62. Paroxysmal nocturnal hemoglobinuria Clinical trials / Disease details


Clinical trials : 271 Drugs : 163 - (DrugBank : 49) / Drug target genes : 22 - Drug target pathways : 106

  
12 trials found
No.TrialIDDate_
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Public_titleScientific_titleConditionInterventionPrimary_
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agemin
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PhaseCountries
1EUCTR2017-001418-27-FI
(EUCTR)
01/04/202008/10/2019This trial is designed to determine what effects the investigational medicine, ABP 959, has on the human body, and what effects the body has on theinvestigational medicine after you have been given it, and if this iscomparable to what is seen for the licensed medicine, eculizumab, inpatients with Paroxysmal Nocturnal Hemoglobinuria (PNH).This study will assess if the investigational medicine is safe and effective intreating PNH compared to the licensed medicine.A RANDOMIZED, DOUBLE-BLIND, ACTIVE-CONTROLLED PHASE 3 STUDY EVALUATING THE EFFICACY AND SAFETY OF ABP 959 COMPARED WITH ECULIZUMAB IN ADULT SUBJECTS WITH PAROXYSMAL NOCTURNAL HEMOGLOBINURIA (PNH) - Not applicable Paroxysmal Nocturnal Hemoglobinuria (PNH)
MedDRA version: 21.1;Level: LLT;Classification code 10055629;Term: Paroxysmal nocturnal hemoglobinuria;System Organ Class: 100000004857;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]
Product Name: ABP 959
Product Code: ABP 959
INN or Proposed INN: ECULIZUMAB
Other descriptive name: ABP 959 - biosimilar to eculizumab
Trade Name: Soliris
Product Name: Soliris
INN or Proposed INN: ECULIZUMAB
Trade Name: Soliris
Product Name: Soliris
INN or Proposed INN: ECULIZUMAB
Amgen Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
40Phase 3United States;Portugal;Czechia;Taiwan;Slovenia;Finland;Spain;Ireland;Turkey;United Kingdom;Italy;France;Czech Republic;Brazil;Germany;Netherlands;Norway;Sweden
2EUCTR2017-001418-27-PT
(EUCTR)
04/03/202028/11/2019 This trial is designed to determine what effects the investigational medicine, ABP 959, has on the human body, and what effects the body has on the investigational medicine after you have been given it, and if this is comparable to what is seen for the licensed medicine, eculizumab, in patients with Paroxysmal Nocturnal Hemoglobinuria (PNH). This study will assess if the investigational medicine is safe and effective in treating PNH compared to the licensed medicine.A RANDOMIZED, DOUBLE-BLIND, ACTIVE-CONTROLLED PHASE 3 STUDY EVALUATING THE EFFICACY AND SAFETY OF ABP 959 COMPARED WITH ECULIZUMAB IN ADULT SUBJECTS WITH PAROXYSMAL NOCTURNAL HEMOGLOBINURIA (PNH) - Not applicable Paroxysmal Nocturnal Hemoglobinuria (PNH)
MedDRA version: 21.1;Level: LLT;Classification code 10055629;Term: Paroxysmal nocturnal hemoglobinuria;System Organ Class: 100000004857 ;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]
Product Name: ABP 959
Product Code: ABP 959
INN or Proposed INN: ECULIZUMAB
Other descriptive name: ABP 959 - biosimilar to eculizumab
Trade Name: Soliris
INN or Proposed INN: ECULIZUMAB
Trade Name: Soliris
INN or Proposed INN: ECULIZUMAB
Amgen Inc.NULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
40 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noFrance;United States;Portugal;Czech Republic;Slovenia;Spain;Ireland;Norway;Netherlands;Germany;Italy;United Kingdom
3EUCTR2017-001418-27-SE
(EUCTR)
20/02/202008/11/2019This trial is designed to determine what effects the investigational medicine, ABP 959, has on the human body, and what effects the body has on theinvestigational medicine after you have been given it, and if this iscomparable to what is seen for the licensed medicine, eculizumab, inpatients with Paroxysmal Nocturnal Hemoglobinuria (PNH).This study will assess if the investigational medicine is safe and effective intreating PNH compared to the licensed medicine.A RANDOMIZED, DOUBLE-BLIND, ACTIVE-CONTROLLED PHASE 3 STUDY EVALUATING THE EFFICACY AND SAFETY OF ABP 959 COMPARED WITH ECULIZUMAB IN ADULT SUBJECTS WITH PAROXYSMAL NOCTURNAL HEMOGLOBINURIA (PNH) - Not applicable Paroxysmal Nocturnal Hemoglobinuria (PNH)
