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
62	発作性夜間ヘモグロビン尿症	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	NCT04058158 (ClinicalTrials.gov)	August 7, 2019	12/8/2019	A Study to Compare SB12 (Proposed Eculizumab Biosimilar) to Soliris in Subjects With Paroxysmal Nocturnal Haemoglobinuria	A Phase III Randomised, Double-blind, Multicentre Study to Compare the Efficacy, Safety, Pharmacokinetics, and Immunogenicity Between SB12 (Proposed Eculizumab Biosimilar) and Soliris® in Subjects With Paroxysmal Nocturnal Haemoglobinuria	Paroxysmal Nocturnal Hemoglobinuria	Drug: SB12 (proposed eculizumab biosimilar);Drug: Soliris (eculizumab)	Samsung Bioepis Co., Ltd.	NULL	Active, not recruiting	18 Years	N/A	All	50	Phase 3	India;Korea, Republic of;Malaysia;Mexico;Romania;Taiwan;Thailand;Ukraine

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

NCT04058158
(ClinicalTrials.gov)

August 7, 2019

12/8/2019

A Study to Compare SB12 (Proposed Eculizumab Biosimilar) to Soliris in Subjects With Paroxysmal Nocturnal Haemoglobinuria

A Phase III Randomised, Double-blind, Multicentre Study to Compare the Efficacy, Safety, Pharmacokinetics, and Immunogenicity Between SB12 (Proposed Eculizumab Biosimilar) and Soliris® in Subjects With Paroxysmal Nocturnal Haemoglobinuria

Paroxysmal Nocturnal Hemoglobinuria

Drug: SB12 (proposed eculizumab biosimilar);Drug: Soliris (eculizumab)

Samsung Bioepis Co., Ltd.

NULL

Active, not recruiting

18 Years

N/A

All

Phase 3

India;Korea, Republic of;Malaysia;Mexico;Romania;Taiwan;Thailand;Ukraine