SB12 (proposed eculizumab biosimilar) ( DrugBank: Eculizumab )
1 disease
| 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 |
62. 発作性夜間ヘモグロビン尿症
臨床試験数 : 271 / 薬物数 : 163 - (DrugBank : 49) / 標的遺伝子数 : 22 - 標的パスウェイ数 : 106
| 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 | Completed | 18 Years | N/A | All | 50 | Phase 3 | India;Korea, Republic of;Malaysia;Mexico;Romania;Taiwan;Thailand;Ukraine |