288. 自己免疫性後天性凝固因子欠乏症 Autoimmune acquired coagulation factor deficiency Clinical trials / Disease details
臨床試験数 : 205 / 薬物数 : 238 - (DrugBank : 31) / 標的遺伝子数 : 18 - 標的パスウェイ数 : 26
| 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 | NCT01968655 (ClinicalTrials.gov) | September 9, 2014 | 21/10/2013 | Expanded Access to B-Domain Deleted Recombinant Porcine Factor VIII (OBI-1) in the Treatment of Acquired Hemophilia A Due to Factor VIII Inhibitory Auto-antibodies | Expanded Access to B-Domain Deleted Recombinant Porcine Factor VIII (OBI-1) in the Treatment of Acquired Hemophilia A Due to Factor VIII Inhibitory Auto-antibodies | Acquired Hemophilia A | Biological: OBI-1 | Baxalta now part of Shire | NULL | No longer available | 18 Years | N/A | All | United States | ||
| 2 | EUCTR2011-000181-34-DE (EUCTR) | 27/06/2012 | 09/02/2012 | Study of a new factor VIII replacement for patients with acquired hemophilia A | Efficacy and Safety of B-Domain Deleted Recombinant Porcine Factor VIII (OBI-1) in the Treatment of Acquired Hemophilia A Due to Factor VIII Inhibitory Auto-antibodies | Acquired Haemophilia A MedDRA version: 16.0;Level: LLT;Classification code 10053761;Term: Acquired hemophilia with anti FVIII, XI, or XIII;System Organ Class: 100000004851;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15] | Product Name: OBI-1 Product Code: OBI-1 INN or Proposed INN: obyoctocog alfa | Baxter Innovations GmbH | NULL | Not Recruiting | Female: yes Male: yes | 28 | United States;Hungary;Canada;Germany;Italy;United Kingdom;Sweden;India | |||
| 3 | EUCTR2011-000181-34-IT (EUCTR) | 20/05/2012 | 07/08/2012 | Study of a new factor VIII replacement for patients with acquired hemophilia A | Efficacy and Satefy of B-Domain Deleted Recombinant Porcine Factor VIII (OBI-1) in the Treatment of Acquired Hemophilia A Due to Factor VIII Inhibitory Auto-antibodies - NA | Acquired Haemophilia A MedDRA version: 14.1;Level: LLT;Classification code 10053761;Term: Acquired hemophilia with anti FVIII, XI, or XIII;System Organ Class: 10005329 - Blood and lymphatic system disorders;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15] | Product Name: OBI-1 Product Code: OBI-1 Other descriptive name: recombinant porcine coagulation factor VIII (B domain deleted) | INSPIRATION BIOPHARMACEUTICALS | NULL | Not Recruiting | Female: yes Male: yes | 28 | United States;Hungary;Canada;Germany;United Kingdom;Italy;Sweden;India | |||
| 4 | EUCTR2011-000181-34-SE (EUCTR) | 10/05/2012 | 07/02/2012 | Study of a new factor VIII replacement for patients with acquired hemophilia A | Efficacy and Safety of B-Domain Deleted Recombinant Porcine Factor VIII (OBI-1) in the Treatment of Acquired Hemophilia A Due to Factor VIII Inhibitory Auto-antibodies | Acquired Haemophilia A MedDRA version: 16.0;Level: LLT;Classification code 10053761;Term: Acquired hemophilia with anti FVIII, XI, or XIII;System Organ Class: 100000004851;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15] | Product Name: OBI-1 Product Code: OBI-1 INN or Proposed INN: obyoctocog alfa | Baxter Innovations GmbH | NULL | Not Recruiting | Female: yes Male: yes | 28 | United States;Hungary;Canada;Germany;Italy;United Kingdom;India;Sweden | |||
| 5 | EUCTR2011-000181-34-HU (EUCTR) | 04/05/2012 | 15/02/2012 | Study of a new factor VIII replacement for patients with acquired hemophilia A | Efficacy and Safety of B-Domain Deleted Recombinant Porcine Factor VIII (OBI-1) in the Treatment of Acquired Hemophilia A Due to Factor VIII Inhibitory Auto-antibodies | Acquired Haemophilia A MedDRA version: 16.0;Level: LLT;Classification code 10053761;Term: Acquired hemophilia with anti FVIII, XI, or XIII;System Organ Class: 100000004851;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15] | Product Name: OBI-1 Product Code: OBI-1 INN or Proposed INN: obyoctocog alfa | Baxter Innovations GmbH | NULL | Not Recruiting | Female: yes Male: yes | 28 | United States;Hungary;Canada;Germany;Italy;United Kingdom;Sweden;India | |||
| 6 | EUCTR2011-000181-34-GB (EUCTR) | 29/06/2011 | 23/06/2011 | Study of a new factor VIII replacement for patients with acquired hemophilia A | Efficacy and Safety of B-Domain Deleted Recombinant Porcine Factor VIII (OBI-1) in the Treatment of Acquired Hemophilia A Due to Factor VIII Inhibitory Auto-antibodies | Acquired Haemophilia A MedDRA version: 14.1;Level: LLT;Classification code 10053761;Term: Acquired hemophilia with anti FVIII, XI, or XIII;System Organ Class: 100000004851;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15] | Product Name: OBI-1 Product Code: OBI-1 INN or Proposed INN: obyoctocog alfa Other descriptive name: recombinant porcine coagulation factor VIII (B-domain deleted) | Baxter Innovations GmbH | NULL | Not Recruiting | Female: yes Male: yes | 28 | United States;Hungary;Canada;Germany;Italy;United Kingdom;Sweden;India | |||
| 7 | NCT01178294 (ClinicalTrials.gov) | November 10, 2010 | 6/8/2010 | Study of Modified Recombinant Factor VIII (OBI-1) in Subjects With Acquired Hemophilia A | Efficacy and Safety of B-Domain Deleted Recombinant Porcine Factor VIII (OBI-1) in the Treatment of Acquired Hemophilia A Due to Factor VIII Inhibitory Auto-antibodies | Acquired Hemophilia A | Biological: OBI-1 | Baxalta now part of Shire | NULL | Completed | 18 Years | N/A | All | 29 | Phase 2/Phase 3 | United States;Canada;India;United Kingdom;France;Germany;Hungary;Italy;Sweden |