Ljn452 (DrugBank: -)
1 disease| 告示番号 | 疾患名（ページ内リンク） | 臨床試験数 |
|---|---|---|
| 93 | 原発性胆汁性胆管炎［原発性胆汁性肝硬変 (~2017.3)］ | 3 |
| 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 | EUCTR2015-001590-41-PL (EUCTR) | 09/02/2017 | 05/01/2017 | A multi-part, double blind study to assess safety, tolerability and efficacy of tropifexor (LJN452) in PBC patients | A multi-part, randomized, double-blind, placebo-controlled study to assess the safety, tolerability and efficacy of tropifexor (LJN452) in patients with primary biliary cholangitis - Multi-part, double blind study to assess safety, tolerability and efficacy of LJN452 in PBC patients | primary biliary cholangitis MedDRA version: 20.1;Level: LLT;Classification code 10036680;Term: Primary biliary cirrhosis;System Organ Class: 100000004871;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Code: LJN452 INN or Proposed INN: tropifexor Other descriptive name: LJN452 Product Code: LJN452 INN or Proposed INN: tropifexor Other descriptive name: LJN452 Product Code: LJN452 INN or Proposed INN: tropifexor Other descriptive name: LJN452 | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 152 | Phase 2 | United States;Canada;Poland;Russian Federation;Germany;China;United Kingdom | ||
| 2 | EUCTR2015-001590-41-DE (EUCTR) | 11/01/2016 | 13/01/2016 | A multi-part, double blind study to assess safety, tolerability and efficacy of tropifexor (LJN452) in PBC patients | A multi-part, randomized, double-blind, placebo-controlled study to assess the safety, tolerability and efficacy of tropifexor (LJN452) in patients with primary biliary cholangitis - Multi-part, double blind study to assess safety, tolerability and efficacy of LJN452 in PBC patients | primary biliary cholangitis MedDRA version: 20.1;Level: LLT;Classification code 10036680;Term: Primary biliary cirrhosis;System Organ Class: 100000004871;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Code: LJN452, 0,01 mg INN or Proposed INN: tropifexor Other descriptive name: LJN452 Product Code: LJN452, 0,03 mg INN or Proposed INN: tropifexor Other descriptive name: LJN452 Product Code: LJN452, 0,1 mg INN or Proposed INN: tropifexor Other descriptive name: LJN452 | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 152 | Phase 2 | United States;Canada;Poland;Russian Federation;Germany;China;United Kingdom | ||
| 3 | NCT02516605 (ClinicalTrials.gov) | September 9, 2015 | 4/8/2015 | A Multi-part, Double Blind Study to Assess Safety, Tolerability and Efficacy of Tropifexor (LJN452) in PBC Patients | A Multi-part, Randomized, Double-blind, Placebo-controlled Study to Assess the Safety, Tolerability and Efficacy of Tropifexor (LJN452) in Patients With Primary Biliary Cholangitis | Primary Biliary Cholangitis | Drug: Part 1: LJN452;Drug: Part 1: Placebo;Drug: Part 2: LJN452 Dose level 1;Drug: Part 2: Placebo;Drug: Part 2: LJN452 Dose level 2 | Novartis Pharmaceuticals | NULL | Completed | 18 Years | N/A | All | 61 | Phase 2 | United States;Canada;Germany;Poland;Russian Federation;United Kingdom |