Peginesatide ( DrugBank: Peginesatide )


1 disease
告示番号疾患名(ページ内リンク)臨床試験数
283後天性赤芽球癆3

283. 後天性赤芽球癆


臨床試験数 : 19 薬物数 : 36 - (DrugBank : 23) / 標的遺伝子数 : 20 - 標的パスウェイ数 : 102
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1NCT00314795
(ClinicalTrials.gov)
April 6, 200613/4/2006Efficacy and Safety of Peginesatide (AF37702) in the Treatment of Anemia in Participants With Chronic Kidney DiseaseAn Open-Label Study to Investigate the Efficacy and Safety of AF37702 Injection in the Treatment of Anemia Caused by Antibody-Mediated Pure Red Cell Aplasia in Patients With Chronic Kidney DiseaseAnemia;Chronic Kidney Disease;Chronic Renal Failure;Pure Red Cell AplasiaDrug: PeginesatideTakedaNULLCompleted18 YearsN/AAll22Phase 2France;Germany;United Kingdom
2EUCTR2005-004944-30-DE
(EUCTR)
08/03/200620/12/2005A Phase 2 study of AF37702 Injection for anemia in patients with pure red cell aplasia.An Open-Label Study to Investigate the Efficacy and Safety of AF37702 Injection (Hematide™) in the Treatment of Anemia Caused by Antibody-Mediated Pure Red Cell Aplasia in Patients with Chronic Kidney Disease - AFX01-06 Anemia caused by Antibody-Mediated Pure Red Cell Aplasia in Patients with Chronic Kidney Disease
MedDRA version: 18.0;Level: PT;Classification code 10002965;Term: Aplasia pure red cell;System Organ Class: 10005329 - Blood and lymphatic system disorders;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]
Product Name: AF37702 Injection
Product Code: AF37702, Hematide
INN or Proposed INN: peginesatide
Other descriptive name: Hematide, peginesatide
Product Name: AF37702 Injection
Product Code: AF37702, Hematide
INN or Proposed INN: peginesatide
Other descriptive name: Hematide, peginesatide
Takeda Development Centre Europe LtdNULLNot RecruitingFemale: yes
Male: yes
40Phase 2Germany;United Kingdom
3EUCTR2005-004944-30-GB
(EUCTR)
23/02/200609/12/2005A Phase 2 study of AF37702 Injection for anemia in patients with pure red cell aplasia.An Open-Label Study to Investigate the Efficacy and Safety of AF37702 Injection in the Treatment of Anemia Caused by Antibody-Mediated Pure Red Cell Aplasia in Patients with Chronic Kidney Disease - AFX01-06 Anemia caused by Antibody-Mediated Pure Red Cell Aplasia in Patients with Chronic Kidney Disease
MedDRA version: 18.0;Level: PT;Classification code 10002965;Term: Aplasia pure red cell;System Organ Class: 10005329 - Blood and lymphatic system disorders ;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]
Product Name: AF37702 Injection
Product Code: AF37702, Hematide
INN or Proposed INN: peginesatide
Other descriptive name: Hematide, peginesatide
Product Name: AF37702 Injection
Product Code: AF37702, Hematide
INN or Proposed INN: peginesatide
Other descriptive name: Hematide, peginesatide
Takeda Development Centre Europe LtdNULLNot Recruiting Female: yes
Male: yes
40 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): noGermany;United Kingdom