Gs-6624 (DrugBank: GS-6624)
2 diseases| 告示番号 | 疾患名（ページ内リンク） | 臨床試験数 |
|---|---|---|
| 85 | 特発性間質性肺炎 | 10 |
| 94 | 原発性硬化性胆管炎 | 9 |
| 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 | EUCTR2012-001571-36-PL (EUCTR) | 09/09/2013 | 17/06/2013 | A study to evaluate if a new drug is effective in preventing the progression of lung fibrosis | A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Multi-Center Study to Assess the Efficacy and Safety of GS-6624 in Subjects with Idiopathic Pulmonary Fibrosis (RAINIER) - RAINIER | Idiopathic pulmonary fibrosis MedDRA version: 18.1;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Product Code: GS-6624 INN or Proposed INN: Simtuzumab Other descriptive name: GS-6624 | Gilead Sciences, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 500 | Phase 2 | United States;Czech Republic;Canada;Spain;Belgium;Poland;Australia;Israel;Germany;United Kingdom;Italy;Korea, Republic of | ||
| 2 | EUCTR2012-001571-36-DE (EUCTR) | 17/06/2013 | 02/04/2013 | A study to evaluate if a new drug is effective in preventing the progression of lung fibrosis | A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Multi-Center Study to Assess the Efficacy and Safety of GS-6624 in Subjects with Idiopathic Pulmonary Fibrosis (RAINIER). - RAINIER | Idiopathic pulmonary fibrosis MedDRA version: 18.0;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Product Code: GS-6624 INN or Proposed INN: Simtuzumab Other descriptive name: GS-6624 | Gilead Sciences, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 500 | Phase 2 | United States;Czech Republic;Canada;Poland;Spain;Belgium;Australia;Israel;Germany;United Kingdom;Italy;Korea, Republic of | ||
| 3 | EUCTR2012-001571-36-BE (EUCTR) | 28/05/2013 | 26/03/2013 | A study to evaluate if a new drug is effective in preventing the progression of lung fibrosis | A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Multi-Center Study to Assess the Efficacy and Safety of GS-6624 in Subjects with Idiopathic Pulmonary Fibrosis (RAINIER) - RAINIER | Idiopathic pulmonary fibrosis MedDRA version: 18.1;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Product Code: GS-6624 INN or Proposed INN: Simtuzumab Other descriptive name: GS-6624 | Gilead Sciences, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 500 | Phase 2 | Korea, Democratic People's Republic of;Israel;United Kingdom;Switzerland;Italy;France;Czech Republic;Canada;Belgium;Poland;Australia;Germany;Korea, Republic of;United States;Spain | ||
| 4 | EUCTR2012-001571-36-ES (EUCTR) | 12/05/2013 | 16/05/2013 | A study to evaluate if a new drug is effective in preventing the progression of lung fibrosis | A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Multi-Center Study to Assess the Efficacy and Safety of GS-6624 in Subjects with Idiopathic Pulmonary Fibrosis (RAINIER) - RAINER | Idiopathic pulmonary fibrosis MedDRA version: 16.0;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Product Code: GS-6624 INN or Proposed INN: Simtuzumab Other descriptive name: GS-6624 | Gilead Sciences, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 500 | Phase 2 | United States;Czech Republic;Canada;Poland;Belgium;Spain;Australia;Israel;Germany;United Kingdom;Italy;Korea, Republic of | ||
| 5 | EUCTR2012-001571-36-CZ (EUCTR) | 29/04/2013 | 15/04/2013 | A study to evaluate if a new drug is effective in preventing the progression of lung fibrosis | A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Multi-Center Study to Assess the Efficacy and Safety of GS-6624 in Subjects with Idiopathic Pulmonary Fibrosis (RAINIER). - RAINIER | Idiopathic pulmonary fibrosis MedDRA version: 18.1;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Product Code: GS-6624 INN or Proposed INN: Simtuzumab Other descriptive name: GS-6624 | Gilead Sciences, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 500 | Phase 2 | United States;Czech Republic;Canada;Poland;Spain;Belgium;Australia;Israel;Germany;United Kingdom;Italy;Korea, Republic of | ||
