Octaplas (DrugBank: -)
1 disease| 告示番号 | 疾患名（ページ内リンク） | 臨床試験数 |
|---|---|---|
| 64 | 血栓性血小板減少性紫斑病 | 4 |
| 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 | EUCTR2017-000858-18-AT (EUCTR) | 20/03/2018 | 05/12/2017 | A Phase 3, randomized, controlled study of severe congenital thrombotic thrombocytopenic purpura, with Bax 930. | A phase 3, prospective, randomized, controlled, open-label, multicenter, 2-period crossover study with a single arm continuation evaluating the safety and efficacy of BAX 930 (rADAMTS13) in the prophylactic and on-demand treatment of subjects with severe congenital thrombotic thrombocytopenic purpura (cTTP, Upshaw-Schulman Syndrome [USS], hereditary thrombotic thrombocytopenic purpura [hTTP]) - A phase 3, randomized, controlled study of prophylactic and on-demand treatment of cTTP with BAX 930 | severe congenital thrombotic thrombocytopenic purpura(cTTP, Upshaw-Schulman Syndrome [USS], hereditary thromboticthrombocytopenic purpura [hTTP]) MedDRA version: 20.0;Level: LLT;Classification code 10043562;Term: Thrombocytopenic purpura, thrombotic;System Organ Class: 100000004851;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15] | Product Name: Recombinant A Disintegrin and Metalloproteinase with Thrombospondin Type-1 Motifs 13 Product Code: BAX930 or SHP655 INN or Proposed INN: apadamtase alfa Other descriptive name: Recombinant A Disintegrin and Metalloproteinase with Thrombospondin Type-1 Motifs Trade Name: Octaplas SD Product Name: Octaplas®LG INN or Proposed INN: Octaplas Other descriptive name: Pooled Plasma (Human), Solvent/Detergent Treated Product Name: Recombinant A Disintegrin and Metalloproteinase with Thrombospondin Type-1 Motifs 13 Product Code: BAX930 or SHP655 INN or Proposed INN: apademtase alfa Other descriptive name: Recombinant A Disintegrin and Metalloproteinase with Thrombospondin Type-1 | Baxalta Innovations GmbH | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 68 | Phase 3 | United States;France;Canada;Poland;Spain;Austria;Germany;United Kingdom;Switzerland;Japan;Italy | ||
| 2 | NCT03369314 (ClinicalTrials.gov) | March 2, 2018 | 30/11/2017 | Observational Study of the Use of octaplasLG®. | Observational, Real-life Study of the Use of octaplasLG®. | Thrombotic Thrombocytopenic Purpura | Drug: octaplasLG® | Octapharma | NULL | Recruiting | N/A | N/A | All | 100 | France;New Caledonia | |
| 3 | NCT01938404 (ClinicalTrials.gov) | June 6, 2017 | 2/9/2013 | Octaplas Adult TTP Trial | Post-Marketing Requirement Study to Evaluate the Safety and Efficacy of Octaplas™ in Patients With Thrombotic Thrombocytopenic Purpura With Special Emphasis on Monitoring the Occurrence of Thromboembolic Events | Thrombotic Thrombocytopenic Purpura | Biological: Octaplas;Drug: Standard Plasma | Octapharma | NULL | Terminated | 18 Years | N/A | All | 1 | United States | |
| 4 | NCT01754545 (ClinicalTrials.gov) | September 2012 | 12/12/2012 | Prophylactic Plasma Infusion Therapy for Congenital Thrombotic Thrombocytopenic Purpura | Prophylactic Plasma Infusion Therapy for Congenital Thrombotic Thrombocytopenic Purpura | Purpura, Thrombotic Thrombocytopenic | Drug: Octaplas infusion and placebo (group 1);Drug: Octaplas infusion and placebo (group 2) | St. Olavs Hospital | Norwegian University of Science and Technology | Withdrawn | 18 Years | 65 Years | Both | 0 | Phase 4 | Norway |