MedDRA version: 21.1;Level: LLT;Classification code 10055629;Term: Paroxysmal nocturnal hemoglobinuria;System Organ Class: 100000004857;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]
Product Name: ABP 959
Product Code: ABP 959
INN or Proposed INN: ECULIZUMAB
Other descriptive name: ABP 959 - proposed biosimilar to eculizumab
Trade Name: Soliris
Product Name: Soliris
INN or Proposed INN: ECULIZUMAB
Trade Name: Soliris
Product Name: Soliris
Amgen Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
40Phase 3Sweden;Norway;Netherlands;Germany;Brazil;Czech Republic;France;Italy;United Kingdom;Turkey;Ireland;Spain;Finland;Slovenia;Taiwan;Portugal;United States
4EUCTR2017-001418-27-IE
(EUCTR)
15/01/202002/10/2019This trial is designed to determine what effects the investigational medicine, ABP 959, has on the human body, and what effects the body has on theinvestigational medicine after you have been given it, and if this iscomparable to what is seen for the licensed medicine, eculizumab, inpatients with Paroxysmal Nocturnal Hemoglobinuria (PNH).This study will assess if the investigational medicine is safe and effective intreating PNH compared to the licensed medicine.A RANDOMIZED, DOUBLE-BLIND, ACTIVE-CONTROLLED PHASE 3 STUDY EVALUATING THE EFFICACY AND SAFETY OF ABP 959 COMPARED WITH ECULIZUMAB IN ADULT SUBJECTS WITH PAROXYSMAL NOCTURNAL HEMOGLOBINURIA (PNH) - Not applicable Paroxysmal Nocturnal Hemoglobinuria (PNH)
MedDRA version: 21.1;Level: LLT;Classification code 10055629;Term: Paroxysmal nocturnal hemoglobinuria;System Organ Class: 100000004857;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]
Product Name: ABP 959
Product Code: ABP 959
INN or Proposed INN: ECULIZUMAB
Other descriptive name: ABP 959 - biosimilar to eculizumab
Trade Name: Soliris
Product Name: Soliris
INN or Proposed INN: ECULIZUMAB
Trade Name: Soliris
Product Name: Soliris
INN or Proposed INN: ECULIZUMAB
Amgen Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
40Phase 3United States;Portugal;Czechia;Taiwan;Slovenia;Finland;Spain;Ireland;Turkey;United Kingdom;Italy;France;Czech Republic;Brazil;Germany;Netherlands;Norway;Sweden
5EUCTR2017-001418-27-CZ
(EUCTR)
22/11/201905/08/2019This trial is designed to determine what effects the investigational medicine, ABP 959, has on the human body, and what effects the body has on theinvestigational medicine after you have been given it, and if this iscomparable to what is seen for the licensed medicine, eculizumab, inpatients with Paroxysmal Nocturnal Hemoglobinuria (PNH).This study will assess if the investigational medicine is safe and effective intreating PNH compared to the licensed medicine.A RANDOMIZED, DOUBLE-BLIND, ACTIVE-CONTROLLED PHASE 3 STUDY EVALUATING THE EFFICACY AND SAFETY OF ABP 959 COMPARED WITH ECULIZUMAB IN ADULT SUBJECTS WITH PAROXYSMAL NOCTURNAL HEMOGLOBINURIA (PNH) - Not applicable Paroxysmal Nocturnal Hemoglobinuria (PNH)
MedDRA version: 21.1;Level: LLT;Classification code 10055629;Term: Paroxysmal nocturnal hemoglobinuria;System Organ Class: 100000004857;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]
Product Name: ABP 959
Product Code: ABP 959
INN or Proposed INN: ECULIZUMAB
Other descriptive name: ABP 959 - biosimilar to eculizumab
Trade Name: Soliris
Product Name: Soliris
INN or Proposed INN: ECULIZUMAB
Trade Name: Soliris
Product Name: Soliris
INN or Proposed INN: ECULIZUMAB
Amgen Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
40Phase 3United States;Portugal;Czechia;Taiwan;Slovenia;Finland;Spain;Ireland;Turkey;United Kingdom;Italy;France;Czech Republic;Brazil;Germany;Netherlands;Norway;Sweden
6EUCTR2017-001418-27-SI
(EUCTR)
23/10/201910/09/2019This trial is designed to determine what effects the investigational medicine, ABP 959, has on the human body, and what effects the body has on theinvestigational medicine after you have been given it, and if this iscomparable to what is seen for the licensed medicine, eculizumab, inpatients with Paroxysmal Nocturnal Hemoglobinuria (PNH).This study will assess if the investigational medicine is safe and effective intreating PNH compared to the licensed medicine.A RANDOMIZED, DOUBLE-BLIND, ACTIVE-CONTROLLED PHASE 3 STUDY EVALUATING THE EFFICACY AND SAFETY OF ABP 959 COMPARED WITH ECULIZUMAB IN ADULT SUBJECTS WITH PAROXYSMAL NOCTURNAL HEMOGLOBINURIA (PNH) - Not applicable Paroxysmal Nocturnal Hemoglobinuria (PNH)
