26. HTLV-1関連脊髄症 HTLV-1-associated myelopathy Clinical trials / Disease details
臨床試験数 : 29 / 薬物数 : 47 - (DrugBank : 29) / 標的遺伝子数 : 34 - 標的パスウェイ数 : 119
| 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 | JPRN-JMA-IIA00324 | 29/06/2017 | 23/01/2018 | A Phase 3 Study of KW-0761 (Mogamulizumab) in Subjects with HTLV-1 Associated Myelopathy (HAM) | A Phase 3 Multicenter, Randomized, Double-Blind and Placebo-Controlled Study, and Open Study of KW-0761 in Subjects with HTLV-1 Associated Myelopathy (HAM) | HTLV-1 associated Myelopathy (HAM) | Intervention type:DRUG. Intervention1:KW-0761, Dose form:INJECTION, Route of administration:INTRAVENOUS DRIP. Control intervention1:Placebo, Dose form:INJECTION, Route of administration:INTRAVENOUS DRIP. | Kyowa Kirin Co., Ltd | NULL | Completed | >=20 YEARS | No Limit | BOTH | 52 | Phase 3 | Japan |
| 2 | JPRN-JapicCTI-173608 | 15/6/2017 | 06/06/2017 | A Phase 3 Study of KW-0761 in Subjects with HTLV-1 Associated Myelopathy (HAM) | A Phase 3 Multicenter, Randomized, Double-Blind and Placebo-Controlled Study, and Open Study of KW-0761 in Subjects with HTLV-1 Associated Myelopathy (HAM) | HTLV-1 associated Myelopathy (HAM) | Intervention name : KW-0761 INN of the intervention : Mogamulizumab Dosage And administration of the intervention : 0.3 mg/kg, IV Control intervention name : - INN of the control intervention : - Dosage And administration of the control intervention : - | Kyowa Kirin Co., Ltd. | NULL | complete | 20 | BOTH | 52 | Phase 3 | Japan | |
| 3 | JPRN-UMIN000016683 | 2015/03/13 | 05/03/2015 | Novel autologous dendritic cell vaccine therapy targeting HTLV-1 specific antigen Combined with anti-CCR4 antibody for previously treated patients with adult T-cell leukemia. A phase Ia/Ib study. | Novel autologous dendritic cell vaccine therapy targeting HTLV-1 specific antigen Combined with anti-CCR4 antibody for previously treated patients with adult T-cell leukemia. A phase Ia/Ib study. - Phase Ia/Ib study of Tax-targeting DC vaccine combined with anti-CCR4 Ab for ATL | Adult T-cell leukemia/lymphoma | Tax-targeting DC vaccine KW-0761 (Mogamulizumab) | Japan Agency for Medical Research and Development | National Hospital Organization Kyushu Cancer Center | Complete: follow-up continuing | 20years-old | 75years-old | Male and Female | 9 | Phase 1 | Japan |