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3

93. 原発性胆汁性胆管炎


臨床試験数 : 298 薬物数 : 252 - (DrugBank : 59) / 標的遺伝子数 : 35 - 標的パスウェイ数 : 115
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1EUCTR2015-001590-41-PL
(EUCTR)
09/02/201705/01/2017A multi-part, double blind study to assess safety, tolerability and efficacy of tropifexor (LJN452) in PBC patientsA 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 AGNULLNot RecruitingFemale: yes
Male: yes
152Phase 2United States;Canada;Poland;Russian Federation;Germany;China;United Kingdom
2EUCTR2015-001590-41-DE
(EUCTR)
11/01/201613/01/2016A multi-part, double blind study to assess safety, tolerability and efficacy of tropifexor (LJN452) in PBC patientsA 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 AGNULLNot RecruitingFemale: yes
Male: yes
152Phase 2United States;Canada;Poland;Russian Federation;Germany;China;United Kingdom
3NCT02516605
(ClinicalTrials.gov)
September 9, 20154/8/2015A Multi-part, Double Blind Study to Assess Safety, Tolerability and Efficacy of Tropifexor (LJN452) in PBC PatientsA Multi-part, Randomized, Double-blind, Placebo-controlled Study to Assess the Safety, Tolerability and Efficacy of Tropifexor (LJN452) in Patients With Primary Biliary CholangitisPrimary Biliary CholangitisDrug: Part 1: LJN452;Drug: Part 1: Placebo;Drug: Part 2: LJN452 Dose level 1;Drug: Part 2: Placebo;Drug: Part 2: LJN452 Dose level 2Novartis PharmaceuticalsNULLCompleted18 YearsN/AAll61Phase 2United States;Canada;Germany;Poland;Russian Federation;United Kingdom