MedDRA version: 21.1;Level: LLT;Classification code 10055629;Term: Paroxysmal nocturnal hemoglobinuria;System Organ Class: 100000004857;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]
Product Name: ABP 959
Product Code: ABP 959
INN or Proposed INN: ECULIZUMAB
Other descriptive name: ABP 959 - biosimilar to eculizumab
Trade Name: Soliris
Product Name: Soliris
INN or Proposed INN: ECULIZUMAB
Trade Name: Soliris
Product Name: Soliris
INN or Proposed INN: ECULIZUMAB
Amgen Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
40Phase 3United States;Portugal;Czechia;Taiwan;Slovenia;Finland;Spain;Ireland;Turkey;United Kingdom;Italy;France;Czech Republic;Brazil;Germany;Netherlands;Norway;Sweden
7EUCTR2017-001418-27-NO
(EUCTR)
18/10/201922/08/2019This trial is designed to determine what effects the investigational medicine, ABP 959, has on the human body, and what effects the body has on theinvestigational medicine after you have been given it, and if this iscomparable to what is seen for the licensed medicine, eculizumab, inpatients with Paroxysmal Nocturnal Hemoglobinuria (PNH).This study will assess if the investigational medicine is safe and effective intreating PNH compared to the licensed medicine.A RANDOMIZED, DOUBLE-BLIND, ACTIVE-CONTROLLED PHASE 3 STUDY EVALUATING THE EFFICACY AND SAFETY OF ABP 959 COMPARED WITH ECULIZUMAB IN ADULT SUBJECTS WITH PAROXYSMAL NOCTURNAL HEMOGLOBINURIA (PNH) - Not applicable Paroxysmal Nocturnal Hemoglobinuria (PNH)
MedDRA version: 21.1;Level: LLT;Classification code 10055629;Term: Paroxysmal nocturnal hemoglobinuria;System Organ Class: 100000004857;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]
Product Name: ABP 959
Product Code: ABP 959
INN or Proposed INN: ECULIZUMAB
Other descriptive name: ABP 959 - biosimilar to eculizumab
Trade Name: Soliris
Product Name: Soliris
INN or Proposed INN: ECULIZUMAB
Trade Name: Soliris
Product Name: Soliris
INN or Proposed INN: ECULIZUMAB
Amgen Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
40Phase 3United States;Portugal;Czechia;Taiwan;Slovenia;Finland;Spain;Ireland;Turkey;United Kingdom;Italy;France;Czech Republic;Brazil;Norway;Germany;Netherlands;Sweden
8NCT03818607
(ClinicalTrials.gov)
April 24, 201917/1/2019A Study Evaluating the Efficacy and Safety of ABP 959 Compared With Eculizumab in Adult Participants With PNHA Randomized, Double-Blind, Active-Controlled Phase 3 Study Evaluating the Efficacy and Safety of ABP 959 Compared With Eculizumab in Adult Subjects With Paroxysmal Nocturnal Hemoglobinuria (PNH)Paroxysmal Nocturnal HemoglobinuriaDrug: ABP 959;Drug: EculizumabAmgenNULLActive, not recruiting18 YearsN/AAll42Phase 3United States;Czechia;Finland;France;Ireland;Italy;Netherlands;Norway;Portugal;Slovenia;Spain;Sweden;Turkey;United Kingdom;Germany;Taiwan
9EUCTR2017-001418-27-DE
(EUCTR)
29/01/201927/07/2017 This trial is designed to determine what effects the investigational medicine, ABP 959, has on the human body, and what effects the body has on the investigational medicine after you have been given it, and if this is comparable to what is seen for the licensed medicine, eculizumab, in patients with Paroxysmal Nocturnal Hemoglobinuria (PNH). This study will assess if the investigational medicine is safe and effective in treating PNH compared to the licensed medicine.A RANDOMIZED, DOUBLE-BLIND, ACTIVE-CONTROLLED PHASE 3 STUDY EVALUATING THE EFFICACY AND SAFETY OF ABP 959 COMPARED WITH ECULIZUMAB IN ADULT SUBJECTS WITH PAROXYSMAL NOCTURNAL HEMOGLOBINURIA (PNH) - Not applicable Paroxysmal Nocturnal Hemoglobinuria (PNH)
MedDRA version: 20.1;Level: LLT;Classification code 10055629;Term: Paroxysmal nocturnal hemoglobinuria;System Organ Class: 100000004857 ;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]
Product Name: ABP 959
Product Code: ABP 959
INN or Proposed INN: ECULIZUMAB
Other descriptive name: ABP 959 - biosimilar to eculizumab
Trade Name: Soliris
Product Name: Soliris
INN or Proposed INN: ECULIZUMAB
