SM101 5mg/mL ( DrugBank: - )


1 disease
告示番号疾患名(ページ内リンク)臨床試験数
63特発性血小板減少性紫斑病2

63. 特発性血小板減少性紫斑病


臨床試験数 : 391 薬物数 : 235 - (DrugBank : 50) / 標的遺伝子数 : 49 - 標的パスウェイ数 : 139
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
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size
PhaseCountries
1EUCTR2009-014842-28-PL
(EUCTR)
21/01/201002/10/2009A study to assess the safety and effectiveness of the study drug(SM101) versus placebo( dummy treatment)in adult patients with chronic Primary Immune Thrombocytopenia(ITP)A Randomised, Multi-centre, Double-Blind, Placebo-Controlled, Single/Multiple Dose Escalation Phase Ib/IIa Clinical Trial to Investigate the Safety and Efficacy of Recombinant Human Soluble Fc-gamma Receptor IIb (SM101) for Intravenous Application in the Treatment of Patients with Chronic Adult Primary Immune Thrombocytopenia (ITP). Primary Immune Thrombocytopenia
MedDRA version: 15.1;Level: PT;Classification code 10021245;Term: Idiopathic thrombocytopenic purpura;System Organ Class: 10005329 - Blood and lymphatic system disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: SM101 20mg/mL
Product Code: SM101
INN or Proposed INN: SM101
Product Name: SM101 5mg/mL
Product Code: SM101
INN or Proposed INN: SM101
SuppreMol GmbHNULLNot RecruitingFemale: yes
Male: yes
69Phase 1Belgium;Poland;Ukraine;Russian Federation;Germany
2EUCTR2009-014842-28-DE
(EUCTR)
14/01/201021/09/2009A study to assess the safety and effectiveness of the study drug (SM101) versus a placebo (dummy treatment) in adult patients with chronic Primary Immune Thrombocytopenia (ITP).A Randomised, Multi-centre, Double-Blind, Placebo-Controlled, Single/Multiple Dose Escalation Phase Ib/IIa Clinical Trial to Investigate the Safety and Efficacy of Recombinant Human Soluble Fc-gamma Receptor IIb (SM101) for Intravenous Application in the Treatment of Patients with Chronic Adult Primary Immune Thrombocytopenia (ITP). Primary Immune Thrombocytopenia
MedDRA version: 14.1;Level: PT;Classification code 10021245;Term: Idiopathic thrombocytopenic purpura;System Organ Class: 10005329 - Blood and lymphatic system disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: SM101 20mg/mL
Product Code: SM101
INN or Proposed INN: SM101
Product Name: SM101 5mg/mL
Product Code: SM101
INN or Proposed INN: SM101
SuppreMol GmbHNULLNot RecruitingFemale: yes
Male: yes
69Phase 1Belgium;Poland;Ukraine;Russian Federation;Germany