| 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 |
| 6 | EUCTR2012-001571-36-IT (EUCTR) | 26/04/2013 | 28/02/2013 | A study to evaluate if a new drug is effective in preventing the progression of lung fibrosis | A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Multi-Center Study to Assess the Efficacy and Safety of GS-6624 in Subjects with Idiopathic Pulmonary Fibrosis (RAINIER) - RAINIER | Idiopathic pulmonary fibrosis MedDRA version: 14.1;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Product Code: GS-6624 INN or Proposed INN: Simtuzumab Other descriptive name: GS-6624 | Gilead Sciences, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 500 | Phase 2 | United States;Czech Republic;Canada;Poland;Spain;Belgium;Australia;Israel;Germany;United Kingdom;Italy;Korea, Republic of | ||
| 7 | EUCTR2012-001571-36-GB (EUCTR) | 19/04/2013 | 28/03/2013 | A study to evaluate if a new drug is effective in preventing the progression of lung fibrosis | A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Multi-Center Study to Assess the Efficacy and Safety of GS-6624 in Subjects with Idiopathic Pulmonary Fibrosis (RAINIER) - RAINIER | Idiopathic pulmonary fibrosis MedDRA version: 17.0;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Product Code: GS-6624 INN or Proposed INN: Simtuzumab Other descriptive name: GS-6624 | Gilead Sciences, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 500 | Phase 2 | United States;Czech Republic;Canada;Poland;Spain;Belgium;Australia;Israel;Germany;Italy;United Kingdom;Korea, Republic of | ||
| 8 | NCT01769196 (ClinicalTrials.gov) | January 31, 2013 | 14/1/2013 | Study to Assess the Efficacy and Safety of Simtuzumab (GS-6624) in Adults With Idiopathic Pulmonary Fibrosis (IPF) | A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Multi-Center Study to Assess the Efficacy and Safety of Simtuzumab (GS-6624) in Subjects With Idiopathic Pulmonary Fibrosis (IPF) | Idiopathic Pulmonary Fibrosis | Drug: Simtuzumab;Drug: Simtuzumab placebo | Gilead Sciences | NULL | Terminated | 45 Years | 85 Years | All | 544 | Phase 2 | United States;Australia;Belgium;Canada;Czechia;France;Germany;Israel;Italy;Korea, Republic of;Poland;Spain;Switzerland;United Kingdom;Czech Republic |
| 9 | NCT01759511 (ClinicalTrials.gov) | October 18, 2012 | 15/11/2012 | Long-Term Safety Study of GS-6624 in Adults With Idiopathic Pulmonary Fibrosis (IPF) | A Phase 2, Long-Term Safety Study of GS-6624 in Adult Subjects With Idiopathic Pulmonary Fibrosis (IPF) | Idiopathic Pulmonary Fibrosis | Drug: Simtuzumab | Gilead Sciences | NULL | Terminated | 18 Years | N/A | All | 34 | Phase 2 | United States |
| 10 | NCT01362231 (ClinicalTrials.gov) | December 2010 | 12/4/2011 | A Study to Evaluate the Safety and Efficacy of GS-6624 (Formerly AB0024) in Patients With Idiopathic Pulmonary Fibrosis | A Phase 1 Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of GS-6624 in Adult Subjects With Idiopathic Pulmonary Fibrosis | Idiopathic Pulmonary Fibrosis | Drug: GS-6624 | Gilead Sciences | NULL | Completed | 40 Years | 85 Years | Both | 48 | Phase 1 | United States |
| 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 | EUCTR2012-002473-61-BE (EUCTR) | 16/12/2013 | 02/09/2013 | An investigational study to assess the safety and efficacy of a new investigational drug in subjects with primary sclerosing cholangitis (PSC) | A Phase 2b, Dose-Ranging, Randomized, Double-Blind, Placebo-Controlled Trial Evaluating the Safety and Efficacy of GS-6624, a Monoclonal Antibody Against Lysyl Oxidase Like 2 (LOXL2) in Subjects with Primary Sclerosing Cholangitis (PSC) | Primary Sclerosing Cholangitis (PSC) MedDRA version: 18.0;Level: LLT;Classification code 10036732;Term: Primary sclerosing cholangitis;System Organ Class: 100000004871;Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18] | Product Code: GS-6624 INN or Proposed INN: GS-6624 INN or Proposed INN: GS-6624 | Gilead Sciences Inc | NULL | Not Recruiting | Female: yes Male: yes | 225 | Phase 2 | France;United States;Canada;Spain;Belgium;Denmark;Norway;Netherlands;Germany;Italy;United Kingdom;Sweden | ||
