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	NCT02609048 (ClinicalTrials.gov)	November 2015	13/11/2015	Study to Evaluate the Effects of Two Doses of MBX-8025 in Subjects With Primary Biliary Cirrhosis (PBC)	A 12-week, Double-blind, Randomized, Placebo-controlled, Phase 2 Study, to Evaluate the Effects of Two Doses of MBX-8025 in Subjects With Primary Biliary Cirrhosis (PBC) and an Inadequate Response to Ursodeoxycholic Acid (UDCA)	Primary Biliary Cirrhosis (PBC)	Drug: Placebo Comparator;Drug: Experimental: Seladelpar / MBX-8025 50 mg;Drug: Experimental: Seladelpar / MBX-8025 200 mg	CymaBay Therapeutics, Inc.	NULL	Terminated	18 Years	75 Years	All	41	Phase 2	United States;Canada;Germany;Poland;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

NCT02609048
(ClinicalTrials.gov)

November 2015

13/11/2015

Study to Evaluate the Effects of Two Doses of MBX-8025 in Subjects With Primary Biliary Cirrhosis (PBC)

A 12-week, Double-blind, Randomized, Placebo-controlled, Phase 2 Study, to Evaluate the Effects of Two Doses of MBX-8025 in Subjects With Primary Biliary Cirrhosis (PBC) and an Inadequate Response to Ursodeoxycholic Acid (UDCA)

Primary Biliary Cirrhosis (PBC)

Drug: Placebo Comparator;Drug: Experimental: Seladelpar / MBX-8025 50 mg;Drug: Experimental: Seladelpar / MBX-8025 200 mg

CymaBay Therapeutics, Inc.

NULL

Terminated

18 Years

75 Years

All

Phase 2

United States;Canada;Germany;Poland;United Kingdom