299. 嚢胞性線維症 Cystic fibrosis Clinical trials / Disease details
臨床試験数 : 1,695 / 薬物数 : 1,527 - (DrugBank : 268) / 標的遺伝子数 : 111 - 標的パスウェイ数 : 174
| 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 | NCT02535130 (ClinicalTrials.gov) | August 2015 | 24/8/2015 | Evaluation of Nebulization and Positive Expiratory Pressure Combination | Cystic Fibrosis;Healthy Subjects | Device: Positive expiratory pressure;Drug: amikacine nebulization | Cliniques universitaires Saint-Luc- Université Catholique de Louvain | NULL | Recruiting | 16 Years | 55 Years | Both | 15 | N/A | Belgium | |
| 2 | NCT02489955 (ClinicalTrials.gov) | February 2015 | 18/5/2015 | Antibiotic Nephrotoxicity in Adult Patients With Cystic Fibrosis | Prospective Randomised Trial of 'Area Under the Curve' (AUC) Dosing Strategy for Intravenous Tobramycin Versus Standard Trough Dosing for Pulmonary Exacerbations in Adult Patients With Cystic Fibrosis (CF) | Cystic Fibrosis | Drug: Amikacin;Drug: Tobramycin;Drug: Colomycin | The Leeds Teaching Hospitals NHS Trust | NULL | Recruiting | 18 Years | N/A | Both | N/A | United Kingdom | |
| 3 | ChiCTR-IPC-15005915 | 2015-01-31 | 2014-07-06 | A Randomized, Controlled Study of Combined the therapy of bronchoalveolar lavage and Amikacin injection in Patients with Acute Exacerbation of Bronchiectasis | A Randomized, Controlled Study of Combined the therapy of bronchoalveolar lavage and Amikacin injection in Patients with Acute Exacerbation of Bronchiectasis | non-cystic fibrosis bronchiectasis | Experimental group:Routine treatment combining with the therapy of bronchoalveolar lavage and local drug injection (Amikacin); | Department of Respiratory Medicine, Shanghai Pulmonary Hospital, Tongji University School of Medicine | NULL | Recruiting | 18 | 80 | Both | Experimental group:50; | NULL | |
| 4 | NCT02084043 (ClinicalTrials.gov) | March 2014 | 8/3/2014 | In Vitro Assessment of a Breath-synchronized Vibrating Mesh Nebulizer During Non Invasive Ventilation | In Vitro Comparison of Continuous and Breath-synchronized Vibrating Mesh Nebulizer During Non Invasive Ventilation: Analysis of Inhaled and Lost Doses. | Respiratory Diseases;Lung Diseases;Cystic Fibrosis;COPD;Asthma | Drug: Nebulization of Amikacin during NIV (RR: 15 cycles/minute);Drug: Nebulization of Amikacin during NIV (RR: 25 cycles/minute) | University Hospital St Luc, Brussels | Université Catholique de Louvain;University of Applied Sciences of Western Switzerland;School of Gestion and Engineering Vaud, Switzerland | Completed | N/A | N/A | Both | 3 | N/A | Belgium;Switzerland |
| 5 | NCT02081963 (ClinicalTrials.gov) | March 2014 | 6/3/2014 | Combined Administration of Nebulized Amikacin in Patients With Acute Exacerbation of Non-Cystic Fibrosis Bronchiectasis | A Randomized, Controlled Study of Combined Administration of Nebulized Amikacin in Patients With Acute Exacerbation of Non-Cystic Fibrosis Bronchiectasis | Non-Cystic Fibrosis Bronchiectasis | Drug: Amikacin;Drug: Normal saline | Qilu Hospital of Shandong University | NULL | Completed | 18 Years | 80 Years | All | 178 | Phase 4 | China |
| 6 | EUCTR2011-000443-24-NL (EUCTR) | 25/04/2013 | 06/07/2011 | Long Term Safety and Tolerability Study of Arikace™ in Cystic Fibrosis Patients with Chronic Infection due to Pseudomonas aeruginosa | Long Term Safety and Tolerability Study of Open-Label Liposomal Amikacin for Inhalation (Arikace™) in Cystic Fibrosis Patients with Chronic Infection due to Pseudomonas aeruginosa | Pseudomonas aeruginosa pulmonary infection / colonisation in patientswith cystic fibrosis MedDRA version: 18.0;Level: PT;Classification code 10011763;Term: Cystic fibrosis lung;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Product Name: Liposomal Amikacin (Arikace™) INN or Proposed INN: AMIKACIN SULFATE | Insmed Incorporated | NULL | Not Recruiting | Female: yes Male: yes | 250 | Phase 3 | United States;Slovakia;Greece;Spain;Ireland;Austria;United Kingdom;Italy;France;Hungary;Canada;Poland;Belgium;Australia;Denmark;Bulgaria;Netherlands;Germany;New Zealand;Sweden | ||
| 7 | EUCTR2011-000443-24-DK (EUCTR) | 14/12/2012 | 22/07/2011 | Long Term Safety and Tolerability Study of Arikace™ in Cystic Fibrosis Patients with Chronic Infection due to Pseudomonas aeruginosa | Long Term Safety and Tolerability Study of Open-Label Liposomal Amikacin for Inhalation (Arikace™) in Cystic Fibrosis Patients with Chronic Infection due to Pseudomonas aeruginosa | Pseudomonas aeruginosa pulmonary infection / colonisation in patientswith cystic fibrosis MedDRA version: 18.0;Level: PT;Classification code 10011763;Term: Cystic fibrosis lung;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Product Name: Liposomal Amikacin (Arikace™) INN or Proposed INN: AMIKACIN SULFATE | Insmed Incorporated | NULL | Not Recruiting | Female: yes Male: yes | 250 | United States;Slovakia;Greece;Spain;Ireland;Austria;United Kingdom;Italy;France;Hungary;Canada;Poland;Belgium;Denmark;Australia;Bulgaria;Germany;Netherlands;New Zealand;Sweden | |||
| 8 | NCT01316276 (ClinicalTrials.gov) | October 5, 2012 | 14/3/2011 | Extension Study of Liposomal Amikacin for Inhalation in Cystic Fibrosis (CF) Patients With Chronic Pseudomonas Aeruginosa (Pa) Infection | Long Term Safety and Tolerability Study of Open-Label Liposomal Amikacin for Inhalation (ARIKACE™) in Cystic Fibrosis Patients With Chronic Infection Due to Pseudomonas Aeruginosa | Cystic Fibrosis | Drug: Liposomal amikacin for inhalation | Insmed Incorporated | NULL | Completed | 6 Years | N/A | All | 206 | Phase 3 | Austria;Belgium;Bulgaria;Canada;Denmark;France;Germany;Greece;Hungary;Ireland;Italy;Netherlands;Poland;Serbia;Slovakia;Spain;United Kingdom |
