62. 発作性夜間ヘモグロビン尿症 Paroxysmal nocturnal hemoglobinuria Clinical trials / Disease details

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

14 trials found

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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-jRCT2031220046	28/04/2022	28/04/2022	Pegcetacoplan Long-term Safety and Efficacy Extension Study	AN OPEN-LABEL, NONRANDOMIZED, MULTICENTER EXTENSION STUDY TO EVALUATE THE LONG-TERM SAFETY AND EFFIC ...	Paroxysmal Nocturnal Hemoglobinuria (PNH)	A subcutaneous dose of pegcetacoplan (APL-2) 1080 mg twice a week, 3 times a week or every 3 days	Machaidze Zurab	NULL	Not Recruiting	>= 18age old	Not applicable	Both	10	Phase 3	the United States;South Korea;Australia;Malaysia;Hong Kong;Philippines;Singapore;Thailand;Peru;Colom ...
2	JPRN-jRCT2031210645	04/03/2022	04/03/2022	A Phase 3, Randomized, Multicenter, Open-label, Active-comparator Controlled Study to Evaluate the E ...	A Phase 3, Randomized, Multicenter, Open-label, Active-comparator Controlled Study to Evaluate the E ...	Paroxysmal Nocturnal Hemoglobinuria (PNH)	A subcutaneous dose of pegcetacoplan(APL-2) 1080 mg twice weekly (or change to a dose of 1080 mg eve ...	Machaidze Zurab	NULL	Complete	>= 18age old	Not applicable	Both	8	Phase 3	the U.S.;Korea;Australia;Canada;Belgium;France;Germany;Russia;Spain;the United Kingdom;Japan
3	NCT04729062 (ClinicalTrials.gov)	April 5, 2021	25/1/2021	Pegcetacoplan Early Access Program for PNH	Early Access Program (EAP) For The Treatment of Paroxysmal Nocturnal Hemoglobinuria (PNH) With Pegce ...	Paroxysmal Nocturnal Hemoglobinuria (PNH)	Drug: Pegcetacoplan	Apellis Pharmaceuticals, Inc.	NULL	No longer available	18 Years	N/A	All			United States
4	EUCTR2019-001106-23-FR (EUCTR)	04/02/2020	15/10/2019	An Open Label, Non-Randomized, Multi-Center Extension Study to Evaluate the Long Term Safety and Eff ...	An Open Label, Non-Randomized, Multi-Center Extension Study to Evaluate the Long Term Safety and Eff ...	Paroxysmal Nocturnal Hemoglobinuria MedDRA version: 21.1;Level: LLT;Classification code 10055629;Ter ...	Product Name: APL-2 Product Code: APL-2 INN or Proposed INN: pegcetacoplan Other descriptive name: APL- ...	Apellis Pharmaceuticals, Inc.	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	119	Phase 3	United States;Serbia;Hong Kong;Thailand;Spain;Russian Federation;United Kingdom;France;Canada;Belgiu ...
5	EUCTR2019-001106-23-ES (EUCTR)	22/01/2020	14/01/2020	An Open Label, Non-Randomized, Multi-Center Extension Study to Evaluate the Long Term Safety and Eff ...	An Open Label, Non-Randomized, Multi-Center Extension Study to Evaluate the Long Term Safety and Eff ...	Paroxysmal Nocturnal Hemoglobinuria MedDRA version: 21.1;Level: LLT;Classification code 10055629;Ter ...	Product Name: APL-2 Product Code: APL-2 INN or Proposed INN: pegcetacoplan Other descriptive name: APL- ...	Apellis Pharmaceuticals, Inc.	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	119	Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (P ...	Serbia;United States;Hong Kong;Spain;Thailand;Russian Federation;United Kingdom;France;Canada;Poland ...
6	EUCTR2019-001106-23-GB (EUCTR)	19/12/2019	30/09/2019	An Open Label, Nonrandomized, Multicenter Extension Study to Evaluate the Long Term Safety and Effic ...	An Open Label, Nonrandomized, Multicenter Extension Study to Evaluate the Long Term Safety and Effic ...	Paroxysmal Nocturnal Hemoglobinuria MedDRA version: 21.1;Level: LLT;Classification code 10055629;Ter ...	Product Name: Pegcetacoplan (APL-2) Product Code: Pegcetacoplan (APL-2) INN or Proposed INN: pegcetacopl ...	Apellis Pharmaceuticals, Inc.	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	160	Phase 3	Serbia;United States;Hong Kong;Spain;Thailand;Russian Federation;United Kingdom;France;Canada;Malays ...
7	NCT04085601 (ClinicalTrials.gov)	August 27, 2019	9/9/2019	A Study to Evaluate the Efficacy and Safety of Pegcetacoplan in Patients With PNH	A Phase 3, Randomized, Multicenter, Open-Label, Controlled Study to Evaluate the Efficacy and Safety ...	Paroxysmal Nocturnal Hemoglobinuria	Drug: APL-2	Apellis Pharmaceuticals, Inc.	NULL	Completed	18 Years	N/A	All	53	Phase 3	Colombia;Hong Kong;Malaysia;Mexico;Peru;Philippines;Poland;Serbia;Singapore;Thailand
8	EUCTR2019-001106-23-BG (EUCTR)	09/08/2019	09/05/2019	An Open-label, Nonrandomized, Multicenter Extension Study to Evaluate the Long-term Safety and Effic ...	An Open-label, Nonrandomized, Multicenter Extension Study to Evaluate the Long-term Safety and Effic ...	Paroxysmal Nocturnal Hemoglobinuria MedDRA version: 21.1;Level: LLT;Classification code 10055629;Ter ...	Product Name: pegcetacoplan Product Code: pegcetacoplan INN or Proposed INN: pegcetacoplan Other descri ...	Apellis Pharmaceuticals, Inc.	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	160	Phase 3	Serbia;United States;Hong Kong;Spain;Thailand;Ireland;Russian Federation;United Kingdom;Italy;France ...
9	EUCTR2018-004220-11-PL (EUCTR)	23/07/2019	13/05/2019	A Research Study to Gather Scientific Information About the Efficacy and Safety of the Investigation ...	A Phase 3, Randomized, Multicenter, Open-Label, Controlled Study to Evaluate the Efficacy and Safety ...	Paroxysmal Nocturnal Hemoglobinuria (PNH) MedDRA version: 20.1;Level: LLT;Classification code 100556 ...	Product Name: APL-2 Product Code: APL-2 INN or Proposed INN: pegcetacoplan Other descriptive name: APL- ...	Apellis Pharmaceuticals, Inc.	NULL	Not Recruiting			Female: yes Male: yes	54	Phase 3	Serbia;Philippines;Hungary;Hong Kong;Mexico;Argentina;Thailand;Malaysia;Brazil;Poland;Peru;Colombia
10	EUCTR2017-004268-36-GB (EUCTR)	08/01/2019	21/08/2018	A Research Study to Gather Scientific Information About the Efficacy, Safety, and Tolerability of th ...	A Phase III, Randomized, Multi-Center, Open-Label, Active-Comparator Controlled Study to Evaluate th ...	PNH is an acquired, rare, clonal, non-malignant hematologic disease characterized by complement-medi ...	Product Name: Pegcetacoplan (APL-2) Product Code: Pegcetacoplan (APL-2) INN or Proposed INN: n/a Other de ...	Apellis Pharmaceuticals, Inc.	NULL	Not Recruiting			Female: yes Male: yes	70	Phase 3	United States;Spain;Russian Federation;United Kingdom;Italy;France;Canada;Belgium;Australia;Germany; ...

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