Gkt137831 (DrugBank: -)
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 | 1 |
| 93 | 原発性胆汁性胆管炎［原発性胆汁性肝硬変 (~2017.3)］ | 6 |
| 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 | NCT03865927 (ClinicalTrials.gov) | September 7, 2020 | 1/3/2019 | GKT137831 in IPF Patients With Idiopathic Pulmonary Fibrosis | A Randomized, Double-Blind, Placebo-Controlled Phase II Clinical Trial of GKT137831 in Patients With Idiopathic Pulmonary Fibrosis | Idiopathic Pulmonary Fibrosis | Other: Placebo Oral Tablet;Drug: GKT137831 | University of Alabama at Birmingham | NULL | Recruiting | 40 Years | 85 Years | All | 60 | Phase 2 | 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 | EUCTR2016-004599-23-GR (EUCTR) | 27/10/2017 | 06/07/2017 | A study assessing the efficacy and safety of GKT137831 in Patients with Primary Biliary Cholangitis Receiving Ursodeoxycholic Acid and with Persistently Elevated Alkaline Phosphatase | A Double-Blind, Randomized, Placebo-Controlled Clinical Trial to Assess the Efficacy and Safety of Oral GKT137831 in Patients with Primary Biliary Cholangitis Receiving Ursodeoxycholic Acid and with Persistently Elevated Alkaline Phosphatase | Primary Biliary Cholangitis MedDRA version: 20.0;Level: LLT;Classification code 10036680;Term: Primary biliary cirrhosis;System Organ Class: 100000023866 ;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Genkyotex SA | NULL | Not Recruiting | Female: yes Male: yes | 102 | Phase 2 | United States;Canada;Greece;Belgium;Spain;Israel;Germany;Italy;United Kingdom | |||
| 2 | EUCTR2016-004599-23-DE (EUCTR) | 19/09/2017 | 10/07/2017 | A study assessing the efficacy and safety of GKT137831 in Patients with Primary Biliary Cholangitis Receiving Ursodeoxycholic Acid and with Persistently Elevated Alkaline Phosphatase | A Double-Blind, Randomized, Placebo-Controlled Clinical Trial to Assess the Efficacy and Safety of Oral GKT137831 in Patients with Primary Biliary Cholangitis Receiving Ursodeoxycholic Acid and with Persistently Elevated Alkaline Phosphatase | Primary Biliary Cholangitis MedDRA version: 20.1;Level: LLT;Classification code 10036680;Term: Primary biliary cirrhosis;System Organ Class: 100000004871 ;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Genkyotex SA | NULL | Not Recruiting | Female: yes Male: yes | 102 | Phase 2 | United States;Greece;Canada;Belgium;Spain;Israel;Germany;Italy;United Kingdom | |||
| 3 | EUCTR2016-004599-23-BE (EUCTR) | 10/08/2017 | 10/04/2017 | A study assessing the efficacy and safety of GKT137831 in Patients with Primary Biliary Cholangitis Receiving Ursodeoxycholic Acid and with Persistently Elevated Alkaline Phosphatase | A Double-Blind, Randomized, Placebo-Controlled Clinical Trial to Assess the Efficacy and Safety of Oral GKT137831 in Patients with Primary Biliary Cholangitis Receiving Ursodeoxycholic Acid and with Persistently Elevated Alkaline Phosphatase | Primary Biliary Cholangitis MedDRA version: 20.1;Level: LLT;Classification code 10036680;Term: Primary biliary cirrhosis;System Organ Class: 100000004871;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Code: GKT137831 INN or Proposed INN: GKT137831 Other descriptive name: GKT137831 | Genkyotex SA | NULL | Not Recruiting | Female: yes Male: yes | 102 | Phase 2 | United States;Greece;Canada;Spain;Belgium;Israel;Germany;Italy;United Kingdom | ||
| 4 | EUCTR2016-004599-23-ES (EUCTR) | 26/07/2017 | 04/07/2017 | A study assessing the efficacy and safety of GKT137831 in Patients with Primary Biliary Cholangitis Receiving Ursodeoxycholic Acid and with Persistently Elevated Alkaline Phosphatase | A Double-Blind, Randomized, Placebo-Controlled Clinical Trial to Assess the Efficacy and Safety of Oral GKT137831 in Patients with Primary Biliary Cholangitis Receiving Ursodeoxycholic Acid and with Persistently Elevated Alkaline Phosphatase | Primary Biliary Cholangitis MedDRA version: 20.0;Level: LLT;Classification code 10036680;Term: Primary biliary cirrhosis;System Organ Class: 100000023866;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Code: GKT137831 INN or Proposed INN: GKT137831 Other descriptive name: GKT137831 | Genkyotex SA | NULL | Not Recruiting | Female: yes Male: yes | 102 | Phase 2 | United States;Greece;Canada;Belgium;Spain;Israel;Germany;Italy;United Kingdom | ||
| 5 | EUCTR2016-004599-23-GB (EUCTR) | 30/06/2017 | 17/05/2017 | A study assessing the efficacy and safety of GKT137831 in Patients with Primary Biliary Cholangitis Receiving Ursodeoxycholic Acid and with Persistently Elevated Alkaline Phosphatase | A Double-Blind, Randomized, Placebo-Controlled Clinical Trial to Assess the Efficacy and Safety of Oral GKT137831 in Patients with Primary Biliary Cholangitis Receiving Ursodeoxycholic Acid and with Persistently Elevated Alkaline Phosphatase | Primary Biliary Cholangitis MedDRA version: 20.1;Level: LLT;Classification code 10036680;Term: Primary biliary cirrhosis;System Organ Class: 100000004871 ;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Genkyotex SA | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 102 | Phase 2 | United States;Greece;Canada;Belgium;Spain;Israel;Germany;Italy;United Kingdom | |||
| 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 | NCT03226067 (ClinicalTrials.gov) | June 26, 2017 | 30/6/2017 | Study to Assess Safety and Efficacy of GKT137831 in Patients With Primary Biliary Cholangitis Receiving Ursodeoxycholic Acid. | A Double-Blind, Randomized, Placebo-Controlled Clinical Trial to Assess the Efficacy and Safety of Oral GKT137831 in Patients With Primary Biliary Cholangitis Receiving Ursodeoxycholic Acid and With Persistently Elevated Alkaline Phosphatase | Primary Biliary Cirrhosis | Drug: GKT137831;Drug: Placebo oral capsule | Genkyotex SA | NULL | Completed | 18 Years | 80 Years | All | 111 | Phase 2 | United States;Belgium;Canada;Germany;Greece;Israel;Italy;Spain;United Kingdom |