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	NCT03112681 (ClinicalTrials.gov)	August 18, 2017	10/4/2017	Study to Evaluate Safety, Tolerability and Efficacy of Saroglitazar Mg in Patients With Primary Biliary Cholangitis	A Phase 2, Prospective, Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate Safety, Tolerability and Efficacy of Saroglitazar Magnesium in Patients With Primary Biliary Cholangitis (EPICS )	Primary Biliary Cirrhosis	Drug: Saroglitazar magnesium 2 mg;Drug: Saroglitazar magnesium 4 mg;Drug: Placebo Oral Tablet	Zydus Discovery DMCC	NULL	Active, not recruiting	18 Years	75 Years	All	37	Phase 2	United States

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

NCT03112681
(ClinicalTrials.gov)

August 18, 2017

10/4/2017

Study to Evaluate Safety, Tolerability and Efficacy of Saroglitazar Mg in Patients With Primary Biliary Cholangitis

A Phase 2, Prospective, Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate Safety, Tolerability and Efficacy of Saroglitazar Magnesium in Patients With Primary Biliary Cholangitis (EPICS )

Primary Biliary Cirrhosis

Drug: Saroglitazar magnesium 2 mg;Drug: Saroglitazar magnesium 4 mg;Drug: Placebo Oral Tablet

Zydus Discovery DMCC

NULL

Active, not recruiting

18 Years

75 Years

All

Phase 2

United States