| 9 | EUCTR2011-000441-20-NL (EUCTR) | 11/09/2012 | 06/07/2011 | Efficacy, safety and tolerability of Arikace™ compared to TOBI in Cystic Fibrosis patients with chronic infection due to Pseudomonas aeruginosa | Randomized, open-label, active-controlled, multicenter study to assess the efficacy, safety and tolerability of Arikace™ in Cystic Fibrosis patients with chronic infection due to Pseudomonas aeruginosa | Pseudomonas aeruginosa pulmonary infection / colonisation in patients with cystic fibrosis MedDRA version: 13.1;Level: PT;Classification code 10011763;Term: Cystic fibrosis lung;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Product Name: Liposomal Amikacin (Arikace™) INN or Proposed INN: AMIKACIN SULFATE Trade Name: TOBI 300mg/5ml Nebuliser solution INN or Proposed INN: TOBRAMYCIN | Insmed Incorporated | NULL | Not Recruiting | Female: yes Male: yes | 300 | Italy;France;Hungary;Canada;Belgium;Poland;Denmark;Bulgaria;Netherlands;Germany;United States;Slovakia;Greece;Spain;Ireland;Austria;United Kingdom | |||
| 10 | NCT02201082 (ClinicalTrials.gov) | September 2012 | 20/2/2014 | Evaluation of the Timing of the Nebulization Related to the Physiotherapy Session | Cystic Fibrosis | Procedure: Airway clearance technique;Drug: Amikacin nebulization | Cliniques universitaires Saint-Luc- Université Catholique de Louvain | NULL | Completed | 16 Years | 50 Years | Both | 15 | N/A | Belgium | |
| 11 | EUCTR2011-000441-20-BG (EUCTR) | 13/06/2012 | 03/05/2012 | Efficacy, safety and tolerability of Arikace™ compared to TOBI in Cystic Fibrosis patients with chronic infection due to Pseudomonas aeruginosa | Randomized, open-label, active-controlled, multicenter study to assess the efficacy, safety and tolerability of Arikace™ in Cystic Fibrosis patients with chronic infection due to Pseudomonas aeruginosa | Pseudomonas aeruginosa pulmonary infection / colonisation in patients with cystic fibrosis MedDRA version: 17.1;Level: PT;Classification code 10011763;Term: Cystic fibrosis lung;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Product Name: Liposomal Amikacin (Arikace™) INN or Proposed INN: AMIKACIN SULFATE Trade Name: TOBI 300mg/5ml Nebuliser solution INN or Proposed INN: TOBRAMYCIN | Insmed Incorporated | NULL | Not Recruiting | Female: yes Male: yes | 300 | Serbia;Slovakia;Greece;Spain;Ireland;Austria;Italy;United Kingdom;France;Hungary;Macedonia, the former Yugoslav Republic of;Canada;Poland;Belgium;Denmark;Bulgaria;Netherlands;Germany | |||
| 12 | EUCTR2011-000443-24-SE (EUCTR) | 24/05/2012 | 07/06/2011 | Long Term Safety and Tolerability Study of Arikace™ in Cystic Fibrosis Patients with Chronic Infection due to Pseudomonas aeruginosa | Long Term Safety and Tolerability Study of Open-Label Liposomal Amikacin for Inhalation (Arikace™) in Cystic Fibrosis Patients with Chronic Infection due to Pseudomonas aeruginosa | Pseudomonas aeruginosa pulmonary infection / colonisation in patientswith cystic fibrosis MedDRA version: 14.1;Level: PT;Classification code 10011763;Term: Cystic fibrosis lung;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Product Name: Liposomal Amikacin (Arikace™) INN or Proposed INN: AMIKACIN SULFATE | Insmed Incorporated | NULL | Not Recruiting | Female: yes Male: yes | 250 | United States;Slovakia;Greece;Spain;Ireland;Austria;United Kingdom;Italy;France;Hungary;Canada;Poland;Belgium;Australia;Denmark;Bulgaria;Germany;Netherlands;New Zealand;Sweden | |||
| 13 | EUCTR2011-000441-20-IE (EUCTR) | 02/05/2012 | 26/05/2011 | Efficacy, safety and tolerability of Arikace™ compared to TOBI in Cystic Fibrosis patients with chronic infection due to Pseudomonas aeruginosa | Randomized, open-label, active-controlled, multicenter study to assess the efficacy, safety and tolerability of Arikace™ in Cystic Fibrosis patients with chronic infection due to Pseudomonas aeruginosa | Pseudomonas aeruginosa pulmonary infection / colonisation in patients with cystic fibrosis MedDRA version: 14.1;Level: PT;Classification code 10011763;Term: Cystic fibrosis lung;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Product Name: Liposomal Amikacin (Arikace™) INN or Proposed INN: AMIKACIN SULFATE Trade Name: TOBI 300mg/5ml Nebuliser solution Product Code: TOBI INN or Proposed INN: TOBRAMYCIN | Insmed Incorporated | NULL | Not Recruiting | Female: yes Male: yes | 300 | Slovakia;Greece;Spain;Ireland;Austria;United Kingdom;Italy;France;Hungary;Canada;Belgium;Poland;Denmark;Bulgaria;Germany;Netherlands | |||
| 14 | EUCTR2011-000443-24-IT (EUCTR) | 10/04/2012 | 19/03/2012 | Long Term Safety and Tolerability Study of Arikace™ in Cystic Fibrosis Patients with Chronic Infection due to Pseudomonas aeruginosa | Long Term Safety and Tolerability Study of Open-Label Liposomal Amikacin for Inhalation (Arikace™) in Cystic Fibrosis Patients with Chronic Infection due to Pseudomonas aeruginosa | Pseudomonas aeruginosa pulmonary infection / colonisation in patients with cystic fibrosis MedDRA version: 14.1;Level: PT;Classification code 10011763;Term: Cystic fibrosis lung;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Product Name: Liposomal Amikacin Product Code: NA INN or Proposed INN: AMIKACIN SULFATE | INSMED INCORPORATED | NULL | Not Recruiting | Female: yes Male: yes | 250 | Greece;Spain;Ireland;Austria;Italy;United Kingdom;Hungary;Canada;Belgium;Denmark;Australia;Bulgaria;Germany;Netherlands;New Zealand;Sweden | |||
