OCTA-C1-INH ( DrugBank: C1-INH )


1 disease
告示番号疾患名(ページ内リンク)臨床試験数
65原発性免疫不全症候群1

65. 原発性免疫不全症候群


臨床試験数 : 500 薬物数 : 614 - (DrugBank : 119) / 標的遺伝子数 : 92 - 標的パスウェイ数 : 217
No.TrialIDDate_
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Public_titleScientific_titleConditionInterventionPrimary_
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agemin
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agemax
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PhaseCountries
1EUCTR2019-001693-28-DE
(EUCTR)
06/02/202002/09/2019Single-arm pharmacokinetic phase 2a study of a single dose intravenous human plasma-derived C1-INH involving 20 HAE type I or type II patients, aged 18 years or olderProspective, open-label, single arm, multicenter, pharmacokinetic, and safety study of a single dose intravenous human plasma-derived C1 Esterase Inhibitor (C1-INH) concentrate in patients with congenital C1-INH deficiency and hereditary angioedema - CONE-01 Hereditary angioedema type I and type II
MedDRA version: 20.0;Level: PT;Classification code 10019860;Term: Hereditary angioedema;System Organ Class: 10010331 - Congenital, familial and genetic disorders
MedDRA version: 21.0;Level: LLT;Classification code 10080956;Term: Hereditary angioedema type I;Classification code 10080960;Term: Hereditary angioedema type II;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Body processes [G] - Immune system processes [G12]
Product Name: C1 Esterase Inhibitor Human
Product Code: OCTA-C1-INH
Other descriptive name: C1 ESTERASE INHIBITOR (HUMAN)
Octapharma Pharmazeutika Produktionsges.m.b.H.NULLNot RecruitingFemale: yes
Male: yes
20Phase 2Czech Republic;Russian Federation;Hungary;Ukraine;Poland;Belarus;Bulgaria;Serbia;Germany