LNP023 HYDROCHLORIDE SALT
( DrugBank: - / KEGG DRUG: - )
1 disease
| 告示番号 | 疾患名（ページ内リンク） | 臨床試験数 |
|---|---|---|
| 62 | 発作性夜間ヘモグロビン尿症 | 18 |
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
Showing 1 to 10 of 18 trials
| 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 | EUCTR2020-004385-19-NL (EUCTR) | 11/01/202220220111 | 17/11/202120211117 | Long-term safety and tolerability of iptacopan in patients with Paroxysmal Nocturnal Hemoglobinuria | An open label, multicenter roll-over extension program (REP) to characterize the long-term safety and tolerability of iptacopan (LNP023) in patients with Paroxysmal Nocturnal Hemoglobinuria (PNH) who have completed PNH Phase 2 and Phase 3 studies with iptacopan. An open label, multicenter roll-over extension program (REP) to characterize the long-term safety an ... | 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] Paroxysmal Nocturnal Hemoglobinuria (PNH) MedDRA version: 21.1;Level: PT;Classification code 1003404 ... | 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 Product Name: iptacopan Product Code: LNP023 INN or Proposed INN: iptacopan Other descriptive name: LNP ... | Novartis Pharma AG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 165 | Phase 3 | United States;Taiwan;Spain;Lithuania;Italy;France;Brazil;Malaysia;Singapore;Netherlands;China;Japan;Korea, Republic of United States;Taiwan;Spain;Lithuania;Italy;France;Brazil;Malaysia;Singapore;Netherlands;China;Japan; ... | ||
| 2 | EUCTR2020-004385-19-CZ (EUCTR) | 16/12/202120211216 | 27/07/202120210727 | Long-term safety and tolerability of iptacopan in patients with Paroxysmal Nocturnal Hemoglobinuria | An open label, multicenter roll-over extension program (REP) to characterize the long-term safety and tolerability of iptacopan (LNP023) in patients with Paroxysmal Nocturnal Hemoglobinuria (PNH) who have completed PNH Phase 2 and Phase 3 studies with iptacopan. An open label, multicenter roll-over extension program (REP) to characterize the long-term safety an ... | 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] Paroxysmal Nocturnal Hemoglobinuria (PNH) MedDRA version: 21.1;Level: PT;Classification code 1003404 ... | 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 Product Name: iptacopan Product Code: LNP023 INN or Proposed INN: iptacopan Other descriptive name: LNP ... | Novartis Pharma AG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 165 | Phase 3 | United States;Taiwan;Spain;Lithuania;Italy;France;Czech Republic;Brazil;Malaysia;Singapore;Netherlands;China;Japan;Korea, Republic of United States;Taiwan;Spain;Lithuania;Italy;France;Czech Republic;Brazil;Malaysia;Singapore;Netherlan ... | ||
| 3 | EUCTR2020-004385-19-FR (EUCTR) | 31/08/202120210831 | 15/07/202120210715 | Long-term safety and tolerability of iptacopan in patients with Paroxysmal Nocturnal Hemoglobinuria | An open label, multicenter roll-over extension program (REP) to characterize the long-term safety and tolerability of iptacopan (LNP023) in patients with Paroxysmal Nocturnal Hemoglobinuria (PNH) who have completed PNH Phase 2 and Phase 3 studies with iptacopan. An open label, multicenter roll-over extension program (REP) to characterize the long-term safety an ... | 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] Paroxysmal Nocturnal Hemoglobinuria (PNH) MedDRA version: 21.1;Level: PT;Classification code 1003404 ... | 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 Product Name: iptacopan Product Code: LNP023 INN or Proposed INN: iptacopan Other descriptive name: LNP ... | Novartis Pharma AG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 165 | Phase 3 | United States;France;Taiwan;Spain;Malaysia;Brazil;Singapore;Lithuania;Italy;Japan;China;Korea, Republic of United States;France;Taiwan;Spain;Malaysia;Brazil;Singapore;Lithuania;Italy;Japan;China;Korea, Repub ... | ||