| 15 | EUCTR2011-000441-20-DK (EUCTR) | 29/03/2012 | 22/07/2011 | Efficacy, safety and tolerability of Arikace™ compared to TOBI in Cystic Fibrosis patients with chronic infection due to Pseudomonas aeruginosa | Randomized, open-label, active-controlled, multicenter study to assess the efficacy, safety and tolerability of Arikace™ in Cystic Fibrosis patients with chronic infection due to Pseudomonas aeruginosa | Pseudomonas aeruginosa pulmonary infection / colonisation in patients with cystic fibrosis MedDRA version: 14.1;Level: PT;Classification code 10011763;Term: Cystic fibrosis lung;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Product Name: Liposomal Amikacin (Arikace™) INN or Proposed INN: AMIKACIN SULFATE Trade Name: TOBI 300mg/5ml Nebuliser solution INN or Proposed INN: TOBRAMYCIN | Insmed Incorporated | NULL | Not Recruiting | Female: yes Male: yes | 300 | Slovakia;Greece;Spain;Ireland;Austria;Italy;United Kingdom;France;Hungary;Canada;Poland;Belgium;Denmark;Bulgaria;Netherlands;Germany | |||
| 16 | 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 |
| 17 | NCT01315691 (ClinicalTrials.gov) | February 29, 2012 | 14/3/2011 | Study to Evaluate Arikace™ in CF Patients With Chronic Infection Due to Pseudomonas Aeruginosa | Randomized, Placebo-Controlled, Double-Blind, Multicenter Study to Assess the Efficacy, Safety and Tolerability of Arikace™ in Cystic Fibrosis Patients With Chronic Infection Due to Pseudomonas Aeruginosa | Cystic Fibrosis | Drug: Liposomal amikacin for inhalation;Drug: Placebo for liposomal amikacin for inhalation | Insmed Incorporated | NULL | Withdrawn | 6 Years | N/A | All | 0 | Phase 3 | NULL |
| 18 | EUCTR2011-000441-20-BE (EUCTR) | 30/01/2012 | 25/05/2011 | Efficacy, safety and tolerability of Arikace™ compared to TOBI in Cystic Fibrosis patients with chronic infection due to Pseudomonas aeruginosa | Randomized, open-label, active-controlled, multicenter study to assess the efficacy, safety and tolerability of Arikace™ in Cystic Fibrosis patients with chronic infection due to Pseudomonas aeruginosa | Pseudomonas aeruginosa pulmonary infection / colonisation in patients with cystic fibrosis MedDRA version: 14.0;Level: PT;Classification code 10011763;Term: Cystic fibrosis lung;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Product Name: Liposomal Amikacin (Arikace™) Product Code: N/A INN or Proposed INN: AMIKACIN SULFATE Trade Name: TOBI 300mg/5ml Nebuliser solution Product Name: TOBI Product Code: N/A INN or Proposed INN: TOBRAMYCIN | Insmed Incorporated | NULL | Not Recruiting | Female: yes Male: yes | 300 | Phase 3 | Slovakia;Greece;Spain;Ireland;Austria;Italy;United Kingdom;France;Hungary;Canada;Belgium;Poland;Denmark;Bulgaria;Netherlands;Germany | ||
| 19 | EUCTR2011-000443-24-BE (EUCTR) | 30/01/2012 | 25/05/2011 | Long Term Safety and Tolerability Study of Arikace™ in Cystic Fibrosis Patients with Chronic Infection due to Pseudomonas aeruginosa | Long Term Safety and Tolerability Study of Open-Label Liposomal Amikacin for Inhalation (Arikace™) in Cystic Fibrosis Patients with Chronic Infection due to Pseudomonas aeruginosa | Pseudomonas aeruginosa pulmonary infection / colonisation in patientswith cystic fibrosis MedDRA version: 14.1;Level: PT;Classification code 10011763;Term: Cystic fibrosis lung;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Product Name: Liposomal Amikacin (Arikace™) Product Code: N/A INN or Proposed INN: AMIKACIN SULFATE | Insmed Incorporated | NULL | Not Recruiting | Female: yes Male: yes | 250 | Phase 3 | Serbia;United States;Slovakia;Greece;Spain;Ukraine;Ireland;Austria;Italy;United Kingdom;France;Hungary;Canada;Belgium;Poland;Denmark;Australia;Bulgaria;Netherlands;Germany;New Zealand;Sweden | ||
| 20 | EUCTR2011-000443-24-PL (EUCTR) | 20/01/2012 | 06/10/2011 | Long Term Safety and Tolerability Study of Arikace™ in Cystic Fibrosis Patients with Chronic Infection due to Pseudomonas aeruginosa | Long Term Safety and Tolerability Study of Open-Label Liposomal Amikacin for Inhalation (Arikace™) in Cystic Fibrosis Patients with Chronic Infection due to Pseudomonas aeruginosa | Pseudomonas aeruginosa pulmonary infection / colonisation in patientswith cystic fibrosis MedDRA version: 16.1;Level: PT;Classification code 10011763;Term: Cystic fibrosis lung;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Product Name: Liposomal Amikacin (Arikace™) INN or Proposed INN: AMIKACIN SULFATE | Insmed Incorporated | NULL | Not Recruiting | Female: yes Male: yes | 250 | Phase 3 | United States;Serbia;Slovakia;Greece;Spain;Ireland;Austria;United Kingdom;Italy;France;Hungary;Macedonia, the former Yugoslav Republic of;Canada;Poland;Belgium;Denmark;Australia;Bulgaria;Netherlands;Germany;New Zealand;Sweden | ||
