Iptacopan (LNP023) ( DrugBank: Iptacopan )


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9

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.TrialIDDate_
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Public_titleScientific_titleConditionInterventionPrimary_
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agemin
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PhaseCountries
1EUCTR2020-004385-19-NL
(EUCTR)
11/01/202217/11/2021Long-term safety and tolerability of iptacopan in patients with Paroxysmal Nocturnal HemoglobinuriaAn 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. 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
Novartis Pharma AGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
165Phase 3United States;Taiwan;Spain;Lithuania;Italy;France;Brazil;Malaysia;Singapore;Netherlands;China;Japan;Korea, Republic of
2EUCTR2020-004385-19-CZ
(EUCTR)
16/12/202127/07/2021Long-term safety and tolerability of iptacopan in patients with Paroxysmal Nocturnal HemoglobinuriaAn 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. 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
Novartis Pharma AGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
165Phase 3United States;Taiwan;Spain;Lithuania;Italy;France;Czech Republic;Brazil;Malaysia;Singapore;Netherlands;China;Japan;Korea, Republic of
3JPRN-jRCT2021210059
09/12/202117/12/2021Long-term Safety and Tolerability of Iptacopan in Patients With Paroxysmal Nocturnal HemoglobinuriaAn 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. Paroxysmal Nocturnal HemoglobinuriaTaken orally b.i.d. Dosage supplied: 200 mg Dosage form: hard gelatin capsule Route of administration: oralSuzuki KazuyukiNULLRecruiting>= 18age oldNot applicableBoth19Phase 3Italy;Republic of Korea;Taiwan;Japan
4EUCTR2020-004385-19-FR
(EUCTR)
31/08/202115/07/2021Long-term safety and tolerability of iptacopan in patients with Paroxysmal Nocturnal HemoglobinuriaAn 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. 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
Novartis Pharma AGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
165Phase 3United States;France;Taiwan;Spain;Malaysia;Brazil;Singapore;Lithuania;Italy;Japan;China;Korea, Republic of
5EUCTR2020-004385-19-ES
(EUCTR)
30/07/202123/06/2021Long-term safety and tolerability of iptacopan in patients with Paroxysmal Nocturnal HemoglobinuriaAn 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. 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
Novartis Farmacéutica, S.A.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
165Phase 3United States;Taiwan;Malaysia;Brazil;Spain;Singapore;Japan;China;Korea, Republic of
6NCT04747613
(ClinicalTrials.gov)
July 27, 20215/2/2021Long-term Safety and Tolerability of Iptacopan in Patients With Paroxysmal Nocturnal HemoglobinuriaAn 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 Phase3 Studies With IptacopanParoxysmal Nocturnal HemoglobinuriaDrug: IptacopanNovartis PharmaceuticalsNULLRecruiting18 YearsN/AAll167Phase 3United States;Brazil;China;Czechia;France;Germany;Italy;Japan;Korea, Republic of;Lithuania;Malaysia;Netherlands;Singapore;Spain;Taiwan;United Kingdom
7NCT04820530
(ClinicalTrials.gov)
July 19, 202125/3/2021Study of Efficacy and Safety of Twice Daily Oral Iptacopan (LNP023) in Adult PNH Patients Who Are Naive to Complement Inhibitor TherapyA 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 TherapyParoxysmal Nocturnal Hemoglobinuria (PNH)Drug: Iptacopan (LNP023)Novartis PharmaceuticalsNULLActive, not recruiting18 YearsN/AAll40Phase 3China;France;Germany;Italy;Korea, Republic of;Malaysia;Singapore;United Kingdom;Czechia;Japan
8EUCTR2020-004385-19-LT
(EUCTR)
15/07/202120/04/2021Long-term safety and tolerability of iptacopan in patients with Paroxysmal Nocturnal HemoglobinuriaAn 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. 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
Novartis Pharma AGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
165Phase 3United States;Taiwan;Spain;Lithuania;Italy;France;Brazil;Malaysia;Singapore;Netherlands;China;Japan;Korea, Republic of
9EUCTR2020-004385-19-IT
(EUCTR)
15/06/202108/06/2021Long-term safety and tolerability of iptacopan in patients with Paroxysmal Nocturnal HemoglobinuriaAn 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. - - 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]
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
NOVARTIS PHARMA AGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
165Phase 3United States;Taiwan;Spain;Malaysia;Brazil;Singapore;Korea, Democratic People's Republic of;Lithuania;Japan;China;Italy