14. 慢性炎症性脱髄性多発神経炎／多巣性運動ニューロパチー Chronic inflammatory demyelinating polyneuropathy Clinical trials / Disease details
臨床試験数 : 167 / 薬物数 : 158 - (DrugBank : 38) / 標的遺伝子数 : 13 - 標的パスウェイ数 : 23
| 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-jRCT2051210110 | 07/12/2021 | 14/10/2021 | A Study of TAK-771 in Japanese Participants with Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP) and Multifocal Motor Neuropathy (MMN) | A Phase 3 Study to Evaluate the Efficacy, Safety and Tolerability of TAK-771 for the Treatment of Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP) and Multifocal Motor Neuropathy (MMN) in Japanese Subjects | Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP) and Multifocal Motor Neuropathy (MM | Cohort 1: TAK-771 for CIDP Participants 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 2, 3, or 4 weeks. Cohort 2: TAK-771 for MMN Participants TAK-771 includes IGI 10% and 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 2, 3, or 4 weeks. | Nishizawa Atsushi | NULL | Recruiting | >= 18age old | Not applicable | Both | 21 | Phase 3 | Japan |
| 2 | NCT02885259 (ClinicalTrials.gov) | September 2016 | 25/1/2016 | HyQvia in Multifocal Motor Neuropathy | Subcutaneous Immunoglobulin With rHuPH20 in Multifocal Motor Neuropathy | Multifocal Motor Neuropathy | Drug: rHuPH20 | UMC Utrecht | NULL | Not yet recruiting | 18 Years | 99 Years | Both | 20 | N/A | Netherlands |
| 3 | EUCTR2015-000828-28-NL (EUCTR) | 26/07/2016 | 30/11/2015 | Immunoglobulins given under the skin to treat patients with multifocal motor neuropathy (MMN). To increase the amount of immunoglobulins, an enzyme is added that will temporarily create more space under the skin. This space is filled with immunoglobulins. By this way less infusions should be needed. | Titlle: Subcutaneous immunoglobulins with rHuPH20 in multifocal motor neuropathy (MMN) It is an interventional cross-over study where the use of the combination of subcutaneous immunoglobulins together with the enzyme hyaluronidase (rHuPH20) is compared with the current gold standard intravenous immunoglobulins (IVIg). Non-inferiority and tolerability are studied in 20 MMN patients. The reason to add rHuPH20 is to increase volumes per infusion and in this way contribute to reduced frequency of infusions. - Hymne | Non-inferiority and safety/tolerance of Hyqvia compared to IVIg in 20 MMN patients with at least one conduction block on EMG and stable on IVIg.;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Hyqvia Product Name: Hyqvia | UMC Utrecht | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | Phase 3 | Netherlands |