Arikayce™ (DrugBank: -)
1 disease| 告示番号 | 疾患名（ページ内リンク） | 臨床試験数 |
|---|---|---|
| 299 | 嚢胞性線維症 | 3 |
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | NCT01315678 (ClinicalTrials.gov) | February 29, 2012 | 14/3/2011 | Study to Evaluate Arikayce™ in CF Patients With Chronic Pseudomonas Aeruginosa Infections | Randomized, Open-Label, Active-Controlled, Multicenter Study to Assess the Efficacy, Safety and Tolerability of Arikayce™ in Cystic Fibrosis Patients With Chronic Infection Due to Pseudomonas Aeruginosa | Pseudomonas Aeruginosa Infection | Drug: Liposomal amikacin for inhalation (Arikayce™) using the PARI Investigational eFlow® Nebulizer.;Drug: Tobramycin inhalation solution using a PARI LC® Plus nebulizer. | Insmed Incorporated | NULL | Completed | 6 Years | N/A | All | 302 | Phase 3 | Austria;Belgium;Bulgaria;Canada;Denmark;France;Germany;Greece;Hungary;Ireland;Italy;Netherlands;Poland;Serbia;Slovakia;Spain;Sweden;United Kingdom |
| 2 | NCT03905642 (ClinicalTrials.gov) | January 8, 2009 | 2/4/2019 | Study of Dose Escalation of Liposomal Amikacin for Inhalation (ARIKAYCE™) - Extension Phase | Multidose Safety and Tolerability Study of Dose Escalation of Liposomal Amikacin for Inhalation (ARIKAYCE™) in Cystic Fibrosis Patients With Chronic Infections Due to Pseudomonas Aeruginosa | Cystic Fibrosis | Drug: Arikayce™ | Insmed Incorporated | NULL | Completed | 6 Years | N/A | All | 49 | Phase 2 | Belgium;Hungary;North Macedonia;Poland;Serbia;Slovakia;Ukraine;Macedonia, The Former Yugoslav Republic of |
| 3 | NCT00558844 (ClinicalTrials.gov) | January 2008 | 13/11/2007 | Safety/Tolerability Study of Arikayce™ in Cystic Fibrosis Patients With Chronic Infection Due to Pseudomonas Aeruginosa | Phase 1b/2a Multidose Safety and Tolerability Study of Liposomal Amikacin for Inhalation (Arikayce™) in Cystic Fibrosis Patient With Chronic Infections Due to Pseudomonas Aeruginosa. | Cystic Fibrosis | Drug: Arikayce™ 560 mg;Drug: Placebo for 560 mg;Drug: Arikayce™ 70 mg;Drug: Arikayce™ 140 mg;Drug: Placebo for 70 mg / 140 mg | Insmed Incorporated | NULL | Completed | 6 Years | N/A | All | 41 | Phase 1;Phase 2 | United States |