DDrare: Database of Drug Development for Rare Diseases

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)］	1

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	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

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

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

Phase 2

United States;Canada;Germany;Poland;Russian Federation;United Kingdom