ACH-0145228 ( DrugBank: - )


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4

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_
enrollment
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Public_titleScientific_titleConditionInterventionPrimary_
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agemin
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agemax
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PhaseCountries
1EUCTR2019-003830-17-ES
(EUCTR)
02/11/202114/07/2021Study of the Oral Factor D (FD) Inhibitor ALXN2050 (ACH-0145228) in Paroxysmal Nocturnal Hemoglobinuria (PNH) Patients as MonotherapyA Phase 2 Open-Label Proof of Concept Study to Assess the Efficacy, Safety, and Pharmacokinetics of the Oral Factor D (FD) Inhibitor ALXN2050 (ACH-0145228) in Paroxysmal Nocturnal Hemoglobinuria (PNH) Patients as Monotherapy - Study of the Oral Factor D (FD) Inhibitor ALXN2050 in PNH Patients as Monotherapy 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: ALXN2050
Product Code: ALXN2050
INN or Proposed INN: N/A
Other descriptive name: ACH-0145228
Alexion Pharmaceuticals Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
26Phase 2France;Canada;Spain;Turkey;Germany;United Kingdom;Italy;New Zealand;Korea, Republic of
2EUCTR2019-003830-17-IT
(EUCTR)
13/10/202123/06/2020Study of the Oral Factor D (fD) Inhibitor ACH-0145228 in Paroxysmal Nocturnal Hemoglobinuria (PNH) Patients as Monotherapy and with background use of an Approved C5 InhibitorA Phase 2 Open-Label Proof of Concept Study to Assess the Efficacy, Safety, and Pharmacokinetics of the Oral Factor D (FD) Inhibitor ACH-0145228 in Paroxysmal Nocturnal Hemoglobinuria (PNH) Patients as Monotherapy and with an Approved C5 Inhibitor as Background 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] - Immune System Diseases [C20]
Product Name: ALXN2050
Product Code: ACH-0145228
INN or Proposed INN: N/A
Other descriptive name: ACH-0145228
Product Name: ALXN2050
Product Code: ACH-0145228
INN or Proposed INN: N/A
Other descriptive name: ACH-0145228
Achillion Pharmaceuticals, Inc., a wholly owned subsidiary of Alexion Pharmaceuticals Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
26Phase 2United States;Spain;United Kingdom;New Zealand;Italy;Korea, Republic of
3EUCTR2019-003830-17-GB
(EUCTR)
16/09/202016/06/2020Study of the Oral Factor D (fD) Inhibitor ACH-0145228 in Paroxysmal Nocturnal Hemoglobinuria (PNH) Patients as Monotherapy and with background use of an Approved C5 InhibitorA Phase 2 Open-Label Proof of Concept Study to Assess the Efficacy, Safety, and Pharmacokinetics of the Oral Factor D (FD) Inhibitor ACH-0145228 in Paroxysmal Nocturnal Hemoglobinuria (PNH) Patients as Monotherapy and with an Approved C5 Inhibitor as Background 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] - Immune System Diseases [C20]
Product Name: ALXN2050
Product Code: ACH-0145228
INN or Proposed INN: N/A
Other descriptive name: ACH-0145228
Product Name: ALXN2050
Product Code: ACH-0145228
INN or Proposed INN: N/A
Other descriptive name: ACH-0145228
Achillion Pharmaceuticals, Inc., a wholly owned subsidiary of Alexion Pharmaceuticals Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
26Phase 2United States;New Zealand;Italy;United Kingdom;Korea, Republic of
4NCT04170023
(ClinicalTrials.gov)
December 16, 20196/11/2019Study of the Oral Factor D (FD) Inhibitor ALXN2050 in PNH Patients as MonotherapyA Phase 2 Open-Label Proof of Concept Study to Assess the Efficacy, Safety, and Pharmacokinetics of the Oral Factor D (FD) Inhibitor ALXN2050 (ACH-0145228) in Paroxysmal Nocturnal Hemoglobinuria (PNH) Patients as MonotherapyParoxysmal Nocturnal Hemoglobinuria (PNH)Drug: ALXN2050Alexion PharmaceuticalsNULLActive, not recruiting18 YearsN/AAll26Phase 2Canada;Italy;Korea, Republic of;New Zealand;Spain;Turkey;United Kingdom;Germany;United States