ABP 959 - biosimilar to eculizumab ( DrugBank: Eculizumab )

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	10

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

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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	EUCTR2017-001418-27-FI (EUCTR)	01/04/2020	08/10/2019	This trial is designed to determine what effects the investigational medicine, ABP 959, has on the h ...	A RANDOMIZED, DOUBLE-BLIND, ACTIVE-CONTROLLED PHASE 3 STUDY EVALUATING THE EFFICACY AND SAFETY OF AB ...	Paroxysmal Nocturnal Hemoglobinuria (PNH) MedDRA version: 21.1;Level: LLT;Classification code 100556 ...	Product Name: ABP 959 Product Code: ABP 959 INN or Proposed INN: ECULIZUMAB Other descriptive name: ABP ...	Amgen Inc.	NULL	Not Recruiting			Female: yes Male: yes	40	Phase 3	United States;Portugal;Czechia;Taiwan;Slovenia;Finland;Spain;Ireland;Turkey;United Kingdom;Italy;Fra ...
2	EUCTR2017-001418-27-PT (EUCTR)	04/03/2020	28/11/2019	This trial is designed to determine what effects the investigational medicine, ABP 959, has on the h ...	A RANDOMIZED, DOUBLE-BLIND, ACTIVE-CONTROLLED PHASE 3 STUDY EVALUATING THE EFFICACY AND SAFETY OF AB ...	Paroxysmal Nocturnal Hemoglobinuria (PNH) MedDRA version: 21.1;Level: LLT;Classification code 100556 ...	Product Name: ABP 959 Product Code: ABP 959 INN or Proposed INN: ECULIZUMAB Other descriptive name: ABP ...	Amgen Inc.	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	40	Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (P ...	France;United States;Portugal;Czech Republic;Slovenia;Spain;Ireland;Norway;Netherlands;Germany;Italy ...
3	EUCTR2017-001418-27-IE (EUCTR)	15/01/2020	02/10/2019	This trial is designed to determine what effects the investigational medicine, ABP 959, has on the h ...	A RANDOMIZED, DOUBLE-BLIND, ACTIVE-CONTROLLED PHASE 3 STUDY EVALUATING THE EFFICACY AND SAFETY OF AB ...	Paroxysmal Nocturnal Hemoglobinuria (PNH) MedDRA version: 21.1;Level: LLT;Classification code 100556 ...	Product Name: ABP 959 Product Code: ABP 959 INN or Proposed INN: ECULIZUMAB Other descriptive name: ABP ...	Amgen Inc.	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	40	Phase 3	United States;Portugal;Czechia;Taiwan;Slovenia;Finland;Spain;Ireland;Turkey;United Kingdom;Italy;Fra ...
4	EUCTR2017-001418-27-CZ (EUCTR)	22/11/2019	05/08/2019	This trial is designed to determine what effects the investigational medicine, ABP 959, has on the h ...	A RANDOMIZED, DOUBLE-BLIND, ACTIVE-CONTROLLED PHASE 3 STUDY EVALUATING THE EFFICACY AND SAFETY OF AB ...	Paroxysmal Nocturnal Hemoglobinuria (PNH) MedDRA version: 21.1;Level: LLT;Classification code 100556 ...	Product Name: ABP 959 Product Code: ABP 959 INN or Proposed INN: ECULIZUMAB Other descriptive name: ABP ...	Amgen Inc.	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	40	Phase 3	United States;Portugal;Czechia;Taiwan;Slovenia;Finland;Spain;Ireland;Turkey;United Kingdom;Italy;Fra ...
5	EUCTR2017-001418-27-SI (EUCTR)	23/10/2019	10/09/2019	This trial is designed to determine what effects the investigational medicine, ABP 959, has on the h ...	A RANDOMIZED, DOUBLE-BLIND, ACTIVE-CONTROLLED PHASE 3 STUDY EVALUATING THE EFFICACY AND SAFETY OF AB ...	Paroxysmal Nocturnal Hemoglobinuria (PNH) MedDRA version: 21.1;Level: LLT;Classification code 100556 ...	Product Name: ABP 959 Product Code: ABP 959 INN or Proposed INN: ECULIZUMAB Other descriptive name: ABP ...	Amgen Inc.	NULL	Not Recruiting			Female: yes Male: yes	40	Phase 3	United States;Portugal;Czechia;Taiwan;Slovenia;Finland;Spain;Ireland;Turkey;United Kingdom;Italy;Fra ...