| 21 | EUCTR2011-000443-24-DE (EUCTR) | 11/10/2011 | 30/05/2011 | Long Term Safety and Tolerability Study of Arikace™ in Cystic Fibrosis Patients with Chronic Infection due to Pseudomonas aeruginosa | Long Term Safety and Tolerability Study of Open-Label Liposomal Amikacin for Inhalation (Arikace™) in Cystic Fibrosis Patients with Chronic Infection due to Pseudomonas aeruginosa | Pseudomonas aeruginosa pulmonary infection / colonisation in patientswith cystic fibrosis MedDRA version: 17.1;Level: PT;Classification code 10011763;Term: Cystic fibrosis lung;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Product Name: Liposomal Amikacin (Arikace™) INN or Proposed INN: AMIKACIN SULFATE | Insmed Incorporated | NULL | Not Recruiting | Female: yes Male: yes | 250 | Slovakia;Greece;Spain;Ireland;Austria;United Kingdom;Italy;France;Hungary;Canada;Poland;Belgium;Australia;Denmark;Bulgaria;Netherlands;Germany;New Zealand;Sweden | |||
| 22 | EUCTR2011-000443-24-BG (EUCTR) | 03/10/2011 | 28/07/2011 | Long Term Safety and Tolerability Study of Arikace™ in Cystic Fibrosis Patients with Chronic Infection due to Pseudomonas aeruginosa | Long Term Safety and Tolerability Study of Open-Label Liposomal Amikacin for Inhalation (Arikace™) in Cystic Fibrosis Patients with Chronic Infection due to Pseudomonas aeruginosa | Pseudomonas aeruginosa pulmonary infection / colonisation in patientswith cystic fibrosis MedDRA version: 18.0;Level: PT;Classification code 10011763;Term: Cystic fibrosis lung;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Product Name: Liposomal Amikacin (Arikace™) INN or Proposed INN: AMIKACIN SULFATE | Insmed Incorporated | NULL | Not Recruiting | Female: yes Male: yes | 250 | Serbia;Slovakia;Greece;Spain;Ireland;Austria;United Kingdom;Italy;France;Hungary;Macedonia, the former Yugoslav Republic of;Canada;Poland;Belgium;Denmark;Australia;Bulgaria;Netherlands;Germany;New Zealand;Sweden | |||
| 23 | EUCTR2011-000442-38-BG (EUCTR) | 03/10/2011 | 05/07/2011 | Efficacy, safety and tolerability of Arikace™ compared to placebo in Cystic Fibrosis patients with chronic infection due to Pseudomonas Aeruginosa | Randomized, placebo-controlled, double-blind, multicenter study to assess the efficacy, safety and tolerability of Arikace™ in Cystic Fibrosis patients with chronic infection due to Pseudomonas Aeruginosa | Pseudomonas aeruginosa pulmonary infection / colonisation in patientswith cystic fibrosis MedDRA version: 14.1;Level: PT;Classification code 10011763;Term: Cystic fibrosis lung;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Product Name: Liposomal Amikacin (Arikace™) INN or Proposed INN: Amikacin Sulfate | Insmed Incorporated | NULL | Not Recruiting | Female: yes Male: yes | 300 | France;United States;Serbia;Macedonia, the former Yugoslav Republic of;Spain;Poland;Ukraine;Australia;Bulgaria;New Zealand;Sweden | |||
| 24 | EUCTR2011-000441-20-IT (EUCTR) | 01/10/2011 | 08/03/2012 | Efficacy, safety and tolerability of Arikace™ compared to TOBI in Cystic Fibrosis patients with chronic infection due to Pseudomonas aeruginosa | Randomized, open-label, active-controlled, multicenter study to assess the efficacy, safety and tolerability of Arikace™ in Cystic Fibrosis patients with chronic infection due to Pseudomonas aeruginosa | Pseudomonas aeruginosa pulmonary infection/colonisation in patients with cystic fibrosis MedDRA version: 14.1;Level: PT;Classification code 10011763;Term: Cystic fibrosis lung;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Product Name: Liposomal Amikacin (Arikace™) Product Code: NA INN or Proposed INN: AMIKACIN SULFATE Trade Name: Tobi INN or Proposed INN: TOBRAMYCIN | INSMED INCORPORATED | NULL | Not Recruiting | Female: yes Male: yes | 300 | Hungary;Greece;Canada;Spain;Ireland;Denmark;Austria;Bulgaria;Netherlands;United Kingdom;Italy | |||
| 25 | EUCTR2011-000443-24-ES (EUCTR) | 22/09/2011 | 03/11/2011 | Estudio de seguridad y tolerabilidad a largo plazo de la administración abierta Arikace en pacientes con fibrosis quística con infección crónica por Pseudomonas aeruginosa | Estudio de seguridad y tolerabilidad a largo plazo de la administración abierta de amicacina liposomal para inhalación (Arikace) en pacientes con fibrosis quística con infección crónica por Pseudomonas aeruginosa - NCT0131627 | Infeccion pulmonar por Pseudomonas Aeruginosa/ colonizacion en pacientes con fibrosis quistica MedDRA version: 14.0;Level: PT;Classification code 10011763;Term: Cystic fibrosis lung;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Product Name: Liposomal Amikacin (Arikace TM) INN or Proposed INN: Sulfato de amikacina | Insmed Incorporated | NULL | Not Recruiting | Female: yes Male: yes | 250 | Phase 3 | Serbia;United States;Slovakia;Greece;Spain;Ukraine;Ireland;Austria;Italy;United Kingdom;France;Hungary;Macedonia, the former Yugoslav Republic of;Canada;Poland;Belgium;Denmark;Australia;Bulgaria;Netherlands;Germany;New Zealand;Sweden | ||
| 26 | EUCTR2011-000441-20-ES (EUCTR) | 21/09/2011 | 11/11/2011 | ESTUDIO PARA EVALUAR LA EFICACIA, SEGURIDAD Y TOLERABILIDAD DE ARIKACE EN PACIENTES CON FIBROSIS QUÍSTICA CON INFECCIÓN CRÓNICA POR PSEUDOMONAS AERUGINOSA | ESTUDIO ALEATORIZADO, ABIERTO, CONTROLADO CON MEDICAMENTO ACTIVO Y MULTICÉNTRICO PARA EVALUAR LA EFICACIA, SEGURIDAD Y TOLERABILIDAD DE ARIKACE EN PACIENTES CON FIBROSIS QUÍSTICA CON INFECCIÓN CRÓNICA POR PSEUDOMONAS AERUGINOSA - TR02-108 | Infección pulmonar con Pseudomonas aeruginosa/ colonización en pacientes con fibrosis quística MedDRA version: 14.0;Level: PT;Classification code 10011763;Term: Cystic fibrosis lung;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Product Name: Amikacina liposomal (Arikace?) INN or Proposed INN: Sulfato de amikacina Trade Name: TOBI 300mg/ 5ml solución para inhalación con nebulizador INN or Proposed INN: tobramicina | Insmed Incorporated | NULL | Not Recruiting | Female: yes Male: yes | 300 | Phase 3 | United States;Slovakia;Greece;Spain;Ireland;Austria;United Kingdom;Italy;France;Hungary;Canada;Belgium;Poland;Australia;Denmark;Bulgaria;Germany;Netherlands | ||