| 2 | EUCTR2012-002473-61-NL (EUCTR) | 12/12/2013 | 04/10/2013 | An investigational study to assess the safety and efficacy of a new investigational drug in subjects with primary sclerosing cholangitis (PSC) | A Phase 2b, Dose-Ranging, Randomized, Double-Blind, Placebo-Controlled Trial Evaluating the Safety and Efficacy of GS-6624, a Monoclonal Antibody Against Lysyl Oxidase Like 2 (LOXL2) in Subjects with Primary Sclerosing Cholangitis (PSC) | Primary Sclerosing Cholangitis (PSC) MedDRA version: 18.1;Level: LLT;Classification code 10036732;Term: Primary sclerosing cholangitis;System Organ Class: 100000004871;Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18] | Product Code: GS-6624 INN or Proposed INN: GS-6624 INN or Proposed INN: GS-6624 | Gilead Sciences Inc | NULL | Not Recruiting | Female: yes Male: yes | 225 | Phase 2 | France;United States;Canada;Belgium;Spain;Denmark;Germany;Netherlands;Italy;United Kingdom;Sweden | ||
| 3 | EUCTR2012-002473-61-SE (EUCTR) | 26/06/2013 | 20/03/2013 | An investigational study to assess the safety and efficacy of a new investigational drug in subjects with primary sclerosing cholangitis (PSC) | A Phase 2b, Dose-Ranging, Randomized, Double-Blind, Placebo-Controlled Trial Evaluating the Safety and Efficacy of GS-6624, a Monoclonal Antibody Against Lysyl Oxidase Like 2 (LOXL2) in Subjects with Primary Sclerosing Cholangitis (PSC) | Primary Sclerosing Cholangitis (PSC) MedDRA version: 18.0;Level: LLT;Classification code 10036732;Term: Primary sclerosing cholangitis;System Organ Class: 100000004871;Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18] | Product Code: GS-6624 INN or Proposed INN: GS-6624 INN or Proposed INN: GS-6624 | Gilead Sciences Inc | NULL | Not Recruiting | Female: yes Male: yes | 225 | Phase 2 | United States;Canada;Belgium;Spain;Denmark;Netherlands;Italy;United Kingdom;Sweden | ||
| 4 | EUCTR2012-002473-61-ES (EUCTR) | 21/06/2013 | 09/04/2013 | An investigational study to assess the safety and efficacy of a new investigational drug in subjects with primary sclerosing cholangitis (PSC) | A Phase 2b, Dose-Ranging, Randomized, Double-Blind, Placebo-Controlled Trial Evaluating the Safety and Efficacy of GS-6624, a Monoclonal Antibody Against Lysyl Oxidase Like 2 (LOXL2) in Subjects with Primary Sclerosing Cholangitis (PSC) | Primary Sclerosing Cholangitis (PSC) MedDRA version: 14.1;Level: LLT;Classification code 10036732;Term: Primary sclerosing cholangitis;System Organ Class: 100000004871;Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18] | Product Code: GS-6624 INN or Proposed INN: GS-6624 INN or Proposed INN: GS-6624 | Gilead Sciences Inc | NULL | Not Recruiting | Female: yes Male: yes | 225 | Phase 2 | United States;Canada;Belgium;Spain;Denmark;Netherlands;Italy;United Kingdom;Sweden | ||
| 5 | EUCTR2012-002473-61-IT (EUCTR) | 18/06/2013 | 04/04/2013 | An investigational study to assess the safety and efficacy of a new investigational drug in subjects with primary sclerosing cholangitis (PSC) | A Phase 2b, Dose-Ranging, Randomized, Double-Blind, Placebo-Controlled Trial Evaluating the Safety and Efficacy of GS-6624, a Monoclonal Antibody Against Lysyl Oxidase Like 2 (LOXL2) in Subjects with Primary Sclerosing Cholangitis (PSC) | Primary Sclerosing Cholangitis (PSC) MedDRA version: 14.1;Level: LLT;Classification code 10036732;Term: Primary sclerosing cholangitis;System Organ Class: 100000004871;Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18] | Product Name: Simtuzumab Product Code: GS-6624 INN or Proposed INN: Simtuzimab Product Name: Simtuzimab Product Code: GS-6624 INN or Proposed INN: Simtuzimab | Gilead Sciences Inc | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 225 | Phase 2b | United States;Canada;Denmark;United Kingdom;Italy;Sweden | ||