6	EUCTR2017-001418-27-NO (EUCTR)	18/10/2019	22/08/2019	This trial is designed to determine what effects the investigational medicine, ABP 959, has on the h ...	A RANDOMIZED, DOUBLE-BLIND, ACTIVE-CONTROLLED PHASE 3 STUDY EVALUATING THE EFFICACY AND SAFETY OF AB ...	Paroxysmal Nocturnal Hemoglobinuria (PNH) MedDRA version: 21.1;Level: LLT;Classification code 100556 ...	Product Name: ABP 959 Product Code: ABP 959 INN or Proposed INN: ECULIZUMAB Other descriptive name: ABP ...	Amgen Inc.	NULL	Not Recruiting			Female: yes Male: yes	40	Phase 3	United States;Portugal;Czechia;Taiwan;Slovenia;Finland;Spain;Ireland;Turkey;United Kingdom;Italy;Fra ...
7	EUCTR2017-001418-27-DE (EUCTR)	29/01/2019	27/07/2017	This trial is designed to determine what effects the investigational medicine, ABP 959, has on the h ...	A RANDOMIZED, DOUBLE-BLIND, ACTIVE-CONTROLLED PHASE 3 STUDY EVALUATING THE EFFICACY AND SAFETY OF AB ...	Paroxysmal Nocturnal Hemoglobinuria (PNH) MedDRA version: 20.1;Level: LLT;Classification code 100556 ...	Product Name: ABP 959 Product Code: ABP 959 INN or Proposed INN: ECULIZUMAB Other descriptive name: ABP ...	Amgen Inc.	NULL	Not Recruiting			Female: yes Male: yes	40	Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (P ...	France;United States;Czech Republic;Slovenia;Spain;Ireland;Norway;Netherlands;Germany;Italy;United K ...
8	EUCTR2017-001418-27-NL (EUCTR)	22/01/2019	02/11/2017	This trial is designed to determine what effects the investigational medicine, ABP 959, has on the h ...	A RANDOMIZED, DOUBLE-BLIND, ACTIVE-CONTROLLED PHASE 3 STUDY EVALUATING THE EFFICACY AND SAFETY OF AB ...	Paroxysmal Nocturnal Hemoglobinuria (PNH) MedDRA version: 20.0;Level: LLT;Classification code 100556 ...	Product Name: ABP 959 Product Code: ABP 959 INN or Proposed INN: ECULIZUMAB Other descriptive name: ABP ...	Amgen Inc.	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	40	Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (P ...	Spain;Norway;Germany;Netherlands;Italy;United Kingdom;Korea, Republic of
9	EUCTR2017-001418-27-GB (EUCTR)	14/12/2018	11/12/2018	This trial is designed to determine what effects the investigational medicine, ABP 959, has on the h ...	A RANDOMIZED, DOUBLE-BLIND, ACTIVE-CONTROLLED PHASE 3 STUDY EVALUATING THE EFFICACY AND SAFETY OF AB ...	Paroxysmal Nocturnal Hemoglobinuria (PNH) MedDRA version: 20.1;Level: LLT;Classification code 100556 ...	Product Name: ABP 959 Product Code: ABP 959 INN or Proposed INN: ECULIZUMAB Other descriptive name: ABP ...	Amgen Inc.	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	40	Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (P ...	Spain;Norway;Netherlands;Germany;Italy;United Kingdom
10	EUCTR2017-001418-27-ES (EUCTR)	28/08/2017	31/07/2017	This trial is designed to determine what effects the investigational medicine, ABP 959, has on the h ...	A RANDOMIZED, DOUBLE-BLIND, ACTIVE-CONTROLLED PHASE 3 STUDY EVALUATING THE EFFICACY AND SAFETY OF AB ...	Paroxysmal Nocturnal Hemoglobinuria (PNH);Therapeutic area: Diseases [C] - Blood and lymphatic disea ...	Product Name: ABP 959 Product Code: ABP 959 INN or Proposed INN: ECULIZUMAB Other descriptive name: ABP ...	Amgen Inc.	NULL	Not Recruiting			Female: yes Male: yes	40	Phase 3	Portugal;Slovenia;Finland;Spain;Ireland;Russian Federation;Italy;United Kingdom;France;Czech Republi ...

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