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Clinical trial

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

NCT04058158 is registered in ClinicalTrials.gov with Samsung Bioepis Co., Ltd. as lead sponsor.

NCT NCT04058158
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Registry record

As filed in ClinicalTrials.gov.

Title
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
Lead sponsor
Samsung Bioepis Co., Ltd.
Phase
Phase 3
Overall status
Completed
Start date
August 7, 2019
Completion date
October 21, 2021
Enrollment
50 (actual)
Sites
27

Conditions

As the registry lists them; a condition with its own page is linked.

paroxysmal nocturnal hemoglobinuria