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	NCT03301506 (ClinicalTrials.gov)	December 12, 2017	26/9/2017	Seladelpar in Subjects With Primary Biliary Cholangitis (PBC)	ASSURE: An Open Label Long-Term Study to Evaluate the Safety and Tolerability of Seladelpar in Subjects With Primary Biliary Cholangitis (PBC)	Primary Biliary Cirrhosis	Drug: Seladelpar 5 mg Capsule;Drug: Seladelpar 10 mg Capsule	CymaBay Therapeutics, Inc.	NULL	Active, not recruiting	18 Years	75 Years	All	500	Phase 3	United States;Canada;Germany;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

December 12, 2017

26/9/2017

Seladelpar in Subjects With Primary Biliary Cholangitis (PBC)

ASSURE: An Open Label Long-Term Study to Evaluate the Safety and Tolerability of Seladelpar in Subjects With Primary Biliary Cholangitis (PBC)

Primary Biliary Cirrhosis

Drug: Seladelpar 5 mg Capsule;Drug: Seladelpar 10 mg Capsule

CymaBay Therapeutics, Inc.

NULL

Active, not recruiting

18 Years

75 Years

All

500

Phase 3

United States;Canada;Germany;United Kingdom