| 27 | EUCTR2011-000442-38-ES (EUCTR) | 21/09/2011 | 11/11/2011 | Efficacy, safety and tolerability of Arikace™ compared to placebo in Cystic Fibrosis patients with chronic infection due to Pseudomonas Aeruginosa | Randomized, placebo-controlled, double-blind, multicenter study to assess the efficacy, safety and tolerability of Arikace™ in Cystic Fibrosis patients with chronic infection due to Pseudomonas AeruginosaESTUDIO ALEATORIZADO, CONTROLADO CON PLACEBO, DOBLE CIEGO Y MULTICÉNTRICO PARA EVALUAR LA EFICACIA, SEGURIDAD Y TOLERABILIDAD DE ARIKACE™ EN PACIENTES CON FIBROSIS QUÍSTICA CON INFECCIÓN CRÓNICA POR PSEUDOMONAS AERUGINOSA | Pseudomonas aeruginosa pulmonary infection / colonisation in patientswith cystic fibrosis MedDRA version: 14.0;Level: PT;Classification code 10011763;Term: Cystic fibrosis lung;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Product Name: Liposomal Amikacin (Arikace™) INN or Proposed INN: Amikacin Sulfate | Insmed Incorporated | NULL | Not Recruiting | Female: yes Male: yes | 300 | France;United States;Serbia;Macedonia, the former Yugoslav Republic of;Poland;Spain;Ukraine;Australia;Bulgaria;New Zealand;Sweden | |||
| 28 | EUCTR2011-000441-20-DE (EUCTR) | 19/09/2011 | 30/05/2011 | Efficacy, safety and tolerability of Arikace™ compared to TOBI in Cystic Fibrosis patients with chronic infection due to Pseudomonas aeruginosa | Randomized, open-label, active-controlled, multicenter study to assess the efficacy, safety and tolerability of Arikace™ in Cystic Fibrosis patients with chronic infection due to Pseudomonas aeruginosa | Pseudomonas aeruginosa pulmonary infection / colonisation in patients with cystic fibrosis MedDRA version: 14.1;Level: PT;Classification code 10011763;Term: Cystic fibrosis lung;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Product Name: Liposomal Amikacin (Arikace™) INN or Proposed INN: AMIKACIN SULFATE Trade Name: TOBI 300mg/5ml Nebuliser solution Product Name: TOBI INN or Proposed INN: TOBRAMYCIN | Insmed Incorporated | NULL | Not Recruiting | Female: yes Male: yes | 300 | Slovakia;Greece;Spain;Ireland;Austria;Italy;United Kingdom;France;Hungary;Canada;Poland;Belgium;Denmark;Bulgaria;Netherlands;Germany | |||
| 29 | EUCTR2011-000443-24-GR (EUCTR) | 09/08/2011 | 23/06/2011 | Long Term Safety and Tolerability Study of Arikace™ in Cystic Fibrosis Patients with Chronic Infection due to Pseudomonas aeruginosa | Long Term Safety and Tolerability Study of Open-Label Liposomal Amikacin for Inhalation (Arikace™) in Cystic Fibrosis Patients with Chronic Infection due to Pseudomonas aeruginosa | Pseudomonas aeruginosa pulmonary infection / colonisation in patientswith cystic fibrosis MedDRA version: 14.0;Level: PT;Classification code 10011763;Term: Cystic fibrosis lung;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Product Name: Liposomal Amikacin (Arikace™) INN or Proposed INN: AMIKACIN SULFATE | Insmed Incorporated | NULL | Not Recruiting | Female: yes Male: yes | 250 | United States;Serbia;Slovakia;Greece;Spain;Ukraine;Ireland;Austria;United Kingdom;Italy;France;Hungary;Canada;Macedonia, the former Yugoslav Republic of;Poland;Belgium;Australia;Denmark;Bulgaria;Netherlands;Germany;New Zealand;Sweden | |||
| 30 | EUCTR2011-000443-24-IE (EUCTR) | 05/08/2011 | 26/05/2011 | Long Term Safety and Tolerability Study of Arikace™ in Cystic Fibrosis Patients with Chronic Infection due to Pseudomonas aeruginosa | Long Term Safety and Tolerability Study of Open-Label Liposomal Amikacin for Inhalation (Arikace™) in Cystic Fibrosis Patients with Chronic Infection due to Pseudomonas aeruginosa | Pseudomonas aeruginosa pulmonary infection / colonisation in patientswith cystic fibrosis MedDRA version: 18.0;Level: PT;Classification code 10011763;Term: Cystic fibrosis lung;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Product Name: Liposomal Amikacin (Arikace™) INN or Proposed INN: AMIKACIN SULFATE | Insmed Incorporated | NULL | Not Recruiting | Female: yes Male: yes | 250 | United States;Slovakia;Greece;Spain;Ireland;Austria;Italy;United Kingdom;France;Hungary;Canada;Poland;Belgium;Australia;Denmark;Bulgaria;Netherlands;Germany;New Zealand;Sweden | |||
| 31 | EUCTR2011-000441-20-GB (EUCTR) | 03/08/2011 | 24/05/2011 | Efficacy, safety and tolerability of Arikace™ compared to TOBI in Cystic Fibrosis patients with chronic infection due to Pseudomonas aeruginosa | Randomized, open-label, active-controlled, multicenter study to assess the efficacy, safety and tolerability of Arikace™ in Cystic Fibrosis patients with chronic infection due to Pseudomonas aeruginosa | Pseudomonas aeruginosa pulmonary infection / colonisation in patients with cystic fibrosis MedDRA version: 14.0;Level: PT;Classification code 10011763;Term: Cystic fibrosis lung;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Product Name: Liposomal Amikacin (Arikace™) INN or Proposed INN: AMIKACIN SULFATE Trade Name: TOBI 300mg/5ml Nebuliser solution INN or Proposed INN: TOBRAMYCIN | Insmed Incorporated | NULL | Not Recruiting | Female: yes Male: yes | 300 | Slovakia;Greece;Spain;Ireland;Austria;United Kingdom;Italy;France;Hungary;Canada;Belgium;Poland;Denmark;Bulgaria;Germany;Netherlands | |||
