Aerovanc (DrugBank: -)
1 diseaseID | Disease name (Link within this page) | Number of trials |
---|---|---|
299 | Cystic fibrosis | 4 |
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 | NCT03181932 (ClinicalTrials.gov) | September 26, 2017 | 1/6/2017 | A Study of AeroVanc for the Treatment of MRSA Infection in CF Patients | A Phase III, Randomized, Double-blind, Placebo-controlled Study of AeroVanc for the Treatment of Persistent Methicillin-resistant Staphylococcus Aureus Lung Infection in Cystic Fibrosis Patients | MRSA;Cystic Fibrosis | Drug: Vancomycin inhalation powder;Drug: Placebo inhalation powder | Savara Inc. | NULL | Active, not recruiting | 6 Years | N/A | All | 200 | Phase 3 | United States;Canada |
2 | NCT01746095 (ClinicalTrials.gov) | March 2013 | 6/12/2012 | Efficacy and Safety Study of AeroVanc for the Treatment of Persistent MRSA Lung Infection in Cystic Fibrosis Patients | A Phase 2, Randomized, Double Blind, Placebo-controlled Study of AeroVanc for the Treatment of Persistent Methicillin-resistant Staphylococcus Aureus Lung Infection in Cystic Fibrosis Patients | Cystic Fibrosis | Drug: Vancomycin hydrochloride inhalation powder;Drug: Placebo inhalation powder | Savara Inc. | Synteract, Inc.;Cystic Fibrosis Foundation | Completed | 12 Years | N/A | All | 87 | Phase 2 | United States |
3 | NCT01537666 (ClinicalTrials.gov) | November 2011 | 17/2/2012 | Inhaled Vancomycin Tolerability, Safety and Pharmacokinetics | Phase I, Reference-controlled, Dose Escalating Study to Examine the Pharmacokinetics and Safety of AeroVanc Inhalation Powder. | Healthy;Cystic Fibrosis | Drug: AeroVanc;Drug: IV vancomycin hydrochloride | Savara Inc. | INC Research Limited | Completed | 18 Years | 50 Years | All | 25 | Phase 1 | Australia |
4 | EUCTR2005-000313-35-GB (EUCTR) | 13/04/2005 | 17/03/2005 | A Phase I/II Study to Investigate the Efficacy and Safety of AER 002 in Cystic Fibrosis Given at 3 mg, 10 mg, and 30 mg Doses in Single then Multiple Ascending Doses and to Determine Efficacy of the Highest Tolerable Dose in a 4-Week Proof of Concept Study | A Phase I/II Study to Investigate the Efficacy and Safety of AER 002 in Cystic Fibrosis Given at 3 mg, 10 mg, and 30 mg Doses in Single then Multiple Ascending Doses and to Determine Efficacy of the Highest Tolerable Dose in a 4-Week Proof of Concept Study | Cystic Fibrosis MedDRA version: 7.1;Level: LLT;Classification code 10011762 | Product Name: Recombinant truncated SPINT2 protease inhibitor Product Code: AER002 | Aerovance Inc | NULL | Not Recruiting | Female: yes Male: yes | 106 | Phase 1;Phase 2 | United Kingdom |