GC1008 ( DrugBank: GC1008 )


2 diseases
告示番号疾患名(ページ内リンク)臨床試験数
85特発性間質性肺炎1
222一次性ネフローゼ症候群4

85. 特発性間質性肺炎


臨床試験数 : 627 薬物数 : 443 - (DrugBank : 120) / 標的遺伝子数 : 99 - 標的パスウェイ数 : 212
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1NCT00125385
(ClinicalTrials.gov)
July 200529/7/2005Study of GC1008 in Patients With Idiopathic Pulmonary Fibrosis (IPF)Phase I, Open-Label, Multi-Center, Single-Dose, Dose-Escalating, Safety, Tolerability and Pharmacokinetic of GC1008 in Patients With Idiopathic Pulmonary FibrosisIdiopathic Pulmonary FibrosisBiological: GC1008Genzyme, a Sanofi CompanyNULLCompleted18 Years79 YearsBoth25Phase 1United States;Belgium

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
1EUCTR2012-002365-35-DE
(EUCTR)
15/07/201311/03/2013A Study of Fresolimumab in Patients With Steroid-Resistant Primary Focal Segmental Glomerulosclerosis (FSGS)A Phase 2, Multicenter, Double-Blind, Parallel Dosing, Randomized Study of Fresolimumab or Placebo in Patients with Steroid-Resistant Primary Focal Segmental Glomerulosclerosis Focal segmental glomerulosclerosis
MedDRA version: 14.1;Level: PT;Classification code 10067757;Term: Focal segmental glomerulosclerosis;System Organ Class: 10038359 - Renal and urinary disorders;Therapeutic area: Not possible to specify
Product Name: Fresolimumab
Product Code: GC1008
INN or Proposed INN: Fresolimumab
Other descriptive name: GZ402669
Genzyme CorporationNULLNot RecruitingFemale: yes
Male: yes
125Phase 2France;United States;Brazil;Spain;Germany;Italy
2EUCTR2012-002365-35-IT
(EUCTR)
22/05/201320/03/2013A Study of Fresolimumab in Patients With Steroid-Resistant Primary Focal Segmental Glomerulosclerosis (FSGS)A Phase 2, Multicenter, Double-Blind, Parallel Dosing, Randomized Study of Fresolimumab or Placebo in Patients with Steroid-Resistant Primary Focal Segmental Glomerulosclerosis Focal segmental glomerulosclerosis
MedDRA version: 15.1;Level: PT;Classification code 10067757;Term: Focal segmental glomerulosclerosis;System Organ Class: 10038359 - Renal and urinary disorders;Therapeutic area: Not possible to specify
Product Name: Fresolimumab
Product Code: GC1008
INN or Proposed INN: Fresolimumab
Other descriptive name: GZ402669
Genzyme CorporationNULLNot RecruitingFemale: yes
Male: yes
125Phase 2France;United States;Brazil;Spain;Germany;Italy
3EUCTR2012-002365-35-ES
(EUCTR)
19/04/201309/04/2013A Study of Fresolimumab in Patients With Steroid-Resistant Primary Focal Segmental Glomerulosclerosis (FSGS)A Phase 2, Multicenter, Double-Blind, Parallel Dosing, Randomized Study of Fresolimumab or Placebo in Patients with Steroid-Resistant Primary Focal Segmental Glomerulosclerosis Focal segmental glomerulosclerosis
MedDRA version: 14.1;Level: PT;Classification code 10067757;Term: Focal segmental glomerulosclerosis;System Organ Class: 10038359 - Renal and urinary disorders;Therapeutic area: Not possible to specify
Product Name: Fresolimumab
Product Code: GC1008
INN or Proposed INN: Fresolimumab
Other descriptive name: GZ402669
Genzyme CorporationNULLNot RecruitingFemale: yes
Male: yes
125Phase 2France;United States;Brazil;Spain;Germany;Italy
4NCT00464321
(ClinicalTrials.gov)
May 200720/4/2007Safety Study of GC1008 in Patients With Focal Segmental Glomerulosclerosis (FSGS) of Single Doses of GC1008 in Patients With Treatment Resistant Idiopathic FSGSA Phase I, Multicentre, Open-label, Dose-escalating Study of Single Doses of GC1008 in Patients With Treatment Resistant Idiopathic Focal Segmental Glomerulosclerosis (FSGS)Focal Segmental GlomerulosclerosisBiological: GC1008Genzyme, a Sanofi CompanyNULLCompleted18 YearsN/ABoth16Phase 1United States;Germany;Italy;United Kingdom