AMG531 ( DrugBank: - )
2 diseases
| 告示番号 | 疾患名（ページ内リンク） | 臨床試験数 |
|---|---|---|
| 60 | 再生不良性貧血 | 7 |
| 63 | 特発性血小板減少性紫斑病 | 2 |
60. 再生不良性貧血
臨床試験数 : 245 / 薬物数 : 318 - (DrugBank : 86) / 標的遺伝子数 : 44 - 標的パスウェイ数 : 166
| 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 | NCT04095936 (ClinicalTrials.gov) | December 3, 2019 | 18/9/2019 | Study of AMG531 (Romiplostim) in Patients With Aplastic Anemia | A Phase 2/3 Study of AMG531 Combined With Ciclosporin A in Patients With Aplastic Anemia Previously Untreated With Immunosuppressive Therapy | Aplastic Anemia | Drug: Romiplostim | Kyowa Kirin Co., Ltd. | NULL | Completed | 20 Years | N/A | All | 24 | Phase 2/Phase 3 | Japan |
| 2 | JPRN-JapicCTI-194962 | 03/12/2019 | 18/09/2019 | A Phase 2/3 Study of AMG531 in Patients with Aplastic Anemia | A Phase 2/3 Study of AMG531 Combined with Ciclosporin A in Patients with Aplastic Anemia Previously Untreated with Immunosuppressive Therapy | Aplastic Anemia | Intervention name : AMG531 INN of the intervention : romiplostim Dosage And administration of the intervention : SC-administered Control intervention name : - INN of the control intervention : - Dosage And administration of the control intervention : - | Kyowa Kirin Co., Ltd | NULL | complete | 20 | BOTH | 24 | Phase 2-3 | Japan, Asia except Japan | |
| 3 | NCT03957694 (ClinicalTrials.gov) | April 25, 2019 | 9/5/2019 | Study of AMG531(Romiplostim) in Patients With Aplastic Anemia | A Phase 2/3 Study of AMG531 in Patients With Aplastic Anemia PreviouslyUntreated With Immunosuppressive Therapy | Aplastic Anemia | Drug: Romiplostim | Kyowa Kirin Co., Ltd. | NULL | Completed | 20 Years | N/A | All | 17 | Phase 2/Phase 3 | Japan |
| 4 | JPRN-JapicCTI-194746 | 01/2/2019 | 09/05/2019 | A Phase 2/3 Study of AMG531 in Patients with Aplastic Anemia | A Phase 2/3 Study of AMG531 in Patients with Aplastic Anemia Previously Untreated with Immunosuppressive Therapy | Aplastic Anemia | Intervention name : AMG531 INN of the intervention : romiplostim Dosage And administration of the intervention : SC-administered Control intervention name : - INN of the control intervention : - Dosage And administration of the control intervention : - | Kyowa Kirin Co., Ltd | NULL | complete | 20 | BOTH | 14 | Phase 2-3 | Japan, Asia except Japan | |
| 5 | NCT02773290 (ClinicalTrials.gov) | May 2016 | 9/5/2016 | Study of Romiplostim(AMG531) in Subjects With Aplastic Anemia | Phase 2/3 Study of Romiplostim(AMG531) in Subjects With Aplastic Anemia Refractory to or Ineligible for Immunosuppressive Therapy | Aplastic Anemia | Biological: Romiplostim | Kyowa Kirin Co., Ltd. | NULL | Completed | 20 Years | N/A | All | 46 | Phase 2/Phase 3 | Japan;Korea, Republic of |
| 6 | JPRN-JapicCTI-163243 | 01/2/2016 | 02/05/2016 | Phase 2/3 Study of AMG531 in Subjects with Aplastic Anemia | Phase 2/3 Study of AMG531 in Subjects with Aplastic Anemia Refractory to or Ineligible for Immunosuppressive Therapy | Aplastic Anemia | Intervention name : AMG531 INN of the intervention : Romiplostim Dosage And administration of the intervention : Subcutaneous administration | Kyowa Hakko Kirin Co., Ltd. | NULL | complete | 20 | BOTH | 46 | Phase 2-3 | NULL | |
| 7 | NCT02094417 (ClinicalTrials.gov) | April 14, 2014 | 18/3/2014 | A Phase 2 Study to Evaluate the Efficacy and Safety of AMG531 in Aplastic Anemia | A Phase 2, Randomized, Open-Label, Parallel, Comparative, Dose-Finding Study to Evaluate the Efficacy and Safety of AMG531 in Aplastic Anemia Subjects With Thrombocytopenia Refractory to Immunosuppressive Therapy | Aplastic Anemia | Drug: AMG531 | Kyowa Kirin Korea Co., Ltd. | NULL | Completed | 19 Years | N/A | All | 35 | Phase 2 | Korea, Republic of |
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. | 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 | EUCTR2004-000172-13-IT (EUCTR) | 22/07/2008 | 10/07/2008 | AN OPEN LABEL STUDY EVALUATING THE SAFETY AND EFFICACY OF LONG-TERM DOSING OF AMG 531 IN THROMBOCYTOPENIC SUBJECTS WITH IMMUNE (IDIOPATHIC) THROMBOCITOPENIC PURPURA | AN OPEN LABEL STUDY EVALUATING THE SAFETY AND EFFICACY OF LONG-TERM DOSING OF AMG 531 IN THROMBOCYTOPENIC SUBJECTS WITH IMMUNE (IDIOPATHIC) THROMBOCITOPENIC PURPURA | Thrombocytopenia in subjects with ITP 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] - Blood and lymphatic diseases [C15] | Product Name: AMG531 Product Code: AMG531 INN or Proposed INN: AMG531 | AMGEN S.P.A. | NULL | Not Recruiting | Female: yes Male: yes | 350 | Czech Republic;Belgium;Austria;Germany;United Kingdom;Italy | |||
| 2 | EUCTR2007-000638-37-IT (EUCTR) | 09/06/2008 | 04/08/2008 | An open label study of AMG531 in severely refractory thrombocytopenic subjects with immune (idiopathic) Thrombocytopenic Purpura (ITP) - AMG 531 20040209 | An open label study of AMG531 in severely refractory thrombocytopenic subjects with immune (idiopathic) Thrombocytopenic Purpura (ITP) - AMG 531 20040209 | Thrombocytopenia in subjects with ITP MedDRA version: 9.1;Level: LLT;Classification code 10021245;Term: Idiopathic thrombocytopenic purpura | Product Name: AMG531 Product Code: AMG531 | AMGEN S.P.A. | NULL | Not Recruiting | Female: yes Male: yes | 100 | United Kingdom;Czech Republic;Netherlands;Belgium;Spain;Ireland;Italy;Austria |