ACT-HIB Polvere e solvente per soluzione iniettabile in siringa preriempita 0,5 ml ( DrugBank: - )
2 diseases
| 告示番号 | 疾患名（ページ内リンク） | 臨床試験数 |
|---|---|---|
| 61 | 自己免疫性溶血性貧血 | 1 |
| 62 | 発作性夜間ヘモグロビン尿症 | 2 |
61. 自己免疫性溶血性貧血
臨床試験数 : 146 / 薬物数 : 131 - (DrugBank : 59) / 標的遺伝子数 : 28 - 標的パスウェイ数 : 158
| 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 | EUCTR2021-002039-40-IT (EUCTR) | 08/02/2022 | 01/10/2021 | Basket study to assess efficacy, safety and PK of iptacopan (LNP023) in autoimmune benign hematological disorders | An open-label, multi-center, phase 2 basket study to assess efficacy, safety and pharmacokinetics of iptacopan (LNP023) in participants with autoimmune benign hematological disorders - -- | Immune thrombocytopenia (ITP)Cold agglutinin disease (CAD) MedDRA version: 23.0;Level: PT;Classification code 10083842;Term: Immune thrombocytopenia;System Organ Class: 10005329 - Blood and lymphatic system disorders MedDRA version: 20.0;Level: LLT;Classification code 10068863;Term: Cold agglutinin disease;System Organ Class: 10005329 - Blood and lymphatic system disorders;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15] | Trade Name: ACT-HIB Polvere e solvente per soluzione iniettabile in siringa preriempita 0,5 ml Product Name: - Product Code: [-] INN or Proposed INN: HAEMOPHILUS INFLUENZAE Trade Name: BEXSERO – Sospensione iniettabile – Siringa preriempita Product Name: - Product Code: [-] INN or Proposed INN: VACCINO CONTRO IL MEMINGOCOCCO DI GRUPPO B Trade Name: HIBERIX - POLVERE E SOLVENTE PER SOLUZIONE INIETTABILE PER USO INTRAMUSCOLARE 1 FLACONCINO DI POLVERE + 1 SIRINGA PRERIEMPITA DI SOLVENTE DA 0.5 ML Product Name: - Product Code: [-] INN or Proposed INN: VACCINO HAEMOPHILUS INFLUENZAE B CONIUGATO CON TOSSOIDETETANICO Trade Name: MENVEO – Polvere e soluzione per soluzione iniettabile Product Name: - Product Code: [-] INN or Proposed INN: VACCINO POLISACCARIDICO ANTI-MENINGOCOCCICO (A.C.Y E W-135) Trade Name: Nimenrix Product Name: - Product Code: [-] INN or Proposed INN: VACCINO POLISACCARIDICO ANTI-MENINGOCOCCICO (A.C.Y E W-135) | NOVARTIS PHARMA AG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 30 | Phase 2 | United States;Spain;Korea, Democratic People's Republic of;Germany;United Kingdom;Italy |
62. 発作性夜間ヘモグロビン尿症
臨床試験数 : 292 / 薬物数 : 151 - (DrugBank : 49) / 標的遺伝子数 : 22 - 標的パスウェイ数 : 108
| 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 | EUCTR2020-003172-41-IT (EUCTR) | 20/07/2021 | 17/08/2021 | Study of Efficacy and Safety of Twice Daily Oral LNP023 in Adult PNH Patients who are naïve to complement inhibitor therapy. | A multicenter, single-arm, open-label trial to evaluate efficacy and safety of oral, twice daily iptacopan in adult PNH patients who are naive to complement inhibitor therapy. - - | Paroxysmal Nocturnal Hemoglobinuria (PNH). MedDRA version: 21.1;Level: PT;Classification code 10034042;Term: Paroxysmal nocturnal haemoglobinuria;System Organ Class: 10038359 - Renal and urinary disorders;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15] | Trade Name: HIBERIX - POLVERE E SOLVENTE PER SOLUZIONE INIETTABILE PER USO INTRAMUSCOLARE 1 FLACONCINO DI POLVERE + 1 SIRINGA PRERIEMPITA DI SOLVENTE DA 0.5 ML Product Name: - Product Code: [-] INN or Proposed INN: VACCINO HAEMOPHILUS INFLUENZAE B CONIUGATO CON TOSSOIDETETANICO Trade Name: MENVEO – Polvere e soluzione per soluzione iniettabile Product Name: - Product Code: [-] INN or Proposed INN: VACCINO POLISACCARIDICO ANTI-MENINGOCOCCICO (A.C.Y E W-135) Trade Name: PNEUMOVAX – Soluzione iniettabile in siringa preriempita da 0,5 ml Product Name: - Product Code: [-] INN or Proposed INN: VACCINO PNEUMOCOCCICO Trade Name: BEXSERO – Sospensione iniettabile – Siringa preriempita Product Name: - Product Code: [-] INN or Proposed INN: VACCINO CONTRO IL MEMINGOCOCCO DI GRUPPO B Trade Name: ACT-HIB Polvere e solvente per soluzione iniettabile in siringa preriempita 0,5 ml Product Name: - Product Code: [-] INN or Proposed INN: HAEMOPHILUS INFLUENZAE | NOVARTIS PHARMA AG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 40 | Phase 3 | France;United States;Czechia;Malaysia;Singapore;Germany;United Kingdom;Japan;China;Italy;Korea, Republic of | ||
| 2 | EUCTR2019-004665-40-IT (EUCTR) | 23/12/2020 | 15/06/2021 | Study of efficacy and safety of twice daily oral LNP023 in adult PNH patients with residual anemia despite anti-C5 antibody treatment | A randomized, multicenter, active-comparator controlled, open-label trial to evaluate efficacy and safety of oral, twice daily LNP023 in adult patients with PNH and residual anemia, despite treatment with an intravenous anti-C5 antibody - Study of efficacy and safety of twice daily oral LNP023 in adult PNH patients with residual anemia d | Paroxysmal Nocturnal Hemoglobinuria (PNH) MedDRA version: 21.1;Level: PT;Classification code 10034042;Term: Paroxysmal nocturnal haemoglobinuria;System Organ Class: 10038359 - Renal and urinary disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Iptacopan Product Code: [LNP023] INN or Proposed INN: Iptacopan Other descriptive name: LNP023 HYDROCHLORIDE SALT Product Name: Iptacopan Product Code: [LNP023] INN or Proposed INN: Iptacopan Other descriptive name: LNP023 HYDROCHLORIDE SALT Trade Name: Soliris Product Name: Eculizumab Product Code: [-] INN or Proposed INN: ECULIZUMAB Trade Name: ACT-HIB Polvere e solvente per soluzione iniettabile in siringa preriempita 0,5 ml Product Name: - Product Code: [-] INN or Proposed INN: HAEMOPHILUS INFLUENZAE Trade Name: MENVEO – Polvere e soluzione per soluzione iniettabile Product Name: - Product Code: [-] INN or Proposed INN: VACCINO POLISACCARIDICO ANTI-MENINGOCOCCICO (A.C.Y E W-135) Trade Name: PNEUMOVAX – Soluzione iniettabile in siringa preriempita da 0,5 ml Product Name: - Product Code: [-] INN or Proposed INN: VACCINO PNEUMOCOCCICO | NOVARTIS PHARMA AG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 91 | Phase 3 | United States;Czechia;Taiwan;Spain;Korea, Democratic People's Republic of;Italy;United Kingdom;France;Hungary;Canada;Brazil;Germany;Netherlands;Japan |