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	NCT02955602 (ClinicalTrials.gov)	November 28, 2016	2/11/2016	Seladelpar (MBX-8025) in Subjects With Primary Biliary Cholangitis (PBC)	An 8-week, Dose Ranging, Open Label, Randomized, Phase 2 Study With a 44-week Extension, to Evaluate the Safety and Efficacy of MBX-8025 in Subjects With Primary Biliary Cholangitis (PBC) and an Inadequate Response to or Intolerance to Ursodeoxycholic Acid (UDCA)	Primary Biliary Cirrhosis	Drug: MBX-8025 2 mg Capsule;Drug: MBX-8025 5 mg Capsule;Drug: MBX-8025 10 mg Capsule	CymaBay Therapeutics, Inc.	NULL	Completed	18 Years	75 Years	All	119	Phase 2	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

NCT02955602
(ClinicalTrials.gov)

November 28, 2016

2/11/2016

Seladelpar (MBX-8025) in Subjects With Primary Biliary Cholangitis (PBC)

An 8-week, Dose Ranging, Open Label, Randomized, Phase 2 Study With a 44-week Extension, to Evaluate the Safety and Efficacy of MBX-8025 in Subjects With Primary Biliary Cholangitis (PBC) and an Inadequate Response to or Intolerance to Ursodeoxycholic Acid (UDCA)

Primary Biliary Cirrhosis

Drug: MBX-8025 2 mg Capsule;Drug: MBX-8025 5 mg Capsule;Drug: MBX-8025 10 mg Capsule

CymaBay Therapeutics, Inc.

NULL

Completed

18 Years

75 Years

All

119

Phase 2

United States;Canada;Germany;United Kingdom