| 32 | EUCTR2011-000443-24-GB (EUCTR) | 03/08/2011 | 24/05/2011 | Long Term Safety and Tolerability Study of Arikace™ in Cystic Fibrosis Patients with Chronic Infection due to Pseudomonas aeruginosa | Long Term Safety and Tolerability Study of Open-Label Liposomal Amikacin for Inhalation (Arikace™) in Cystic Fibrosis Patients with Chronic Infection due to Pseudomonas aeruginosa | Pseudomonas aeruginosa pulmonary infection / colonisation in patientswith cystic fibrosis MedDRA version: 18.0;Level: PT;Classification code 10011763;Term: Cystic fibrosis lung;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Product Name: Liposomal Amikacin (Arikace™) INN or Proposed INN: AMIKACIN SULFATE | Insmed Incorporated | NULL | Not Recruiting | Female: yes Male: yes | 250 | Phase 3 | United States;Slovakia;Greece;Spain;Ireland;Austria;Italy;United Kingdom;France;Hungary;Canada;Poland;Belgium;Australia;Denmark;Bulgaria;Netherlands;Germany;New Zealand;Sweden | ||
| 33 | EUCTR2011-000443-24-FR (EUCTR) | 28/07/2011 | 31/05/2011 | Long Term Safety and Tolerability Study of Arikace™ in Cystic Fibrosis Patients with Chronic Infection due to Pseudomonas aeruginosa | Long Term Safety and Tolerability Study of Open-Label Liposomal Amikacin for Inhalation (Arikace™) in Cystic Fibrosis Patients with Chronic Infection due to Pseudomonas aeruginosa | Pseudomonas aeruginosa pulmonary infection / colonisation in patientswith cystic fibrosis MedDRA version: 13.1;Level: PT;Classification code 10011763;Term: Cystic fibrosis lung;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Product Name: Liposomal Amikacin (Arikace™) Product Code: NA INN or Proposed INN: AMIKACIN SULFATE | Insmed Incorporated | NULL | Not Recruiting | Female: yes Male: yes | 250 | Phase 3 | United States;Serbia;Slovakia;Greece;Spain;Ukraine;Ireland;Austria;Italy;United Kingdom;France;Hungary;Canada;Macedonia, the former Yugoslav Republic of;Belgium;Poland;Denmark;Australia;Bulgaria;Netherlands;Germany;New Zealand;Sweden | ||
| 34 | EUCTR2011-000443-24-AT (EUCTR) | 22/07/2011 | 27/06/2011 | Long Term Safety and Tolerability Study of Arikace™ in Cystic Fibrosis Patients with Chronic Infection due to Pseudomonas aeruginosa | Long Term Safety and Tolerability Study of Open-Label Liposomal Amikacin for Inhalation (Arikace™) in Cystic Fibrosis Patients with Chronic Infection due to Pseudomonas aeruginosa | Pseudomonas aeruginosa pulmonary infection / colonisation in patientswith cystic fibrosis MedDRA version: 18.0;Level: PT;Classification code 10011763;Term: Cystic fibrosis lung;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Product Name: Liposomal Amikacin (Arikace™) INN or Proposed INN: AMIKACIN SULFATE | Insmed Incorporated | NULL | Not Recruiting | Female: yes Male: yes | 250 | United States;Slovakia;Greece;Spain;Ireland;Austria;United Kingdom;Italy;France;Hungary;Canada;Poland;Belgium;Australia;Denmark;Bulgaria;Germany;Netherlands;New Zealand;Sweden | |||
| 35 | EUCTR2011-000441-20-AT (EUCTR) | 19/07/2011 | 21/06/2011 | Efficacy, safety and tolerability of Arikace™ compared to TOBI in Cystic Fibrosis patients with chronic infection due to Pseudomonas aeruginosa | Randomized, open-label, active-controlled, multicenter study to assess the efficacy, safety and tolerability of Arikace™ in Cystic Fibrosis patients with chronic infection due to Pseudomonas aeruginosa | Pseudomonas aeruginosa pulmonary infection / colonisation in patients with cystic fibrosis MedDRA version: 14.1;Level: PT;Classification code 10011763;Term: Cystic fibrosis lung;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Product Name: Liposomal Amikacin (Arikace™) INN or Proposed INN: AMIKACIN SULFATE Trade Name: TOBI 300mg/5ml Nebuliser solution INN or Proposed INN: TOBRAMYCIN | Insmed Incorporated | NULL | Not Recruiting | Female: yes Male: yes | 300 | Slovakia;Greece;Spain;Ireland;Austria;United Kingdom;Italy;France;Hungary;Canada;Belgium;Poland;Denmark;Bulgaria;Germany;Netherlands | |||
| 36 | EUCTR2011-000441-20-GR (EUCTR) | 15/07/2011 | 22/06/2011 | Efficacy, safety and tolerability of Arikace™ compared to TOBI in Cystic Fibrosis patients with chronic infection due to Pseudomonas aeruginosa | Randomized, open-label, active-controlled, multicenter study to assess the efficacy, safety and tolerability of Arikace™ in Cystic Fibrosis patients with chronic infection due to Pseudomonas aeruginosa | Pseudomonas aeruginosa pulmonary infection / colonisation in patients with cystic fibrosis MedDRA version: 14.0;Level: PT;Classification code 10011763;Term: Cystic fibrosis lung;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Product Name: Liposomal Amikacin (Arikace™) INN or Proposed INN: AMIKACIN SULFATE Trade Name: TOBI 300mg/5ml Nebuliser solution INN or Proposed INN: TOBRAMYCIN | Insmed Incorporated | NULL | Not Recruiting | Female: yes Male: yes | 300 | United States;Slovakia;Greece;Spain;Ireland;Austria;United Kingdom;Italy;France;Hungary;Canada;Belgium;Poland;Denmark;Bulgaria;Germany;Netherlands | |||