Amgen Inc.NULLNot Recruiting Female: yes
Male: yes
40 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noFrance;United States;Czech Republic;Slovenia;Spain;Ireland;Norway;Netherlands;Germany;Italy;United Kingdom
10EUCTR2017-001418-27-NL
(EUCTR)
22/01/201902/11/2017 This trial is designed to determine what effects the investigational medicine, ABP 959, has on the human body, and what effects the body has on the investigational medicine after you have been given it, and if this is comparable to what is seen for the licensed medicine, eculizumab, in patients with Paroxysmal Nocturnal Hemoglobinuria (PNH). This study will assess if the investigational medicine is safe and effective in treating PNH compared to the licensed medicine.A RANDOMIZED, DOUBLE-BLIND, ACTIVE-CONTROLLED PHASE 3 STUDY EVALUATING THE EFFICACY AND SAFETY OF ABP 959 COMPARED WITH ECULIZUMAB IN ADULT SUBJECTS WITH PAROXYSMAL NOCTURNAL HEMOGLOBINURIA (PNH) - Not applicable Paroxysmal Nocturnal Hemoglobinuria (PNH)
MedDRA version: 20.0;Level: LLT;Classification code 10055629;Term: Paroxysmal nocturnal hemoglobinuria;System Organ Class: 100000004857 ;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]
Product Name: ABP 959
Product Code: ABP 959
INN or Proposed INN: ECULIZUMAB
Other descriptive name: ABP 959 - biosimilar to eculizumab
Trade Name: Soliris
Product Name: Soliris
INN or Proposed INN: ECULIZUMAB
Amgen Inc.NULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
40 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noSpain;Norway;Germany;Netherlands;Italy;United Kingdom;Korea, Republic of
11EUCTR2017-001418-27-GB
(EUCTR)
14/12/201811/12/2018 This trial is designed to determine what effects the investigational medicine, ABP 959, has on the human body, and what effects the body has on the investigational medicine after you have been given it, and if this is comparable to what is seen for the licensed medicine, eculizumab, in patients with Paroxysmal Nocturnal Hemoglobinuria (PNH). This study will assess if the investigational medicine is safe and effective in treating PNH compared to the licensed medicine.A RANDOMIZED, DOUBLE-BLIND, ACTIVE-CONTROLLED PHASE 3 STUDY EVALUATING THE EFFICACY AND SAFETY OF ABP 959 COMPARED WITH ECULIZUMAB IN ADULT SUBJECTS WITH PAROXYSMAL NOCTURNAL HEMOGLOBINURIA (PNH) - ABP 959 in PNH Paroxysmal Nocturnal Hemoglobinuria (PNH)
MedDRA version: 20.1;Level: LLT;Classification code 10055629;Term: Paroxysmal nocturnal hemoglobinuria;System Organ Class: 100000004857 ;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]
Product Name: ABP 959
Product Code: ABP 959
INN or Proposed INN: ECULIZUMAB
Other descriptive name: ABP 959 - biosimilar to eculizumab
Trade Name: Soliris
Product Name: Soliris
INN or Proposed INN: ECULIZUMAB
Amgen Inc.NULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
40 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noSpain;Norway;Netherlands;Germany;Italy;United Kingdom
12EUCTR2017-001418-27-ES
(EUCTR)
28/08/201731/07/2017This trial is designed to determine what effects the investigational medicine, ABP 959, has on the human body, and what effects the body has on theinvestigational medicine after you have been given it, and if this iscomparable to what is seen for the licensed medicine, eculizumab, inpatients with Paroxysmal Nocturnal Hemoglobinuria (PNH).This study will assess if the investigational medicine is safe and effective intreating PNH compared to the licensed medicine.A RANDOMIZED, DOUBLE-BLIND, ACTIVE-CONTROLLED PHASE 3 STUDY EVALUATING THE EFFICACY AND SAFETY OF ABP 959 COMPARED WITH ECULIZUMAB IN ADULT SUBJECTS WITH PAROXYSMAL NOCTURNAL HEMOGLOBINURIA (PNH) - Not applicable Paroxysmal Nocturnal Hemoglobinuria (PNH);Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]Product Name: ABP 959
Product Code: ABP 959
INN or Proposed INN: ECULIZUMAB
Other descriptive name: ABP 959 - biosimilar to eculizumab
Trade Name: Soliris
Product Name: Soliris
INN or Proposed INN: ECULIZUMAB
Amgen Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
40Phase 3France;Spain;Russian Federation;Netherlands;Germany;Japan;Italy;United Kingdom;Korea, Republic of