65. 原発性免疫不全症候群 Primary immunodeficiency Clinical trials / Disease details
臨床試験数 : 500 / 薬物数 : 614 - (DrugBank : 119) / 標的遺伝子数 : 92 - 標的パスウェイ数 : 217
| 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 | NCT05513586 (ClinicalTrials.gov) | September 13, 2022 | 22/8/2022 | A Study to Evaluate the Long-term Safety of TAK-771 in Japanese Primary Immunodeficiency Disease (PID) Participants | A Phase 3, Open-label, Non-controlled, Extension Study to Evaluate the Long-term Safety of TAK-771 in Japanese Patients With Primary Immunodeficiency Disease (PID) | Primary Immunodeficiency Diseases (PID) | Drug: TAK-771 | Takeda | NULL | Recruiting | 2 Years | N/A | All | 10 | Phase 3 | Japan |
| 2 | JPRN-jRCT2041220059 | 24/08/2022 | 26/08/2022 | A Study to Evaluate the Long-term Safety of TAK-771 in Japanese Primary Immunodeficiency Disease (PID) Participants | A Phase 3, Open-label, Non-controlled, Extension Study to Evaluate the Long-term Safety of TAK-771 in Japanese Patients with Primary Immunodeficiency Disease (PID) | Primary Immunodeficiency Diseases (PID) | TAK-771 includes Immune Globulin Infusion (IGI) 10% and Recombinant Human Hyaluronidase (rHuPH20). Participants will receive SC infusion of rHuPH20 solution at a dose of 80 U/g IgG first, followed by SC infusion of 10% IGI within 10 minutes of completion of the infusion of rHuPH20 solution. | Nishizawa Atsushi | NULL | Pending | >= 2age old | Not applicable | Both | 10 | Phase 3 | Japan |
| 3 | JPRN-jRCT2031210457 | 24/01/2022 | 27/11/2021 | A Study of TAK-771 in Japanese People With Primary Immunodeficiency Diseases (PID) | A Phase 3, Open-label, Non-controlled Study to Evaluate the Pharmacokinetics, Safety and Tolerability, and Efficacy of TAK-771 in Japanese Subjects with Primary Immunodeficiency Diseases (PID) | Primary Immunodeficiency Diseases (PID) | Epoch 1: TAK-771 Ramp up Period TAK-771 includes Immune Globulin Infusion (IGI) 10% and Recombinant Human Hyaluronidase (rHuPH20). Participants will receive SC infusion of rHuPH20 solution at a dose of 80 U/g IgG first, followed by SC infusion of 10% IGI within 10 minutes of completion of the infusion of rHuPH20 solution. The dose of 10% IGI will be increased from 1/3 of full dose to full dose in 3 weeks for participants who will receive TAK-771 once every 3 week, or from 1/4 of full dose to full dose in 6 weeks for participants who will receive TAK-771 once every 4 week. Epoch 2: TAK-771 Treatment Period TAK-771 includes Immune Globulin Infusion (IGI) 10% and Recombinant Human Hyaluronidase (rHuPH20). Participants will receive subcutaneous infusion of rHuPH20 solution at a dose of 80 U/g IgG first, followed by SC infusion of 10% IGI within 10 minutes of completion of the infusion of rHuPH20 solution, every 3, or 4 weeks for up to Week 24. | Nishizawa Atsushi | NULL | Recruiting | >= 2age old | Not applicable | Both | 15 | Phase 3 | Japan |
| 4 | NCT05150340 (ClinicalTrials.gov) | January 24, 2022 | 24/11/2021 | A Study of TAK-771 in Japanese People With Primary Immunodeficiency Diseases (PID) | A Phase 3, Open-label, Non-controlled Study to Evaluate the Pharmacokinetics, Safety and Tolerability, and Efficacy of TAK-771 in Japanese Subjects With Primary Immunodeficiency Diseases (PID) | Primary Immunodeficiency Diseases (PID) | Drug: TAK-771 | Takeda | NULL | Active, not recruiting | 2 Years | N/A | All | 16 | Phase 3 | Japan |