| 4 | EUCTR2020-003172-41-CZ (EUCTR) | 12/08/202120210812 | 10/06/202120210610 | Study of Efficacy and Safety of Twice Daily Oral iptacopan in Adult PNH Patients who are naïve to complement inhibitor therapy Study of Efficacy and Safety of Twice Daily Oral iptacopan in Adult PNH Patients who are naïve to co ... | 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 A multicenter, single-arm, open-label trial to evaluate efficacy and safety of oral, twice daily ipt ... | 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] Paroxysmal Nocturnal Hemoglobinuria (PNH) MedDRA version: 21.1;Level: PT;Classification code 1003404 ... | 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 Product Name: iptacopan Product Code: LNP023 INN or Proposed INN: iptacopan Other descriptive name: LNP ... | Novartis Pharma AG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 40 | Phase 3 | France;United States;Czechia;Czech Republic;Malaysia;Singapore;Germany;United Kingdom;Italy;Japan;China;Korea, Republic of France;United States;Czechia;Czech Republic;Malaysia;Singapore;Germany;United Kingdom;Italy;Japan;Ch ... | ||
| 5 | EUCTR2020-004385-19-ES (EUCTR) | 30/07/202120210730 | 23/06/202120210623 | Long-term safety and tolerability of iptacopan in patients with Paroxysmal Nocturnal Hemoglobinuria | An open label, multicenter roll-over extension program (REP) to characterize the long-term safety and tolerability of iptacopan (LNP023) in patients with Paroxysmal Nocturnal Hemoglobinuria (PNH) who have completed PNH Phase 2 and Phase 3 studies with iptacopan. An open label, multicenter roll-over extension program (REP) to characterize the long-term safety an ... | 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] Paroxysmal Nocturnal Hemoglobinuria (PNH) MedDRA version: 21.1;Level: PT;Classification code 1003404 ... | 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 Product Name: iptacopan Product Code: LNP023 INN or Proposed INN: iptacopan Other descriptive name: LNP ... | Novartis Farmacéutica, S.A. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 165 | Phase 3 | United States;Taiwan;Malaysia;Brazil;Spain;Singapore;Japan;China;Korea, Republic of | ||
| 6 | EUCTR2020-004385-19-LT (EUCTR) | 15/07/202120210715 | 20/04/202120210420 | Long-term safety and tolerability of iptacopan in patients with Paroxysmal Nocturnal Hemoglobinuria | An open label, multicenter roll-over extension program (REP) to characterize the long-term safety and tolerability of iptacopan (LNP023) in patients with Paroxysmal Nocturnal Hemoglobinuria (PNH) who have completed PNH Phase 2 and Phase 3 studies with iptacopan. An open label, multicenter roll-over extension program (REP) to characterize the long-term safety an ... | 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] Paroxysmal Nocturnal Hemoglobinuria (PNH) MedDRA version: 21.1;Level: PT;Classification code 1003404 ... | 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 Product Name: iptacopan Product Code: LNP023 INN or Proposed INN: iptacopan Other descriptive name: LNP ... | Novartis Pharma AG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 165 | Phase 3 | United States;Taiwan;Spain;Lithuania;Italy;France;Brazil;Malaysia;Singapore;Netherlands;China;Japan;Korea, Republic of United States;Taiwan;Spain;Lithuania;Italy;France;Brazil;Malaysia;Singapore;Netherlands;China;Japan; ... | ||
| 7 | EUCTR2020-004385-19-IT (EUCTR) | 15/06/202120210615 | 08/06/202120210608 | Long-term safety and tolerability of iptacopan in patients with Paroxysmal Nocturnal Hemoglobinuria | An open label, multicenter roll-over extension program (REP) to characterize the long-term safety and tolerability of iptacopan (LNP023) in patients with Paroxysmal Nocturnal Hemoglobinuria (PNH) who have completed PNH Phase 2 and Phase 3 studies with iptacopan. - - An open label, multicenter roll-over extension program (REP) to characterize the long-term safety an ... | 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] Paroxysmal Nocturnal Hemoglobinuria (PNH) MedDRA version: 21.1;Level: PT;Classification code 1003404 ... | Trade Name: PNEUMOVAX – Soluzione iniettabile in siringa preriempita da 0,5 ml Product Name: - Product Code: [-] INN or Proposed INN: VACCINO PNEUMOCOCCICO 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: ACTHIB - POLVERE E SOLVENTE PER SOLUZIONE INIETTABILE 1 FLACONCINO POLVERE+1 SIRINGA PRERIEMPITA SOLVENTE 0.5 ML Product Name: - Product Code: [-] INN or Proposed INN: HAEMOPHILUS INFLUENZAE Trade Name: MENVEO - POLV.E SOLUZ.PER SOLUZ. INIETT.-USO INTRAMUSCOLARE-COMP. CONIUG.LIOFILIZZ.MENA:FLAC.(VETRO) COMP. GONIUG.LIQUI.MENCWY:FLAC.(VETRO)-1 FLAC+1FLAC Product Name: - Product Code: [-] INN or Proposed INN: VACCINO POLISACCARIDICO ANTI-MENINGOCOCCICO (A.C.Y E W-135) Trade Name: BEXSERO - SOSPENSIONE INIETTABILE - USO INTRAMUSCOLARE - SIRINGA P Trade Name: PNEUMOVAX – Soluzione iniettabile in siringa preriempita da 0,5 ml Product Name: - Product ... | NOVARTIS PHARMA AG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 165 | Phase 3 | United States;Taiwan;Spain;Malaysia;Brazil;Singapore;Korea, Democratic People's Republic of;Lithuania;Japan;China;Italy United States;Taiwan;Spain;Malaysia;Brazil;Singapore;Korea, Democratic People's Republic of;Lithuani ... | ||
