07-16
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to evaluate the long term safety and tolerability of Liposomal Amikacin for Inhalation (LAI) 590 mg once daily (QD) in Cystic Fibrosis patients with chronic infection due to pseudomonas aeruginosa. This long-term, open-label, multi-cycle extension study enrolled subjects who had 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 LAI were evaluated for up to approximately 2 years.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Insmed Incorporated
• Treatments: Amikacin

Criteria

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× upper limit of normal [ULN]), serum creatinine (> 2× ULN) and absolute neutrophil count [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