| 37 | EUCTR2011-000441-20-SK (EUCTR) | 04/07/2011 | 25/11/2014 | Efficacy, safety and tolerability of Arikace™ compared to TOBI in Cystic Fibrosis patients with chronic infection due to Pseudomonas aeruginosa | Randomized, open-label, active-controlled, multicenter study to assess the efficacy, safety and tolerability of Arikace™ in Cystic Fibrosis patients with chronic infection due to Pseudomonas aeruginosa | Pseudomonas aeruginosa pulmonary infection / colonisation in patients with cystic fibrosis MedDRA version: 17.1;Level: PT;Classification code 10011763;Term: Cystic fibrosis lung;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Product Name: Liposomal Amikacin (Arikace™) INN or Proposed INN: AMIKACIN SULFATE Trade Name: TOBI 300mg/5ml Nebuliser solution INN or Proposed INN: TOBRAMYCIN | Insmed Incorporated | NULL | Not Recruiting | Female: yes Male: yes | 300 | Serbia;Slovakia;Greece;Spain;Ireland;Austria;United Kingdom;Italy;France;Hungary;Macedonia, the former Yugoslav Republic of;Canada;Poland;Belgium;Denmark;Bulgaria;Netherlands;Germany | |||
| 38 | EUCTR2011-000443-24-SK (EUCTR) | 04/07/2011 | 20/02/2014 | Long Term Safety and Tolerability Study of Arikace™ in Cystic Fibrosis Patients with Chronic Infection due to Pseudomonas aeruginosa | Long Term Safety and Tolerability Study of Open-Label Liposomal Amikacin for Inhalation (Arikace™) in Cystic Fibrosis Patients with Chronic Infection due to Pseudomonas aeruginosa | Pseudomonas aeruginosa pulmonary infection / colonisation in patientswith cystic fibrosis MedDRA version: 16.1;Level: PT;Classification code 10011763;Term: Cystic fibrosis lung;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Product Name: Liposomal Amikacin (Arikace™) INN or Proposed INN: AMIKACIN SULFATE | Insmed Incorporated | NULL | Not Recruiting | Female: yes Male: yes | 250 | Phase 3 | Germany;New Zealand;Sweden;United States;Serbia;Slovakia;Greece;Spain;Ireland;Austria;United Kingdom;Italy;France;Hungary;Macedonia, the former Yugoslav Republic of;Canada;Poland;Belgium;Australia;Denmark;Bulgaria;Netherlands | ||
| 39 | EUCTR2011-000441-20-HU (EUCTR) | 29/06/2011 | 20/04/2011 | Efficacy, safety and tolerability of Arikace™ compared to TOBI in Cystic Fibrosis patients with chronic infection due to Pseudomonas aeruginosa | Randomized, open-label, active-controlled, multicenter study to assess the efficacy, safety and tolerability of Arikace™ in Cystic Fibrosis patients with chronic infection due to Pseudomonas aeruginosa | Pseudomonas aeruginosa pulmonary infection / colonisation in patients with cystic fibrosis MedDRA version: 14.0;Level: PT;Classification code 10011763;Term: Cystic fibrosis lung;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Product Name: Liposomal Amikacin (Arikace™) INN or Proposed INN: AMIKACIN SULFATE Trade Name: TOBI 300mg/5ml Nebuliser solution INN or Proposed INN: TOBRAMYCIN | Insmed Incorporated | NULL | Not Recruiting | Female: yes Male: yes | 300 | Slovakia;Greece;Spain;Ireland;Austria;United Kingdom;Italy;France;Hungary;Canada;Belgium;Poland;Denmark;Bulgaria;Germany;Netherlands | |||
| 40 | EUCTR2011-000443-24-HU (EUCTR) | 29/06/2011 | 11/05/2011 | Long Term Safety and Tolerability Study of Arikace™ in Cystic Fibrosis Patients with Chronic Infection due to Pseudomonas aeruginosa | Long Term Safety and Tolerability Study of Open-Label Liposomal Amikacin for Inhalation (Arikace™) in Cystic Fibrosis Patients with Chronic Infection due to Pseudomonas aeruginosa | Pseudomonas aeruginosa pulmonary infection / colonisation in patientswith cystic fibrosis MedDRA version: 14.0;Level: PT;Classification code 10011763;Term: Cystic fibrosis lung;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Product Name: Liposomal Amikacin (Arikace™) INN or Proposed INN: AMIKACIN SULFATE | Insmed Incorporated | NULL | Not Recruiting | Female: yes Male: yes | 250 | United States;Slovakia;Greece;Spain;Ireland;Austria;Italy;United Kingdom;France;Hungary;Canada;Poland;Belgium;Australia;Denmark;Bulgaria;Netherlands;Germany;New Zealand;Sweden | |||
| 41 | 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 |
| 42 | 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 |
| 43 | EUCTR2006-006980-22-BE (EUCTR) | 27/06/2007 | 19/07/2007 | MULTIDOSE SAFETY AND TOLERABILITY STUDY OF DOSE ESCALATION OF LIPOSOMAL AMIKACIN FOR INHALATION (ARIKACE™) IN CYSTIC FIBROSIS PATIENTS WITH CHRONIC INFECTIONS DUE TO PSEUDOMONAS AERUGINOSA | MULTIDOSE SAFETY AND TOLERABILITY STUDY OF DOSE ESCALATION OF LIPOSOMAL AMIKACIN FOR INHALATION (ARIKACE™) IN CYSTIC FIBROSIS PATIENTS WITH CHRONIC INFECTIONS DUE TO PSEUDOMONAS AERUGINOSA | Cystic fibrosis MedDRA version: 9.1;Level: LLT;Classification code 10011762;Term: Cystic fibrosis | Product Name: Liposomal Amikacin (Arikace™) INN or Proposed INN: Amikacin sulfate | Transave, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 60 | Hungary;Belgium | |||
| 44 | EUCTR2006-006980-22-HU (EUCTR) | 14/06/2007 | 03/04/2007 | MULTIDOSE SAFETY AND TOLERABILITY STUDY OF DOSE ESCALATION OF LIPOSOMAL AMIKACIN FOR INHALATION (ARIKACE™) IN CYSTIC FIBROSIS PATIENTS WITH CHRONIC INFECTIONS DUE TO PSEUDOMONAS AERUGINOSA | MULTIDOSE SAFETY AND TOLERABILITY STUDY OF DOSE ESCALATION OF LIPOSOMAL AMIKACIN FOR INHALATION (ARIKACE™) IN CYSTIC FIBROSIS PATIENTS WITH CHRONIC INFECTIONS DUE TO PSEUDOMONAS AERUGINOSA | Cystic fibrosis MedDRA version: 9.1;Level: LLT;Classification code 10011762;Term: Cystic fibrosis | Product Name: Liposomal Amikacin (Arikace™) | Transave, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 60 | Hungary;Belgium | |||
