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	NCT01389973 (ClinicalTrials.gov)	September 2011	7/7/2011	A Study of Efficacy and Safety of Ustekinumab in Patients With Primary Biliary Cirrhosis (PBC) Who Had an Inadequate Response to Ursodeoxycholic Acid	A Phase 2, Multi-center, Randomized, Double-blind, Placebo-controlled, Parallel-group Study Evaluating the Efficacy and Safety of Ustekinumab in Subjects With Primary Biliary Cirrhosis Who Had an Inadequate Response to Ursodeoxycholic Acid (UDCA)	Primary Biliary Cirrhosis	Drug: ustekinumab 90 mg;Drug: ustekinumab 45 mg;Drug: ustekinumab 180 mg;Drug: Placebo	Janssen Research & Development, LLC	NULL	Completed	18 Years	99 Years	All	20	Phase 2	United States;Canada

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

NCT01389973
(ClinicalTrials.gov)

September 2011

7/7/2011

A Study of Efficacy and Safety of Ustekinumab in Patients With Primary Biliary Cirrhosis (PBC) Who Had an Inadequate Response to Ursodeoxycholic Acid

A Phase 2, Multi-center, Randomized, Double-blind, Placebo-controlled, Parallel-group Study Evaluating the Efficacy and Safety of Ustekinumab in Subjects With Primary Biliary Cirrhosis Who Had an Inadequate Response to Ursodeoxycholic Acid (UDCA)

Primary Biliary Cirrhosis

Drug: ustekinumab 90 mg;Drug: ustekinumab 45 mg;Drug: ustekinumab 180 mg;Drug: Placebo

Janssen Research & Development, LLC

NULL

Completed

18 Years

99 Years

All

Phase 2

United States;Canada