| 8 | EUCTR2020-003172-41-FR (EUCTR) | 03/06/202120210603 | 15/04/202120210415 | Study of Efficacy and Safety of Twice Daily Oral iptacopan in Adult PNH Patients who are naïve to complement inhibitor therapy Study of Efficacy and Safety of Twice Daily Oral iptacopan in Adult PNH Patients who are naïve to co ... | 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 A multicenter, single-arm, open-label trial to evaluate efficacy and safety of oral, twice daily ipt ... | 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] Paroxysmal Nocturnal Hemoglobinuria (PNH) MedDRA version: 21.1;Level: PT;Classification code 1003404 ... | 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 Product Name: iptacopan Product Code: LNP023 INN or Proposed INN: iptacopan Other descriptive name: LNP ... | Novartis Pharma AG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 40 | Phase 3 | United States;France;Czechia;Malaysia;Singapore;Germany;United Kingdom;Italy;Japan;China;Korea, Republic of United States;France;Czechia;Malaysia;Singapore;Germany;United Kingdom;Italy;Japan;China;Korea, Repu ... | ||
| 9 | EUCTR2019-004665-40-CZ (EUCTR) | 31/03/202120210331 | 03/11/202020201103 | Study of efficacy and safety of twice daily oral LNP023 in adult PNH patients with residual anemia despite anti-C5 antibody treatment Study of efficacy and safety of twice daily oral LNP023 in adult PNH patients with residual anemia d ... | 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 A randomized, multicenter, active-comparator controlled, open-label trial to evaluate efficacy and s ... | 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] Paroxysmal Nocturnal Hemoglobinuria (PNH) MedDRA version: 21.1;Level: PT;Classification code 1003404 ... | Product Name: LNP023 Product Code: LNP023 INN or Proposed INN: not yet established Other descriptive name: LNP023 HYDROCHLORIDE SALT Product Name: LNP023 Product Code: LNP023 INN or Proposed INN: not yet established Other descriptive name: LNP023 HYDROCHLORIDE SALT Trade Name: Soliris Product Name: Eculizumab INN or Proposed INN: ECULIZUMAB Trade Name: Ultomiris Product Name: Ravulizumab INN or Proposed INN: RAVULIZUMAB Other descriptive name: ravulizumab Product Name: LNP023 Product Code: LNP023 INN or Proposed INN: not yet established Other descriptive na ... | Novartis Pharma AG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 91 | Phase 3 | United States;Czechia;Taiwan;Spain;United Kingdom;Italy;France;Czech Republic;Hungary;Canada;Brazil;Germany;Netherlands;Japan;Korea, Republic of United States;Czechia;Taiwan;Spain;United Kingdom;Italy;France;Czech Republic;Hungary;Canada;Brazil; ... | ||
| 10 | EUCTR2019-004665-40-DE (EUCTR) | 29/01/202120210129 | 22/09/202020200922 | Study of efficacy and safety of twice daily oral LNP023 in adult PNH patients with residual anemia despite anti-C5 antibody treatment Study of efficacy and safety of twice daily oral LNP023 in adult PNH patients with residual anemia d ... | 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 A randomized, multicenter, active-comparator controlled, open-label trial to evaluate efficacy and s ... | 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] Paroxysmal Nocturnal Hemoglobinuria (PNH) MedDRA version: 21.1;Level: PT;Classification code 1003404 ... | 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 300mg/30ml Product Name: Eculizumab INN or Proposed INN: ECULIZUMAB Trade Name: Ultomiris 300mg/30ml Product Name: Ravulizumab INN or Proposed INN: RAVULIZUMAB Other descriptive name: ravulizumab Product Name: iptacopan Product Code: LNP023 INN or Proposed INN: iptacopan Other descriptive name: LNP ... | Novartis Pharma AG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 91 | Phase 3 | United States;Czechia;Taiwan;Spain;Italy;United Kingdom;France;Czech Republic;Hungary;Canada;Brazil;Germany;Netherlands;Japan;Korea, Republic of United States;Czechia;Taiwan;Spain;Italy;United Kingdom;France;Czech Republic;Hungary;Canada;Brazil; ... |