| 45 | EUCTR2006-006980-22-SK (EUCTR) | 17/05/2007 | 23/04/2007 | MULTIDOSE SAFETY AND TOLERABILITY STUDY OF DOSE ESCALATION OF LIPOSOMAL AMIKACIN FOR INHALATION (ARIKACE™) IN CYSTIC FIBROSIS PATIENTS WITH CHRONIC INFECTIONS DUE TO PSEUDOMONAS AERUGINOSA | MULTIDOSE SAFETY AND TOLERABILITY STUDY OF DOSE ESCALATION OF LIPOSOMAL AMIKACIN FOR INHALATION (ARIKACE™) IN CYSTIC FIBROSIS PATIENTS WITH CHRONIC INFECTIONS DUE TO PSEUDOMONAS AERUGINOSA | Cystic fibrosis MedDRA version: 9.1;Level: LLT;Classification code 10011762;Term: Cystic fibrosis | Product Name: Liposomal Amikacin (Arikace™) | Transave, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 60 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | Hungary;Slovakia;Poland;Belgium | ||
| 46 | NCT00777296 (ClinicalTrials.gov) | February 22, 2007 | 15/10/2008 | Multidose Safety and Tolerability Study of Dose Escalation of Liposomal Amikacin for Inhalation (ARIKACE™) | Phase 2a Multidose Safety and Tolerability Study of Dose Escalation of Liposomal Amikacin for Inhalation (ARIKACE™) In Cystic Fibrosis Patients With Chronic Infections Due To Pseudomonas Aeruginosa. | Cystic Fibrosis | Drug: ARIKACE™;Drug: Placebo | Insmed Incorporated | NULL | Completed | 6 Years | N/A | All | 66 | Phase 1/Phase 2 | Belgium;Hungary;North Macedonia;Poland;Serbia;Slovakia;Ukraine;Bulgaria;Macedonia, The Former Yugoslav Republic of |
| 47 | EUCTR2005-004389-17-HU (EUCTR) | 28/12/2005 | 24/10/2005 | SAFETY AND TOLERABILITY STUDY OF SLIT AMIKACIN 500 MG ONCE DAILY FOR 14 DAYS BY INHALATION IN CYSTIC FIBROSIS STUDY SUBJECTS CHRONICALLY INFECTED WITH PSEUDOMONAS AERUGINOSA | SAFETY AND TOLERABILITY STUDY OF SLIT AMIKACIN 500 MG ONCE DAILY FOR 14 DAYS BY INHALATION IN CYSTIC FIBROSIS STUDY SUBJECTS CHRONICALLY INFECTED WITH PSEUDOMONAS AERUGINOSA | Cystic Fibrosis with mild to moderate obstructive lung disease and chronic infection with Pseudomonas aeruginosa | Product Name: SLIT Amikacin Product Code: TR02 INN or Proposed INN: amikacin Other descriptive name: amikin, amiklin, amicacin, BB-K8, Biklin, Fabianol, Kaminax, Mikavir, Novamin, Pierami | Transave, Inc | NULL | Not Recruiting | Female: yes Male: yes | 15 | Phase 2 | Hungary | ||
| 48 | EUCTR2005-004899-21-BE (EUCTR) | 22/12/2005 | 12/01/2006 | Safety and tolerability study of SLIT(TM) Amikacin 500 mg once daily for 14 days by inhalation in cystic fibrosis study subjects chronically infected with Pseudomonas aeruginosa. - NA | Safety and tolerability study of SLIT(TM) Amikacin 500 mg once daily for 14 days by inhalation in cystic fibrosis study subjects chronically infected with Pseudomonas aeruginosa. - NA | Cystic Fibrosis | Product Name: SLIT(TM) Amikacin Product Code: TR02 INN or Proposed INN: Amikacin Other descriptive name: amikin®, amiklin, amicacin, BB-K8, Biklin®, Fabianol®, Kaminax, Mikavir, Novamin®, Pierami | Transave, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 15 | Belgium | |||
| 49 | NCT00153634 (ClinicalTrials.gov) | March 2004 | 8/9/2005 | Standard vs. Biofilm Susceptibility Testing in Cystic Fibrosis (CF) | Standard vs. Biofilm Susceptibility Testing in CF | Cystic Fibrosis;Chronic Bronchitis | Drug: IV amikacin;Drug: PO azithromycin;Drug: IV ceftazidime;Drug: PO ciprofloxacin;Drug: IV meropenem;Drug: IV piperacillin-tazobactam;Drug: IV ticarcillin-clavulanate;Drug: IV tobramycin | Seattle Children's Hospital | Cystic Fibrosis Foundation Therapeutics | Completed | 14 Years | N/A | Both | 75 | N/A | United States |
| 50 | EUCTR2011-000442-38-PL (EUCTR) | 01/08/2011 | Efficacy, safety and tolerability of Arikace™ compared to placebo in Cystic Fibrosis patients with chronic infection due to Pseudomonas Aeruginosa | Randomized, placebo-controlled, double-blind, multicenter study to assess the efficacy, safety and tolerability of Arikace™ in Cystic Fibrosis patients with chronic infection due to Pseudomonas Aeruginosa | Pseudomonas aeruginosa pulmonary infection / colonisation in patientswith cystic fibrosis MedDRA version: 14.0;Level: PT;Classification code 10011763;Term: Cystic fibrosis lung;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Product Name: Liposomal Amikacin (Arikace™) INN or Proposed INN: Amikacin Sulfate | Insmed Incorporated | NULL | Not Recruiting | Female: yes Male: yes | 300 | Phase 3 | France;United States;Serbia;Macedonia, the former Yugoslav Republic of;Spain;Poland;Ukraine;Australia;Bulgaria;New Zealand;Sweden | |||
| 51 | EUCTR2006-006980-22-PL (EUCTR) | 22/08/2007 | MULTIDOSE SAFETY AND TOLERABILITY STUDY OF DOSE ESCALATION OF LIPOSOMAL AMIKACIN FOR INHALATION (ARIKACE™) IN CYSTIC FIBROSIS PATIENTS WITH CHRONIC INFECTIONS DUE TO PSEUDOMONAS AERUGINOSA | MULTIDOSE SAFETY AND TOLERABILITY STUDY OF DOSE ESCALATION OF LIPOSOMAL AMIKACIN FOR INHALATION (ARIKACE™) IN CYSTIC FIBROSIS PATIENTS WITH CHRONIC INFECTIONS DUE TO PSEUDOMONAS AERUGINOSA | Cystic fibrosis MedDRA version: 9.1;Level: LLT;Classification code 10011762;Term: Cystic fibrosis | Product Name: Liposomal Amikacin (Arikace™) INN or Proposed INN: AMIKACIN SULFATE | Transave, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 60 | Phase 2 | Hungary;Slovakia;Belgium;Poland |