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 |
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | EUCTR2009-014842-28-PL (EUCTR) | 21/01/2010 | 02/10/2009 | A 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 GmbH | NULL | Not Recruiting | Female: yes Male: yes | 69 | Phase Ib/2a | Belgium;Poland;Ukraine;Russian Federation;Germany | ||
| 2 | EUCTR2009-014842-28-DE (EUCTR) | 14/01/2010 | 21/09/2009 | A 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 GmbH | NULL | Not Recruiting | Female: yes Male: yes | 69 | Phase Ib/2a | Belgium;Poland;Ukraine;Russian Federation;Germany |