| 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 |
| 6 | EUCTR2012-002473-61-GB (EUCTR) | 17/05/2013 | 13/03/2013 | An investigational study to assess the safety and efficacy of a new investigational drug in subjects with primary sclerosing cholangitis (PSC) | A Phase 2b, Dose-Ranging, Randomized, Double-Blind, Placebo-Controlled Trial Evaluating the Safety and Efficacy of GS-6624, a Monoclonal Antibody Against Lysyl Oxidase Like 2 (LOXL2) in Subjects with Primary Sclerosing Cholangitis (PSC) | Primary Sclerosing Cholangitis (PSC) MedDRA version: 17.0;Level: LLT;Classification code 10036732;Term: Primary sclerosing cholangitis;System Organ Class: 100000004871 ;Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18] | Gilead Sciences Inc | NULL | Not Recruiting | Female: yes Male: yes | 225 | Phase 2 | France;United States;Canada;Belgium;Spain;Denmark;Netherlands;Germany;Italy;United Kingdom;Sweden | |||
| 7 | EUCTR2012-002473-61-DK (EUCTR) | 14/05/2013 | 08/04/2013 | An investigational study to assess the safety and efficacy of a new investigational drug in subjects with primary sclerosing cholangitis (PSC) | A Phase 2b, Dose-Ranging, Randomized, Double-Blind, Placebo-Controlled Trial Evaluating the Safety and Efficacy of GS-6624, a Monoclonal Antibody Against Lysyl Oxidase Like 2 (LOXL2) in Subjects with Primary Sclerosing Cholangitis (PSC) | Primary Sclerosing Cholangitis (PSC) MedDRA version: 17.0;Level: LLT;Classification code 10036732;Term: Primary sclerosing cholangitis;System Organ Class: 100000004871;Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18] | Product Code: GS-6624 INN or Proposed INN: GS-6624 INN or Proposed INN: GS-6624 | Gilead Sciences Inc | NULL | Not Recruiting | Female: yes Male: yes | 225 | Phase 2 | United States;Canada;Belgium;Spain;Denmark;Netherlands;Italy;United Kingdom;Sweden | ||
| 8 | EUCTR2012-002473-61-DE (EUCTR) | 08/05/2013 | 08/03/2013 | An investigational study to assess the safety and efficacy of a new investigational drug in subjects with primary sclerosing cholangitis (PSC) | A Phase 2b, Dose-Ranging, Randomized, Double-Blind, Placebo-Controlled Trial Evaluating the Safety and Efficacy of GS-6624, a Monoclonal Antibody Against Lysyl Oxidase Like 2 (LOXL2) in Subjects with Primary Sclerosing Cholangitis (PSC) | Primary Sclerosing Cholangitis (PSC) MedDRA version: 17.0;Level: LLT;Classification code 10036732;Term: Primary sclerosing cholangitis;System Organ Class: 100000004871;Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18] | Product Code: GS-6624 INN or Proposed INN: GS-6624 INN or Proposed INN: GS-6624 | Gilead Sciences Inc | NULL | Not Recruiting | Female: yes Male: yes | 225 | Phase 2 | France;United States;Canada;Belgium;Spain;Denmark;Netherlands;Germany;Italy;United Kingdom;Sweden | ||
| 9 | NCT01672853 (ClinicalTrials.gov) | March 4, 2013 | 22/8/2012 | Simtuzumab (GS-6624) in the Prevention of Progression of Liver Fibrosis in Adults With Primary Sclerosing Cholangitis (PSC) | A Phase 2b, Dose-Ranging, Randomized, Double-Blind, Placebo-Controlled Trial Evaluating the Safety and Efficacy of GS-6624, a Monoclonal Antibody Against Lysyl Oxidase Like 2 (LOXL2) in Subjects With Primary Sclerosing Cholangitis (PSC) | Primary Sclerosing Cholangitis (PSC) | Biological: Simtuzumab;Biological: Placebo | Gilead Sciences | NULL | Completed | 18 Years | 70 Years | All | 235 | Phase 2 | United States;Belgium;Canada;Denmark;Germany;Italy;Netherlands;Spain;Sweden;United Kingdom |