Spx-101 (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 | 5 |
| 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 | EUCTR2016-005230-30-IT (EUCTR) | 15/11/2017 | 05/11/2020 | A research study to find out if SPX-101 helps people with Cystic Fibrosis and to find out if it is safe. | A Randomized, Double-Blind, Placebo-Controlled Phase II Study to Evaluate the Efficacy and Safety of SPX-101 Inhalation Solution in Subjects with Cystic Fibrosis (HOPE-1 STUDY: HYDRATION FOR OPTIMAL PULMONARY EFFECTIVENESS) - HOPE-1 Study: Hydration for Optimal Pulmonary Effectiveness | Cystic Fibrosis MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Product Name: SPX-101 Product Code: [SPX-101] INN or Proposed INN: SPX-101 | SPYRYX BIOSCIENCES, INC. | NULL | Not Recruiting | Female: yes Male: yes | 90 | Phase 2 | Portugal;France;Canada;Australia;United Kingdom;Italy | ||
| 2 | EUCTR2016-005230-30-PT (EUCTR) | 28/08/2017 | 31/05/2017 | A research study to find out if SPX-101 helps people with Cystic Fibrosis and to find out if it is safe. | A Randomized, Double-Blind, Placebo-Controlled Phase II Study to Evaluate the Efficacy and Safety of SPX-101 Inhalation Solution in Subjects with Cystic Fibrosis (HOPE-1 STUDY: HYDRATION FOR OPTIMAL PULMONARY EFFECTIVENESS) - HOPE-1 Study: Hydration for Optimal Pulmonary Effectiveness | Cystic Fibrosis MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Product Name: SPX-101 INN or Proposed INN: SPX-101 Product Name: SPX-101 INN or Proposed INN: SPX-101 | Spyryx Biosciences, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 90 | Phase 2 | France;Portugal;Canada;Australia;Italy;United Kingdom | ||
| 3 | NCT03229252 (ClinicalTrials.gov) | August 1, 2017 | 14/7/2017 | An Efficacy and Safety Study of SPX-101 Inhalation Solution in Subjects With Cystic Fibrosis | A Randomized, Double-blind, Placebo-controlled Phase II Study to Evaluate the Efficacy and Safety of SPX-101 Inhalation Solution in Subjects With Cystic Fibrosis (HOPE-1 Study: Hydration for Optimal Pulmonary Effectiveness) | Cystic Fibrosis | Drug: Placebo Inhalation Solution;Drug: SPX-101 | Spyryx Biosciences, Inc. | NULL | Completed | 18 Years | 50 Years | All | 91 | Phase 2 | Canada;France;Italy;Portugal;United Kingdom |
| 4 | EUCTR2016-005230-30-GB (EUCTR) | 14/07/2017 | 03/05/2017 | A research study to find out if SPX-101 helps people with Cystic Fibrosis and to find out if it is safe. | A Randomized, Double-Blind, Placebo-Controlled Phase II Study to Evaluate the Efficacy and Safety of SPX-101 Inhalation Solution in Subjects with Cystic Fibrosis (HOPE-1 STUDY: HYDRATION FOR OPTIMAL PULMONARY EFFECTIVENESS) - HOPE-1 Study: Hydration for Optimal Pulmonary Effectiveness | Cystic Fibrosis MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Product Name: SPX-101 INN or Proposed INN: SPX-101 Product Name: SPX-101 INN or Proposed INN: SPX-101 | Spyryx Biosciences, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 90 | Phase 2 | Portugal;France;Canada;Australia;Italy;United Kingdom | ||
| 5 | NCT03056989 (ClinicalTrials.gov) | May 31, 2017 | 15/2/2017 | A Safety Study of SPX-101 Inhalation Solution in Subjects With Cystic Fibrosis | A Phase 1, Single-Center, Open-Label Safety Study of SPX-101 Inhalation Solution in Subjects With Cystic Fibrosis | Cystic Fibrosis | Drug: SPX-101 | Spyryx Biosciences, Inc. | NULL | Completed | 18 Years | 50 Years | All | 5 | Phase 1 | Canada |