GSK1550188 (Belimumab) ( DrugBank: Belimumab )


1 disease
告示番号疾患名(ページ内リンク)臨床試験数
222一次性ネフローゼ症候群4

222. 一次性ネフローゼ症候群


臨床試験数 : 310 薬物数 : 295 - (DrugBank : 117) / 標的遺伝子数 : 63 - 標的パスウェイ数 : 194
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1EUCTR2011-000242-38-CZ
(EUCTR)
14/02/201313/11/2012A 2 year study to investigate belimumab in membranous nephropathyBEL114674: A 2 year study of efficacy and safety of intravenous belimumab versus placebo in subjects with idiopathic membranous nephropathy - GSK1550188 in membranous nephropathy Idiopathic Membranous Nephropathy (IMN)
MedDRA version: 14.1;Level: SOC;Classification code 10038359;Term: Renal and urinary disorders;System Organ Class: 10038359 - Renal and urinary disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Trade Name: BENLYSTA®
Product Name: BENLYSTA®
Product Code: GSK1550188 (Belimumab)
INN or Proposed INN: BELIMUMAB
GlaxoSmithKline Research & Development LtdNULLNot RecruitingFemale: yes
Male: yes
94United States;France;Czech Republic;Canada;Spain;Australia;Netherlands;Germany;United Kingdom;Italy
2EUCTR2011-000242-38-DE
(EUCTR)
09/01/201325/09/2012A 2 year study to investigate belimumab in membranous nephropathyBEL114674: A 2 year study of efficacy and safety ofintravenous belimumab versus placebo in subjects withidiopathic membranous nephropathy - GSK1550188 in membranous nephropathy Idiopathic Membranous Nephropathy (IMN)
MedDRA version: 16.0;Level: LLT;Classification code 10027170;Term: Membranous nephropathy;System Organ Class: 100000004857;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Trade Name: BENLYSTA®
Product Name: BENLYSTA®
Product Code: GSK1550188 (Belimumab)
INN or Proposed INN: BELIMUMAB
GlaxoSmithKline Research & Development LtdNULLNot RecruitingFemale: yes
Male: yes
94France;United States;Czech Republic;Canada;Spain;Australia;Netherlands;Germany;Italy;United Kingdom
3EUCTR2011-000242-38-ES
(EUCTR)
20/12/201222/10/2012A 2 year study to investigate belimumab in membranous nephropathyA 2 year study of efficacy and safety ofintravenous belimumab versus placebo in subjects withidiopathic membranous nephropathy - GSK1550188 in membranous nephropathy Idiopathic Membranous Nephropathy (IMN)
MedDRA version: 14.1;Level: LLT;Classification code 10027170;Term: Membranous nephropathy;System Organ Class: 100000004857;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Trade Name: BENLYSTA®
Product Name: BENLYSTA®
Product Code: GSK1550188 (Belimumab)
INN or Proposed INN: BELIMUMAB
GlaxoSmithKline, S.A.NULLNot RecruitingFemale: yes
Male: yes
94United States;France;Czech Republic;Canada;Spain;Netherlands;Germany;United Kingdom;Italy
4EUCTR2011-000242-38-GB
(EUCTR)
01/11/201203/10/2012 A 2 year study to investigate belimumab in membranous nephropathy BEL114674: A 2 year study of efficacy and safety of intravenous belimumab versus placebo in subjects with idiopathic membranous nephropathy - GSK1550188 in membranous nephropathy Idiopathic Membranous Nephropathy (IMN)
MedDRA version: 15.0;Level: LLT;Classification code 10027170;Term: Membranous nephropathy;System Organ Class: 10038359 - Renal and urinary disorders ;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Trade Name: BENLYSTA®
Product Name: BENLYSTA®
Product Code: GSK1550188 (Belimumab)
INN or Proposed INN: BELIMUMAB
GlaxoSmithKline Research & Development LtdNULLNot Recruiting Female: yes
Male: yes
94 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): noFrance;United States;Czech Republic;Canada;Spain;Netherlands;Germany;Italy;United Kingdom