H5G1.1-mAb ( DrugBank: - )


3 diseases
IDDisease name (Link within this page)Number of trials
13Multiple sclerosis/Neuromyelitis optica2
50Dermatomyositis1
62Paroxysmal nocturnal hemoglobinuria3

13. Multiple sclerosis/Neuromyelitis optica


Clinical trials : 3,340 Drugs : 2,163 - (DrugBank : 383) / Drug target genes : 241 - Drug target pathways : 238
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1EUCTR2019-001829-26-DE
(EUCTR)
19/10/202008/01/2020A Trial to Evaluate the Safety and Activity of Eculizumab in PediatricPatients with Relapsing Neuromyelitis Optica Spectrum Disorder (NMOSD)A Phase 2/3 Open-Label, Single-Arm Trial to Evaluate the Safety and Activity of Eculizumab in Pediatric Patients with Relapsing Neuromyelitis Optica Spectrum Disorder Neuromyelitis Optica Spectrum Disorder (NMOSD)
MedDRA version: 21.1;Level: LLT;Classification code 10077879;Term: Neuromyelitis optica spectrum disorder relapse;System Organ Class: 100000004852;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: Soliris
Product Name: Soliris
Product Code: Soliris
INN or Proposed INN: ECULIZUMAB
Other descriptive name: h5G1.1-mAb
Alexion Pharmaceuticals Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
12Phase 2;Phase 3United States;Canada;Spain;Germany;Italy;Japan;Korea, Republic of
2EUCTR2019-001829-26-ES
(EUCTR)
18/12/201906/11/2019 A Trial to Evaluate the Safety and Activity of Eculizumab in Pediatric Patients with Relapsing Neuromyelitis Optica Spectrum Disorder (NMOSD)A Phase 2/3 Open-Label, Single-Arm Trial to Evaluate the Safety and Activity of Eculizumab in Pediatric Patients with Relapsing Neuromyelitis Optica Spectrum Disorder Neuromyelitis Optica Spectrum Disorder (NMOSD)
MedDRA version: 21.1;Level: LLT;Classification code 10077879;Term: Neuromyelitis optica spectrum disorder relapse;System Organ Class: 100000004852 ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: Soliris
INN or Proposed INN: ECULIZUMAB
Other descriptive name: h5G1.1-mAb
Alexion Pharmaceuticals Inc.NULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
15 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noUnited States;Canada;Spain;Germany;Japan;Italy;Korea, Republic of

50. Dermatomyositis


Clinical trials : 194 Drugs : 244 - (DrugBank : 89) / Drug target genes : 50 - Drug target pathways : 151
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1NCT00005571
(ClinicalTrials.gov)
April 200025/4/2000Safety and Effectiveness of h5G1.1-mAb for DermatomyositisA Randomized, Third-Party-Blind, Placebo-Controlled Pilot Study of the Effect of h5G1.1-mAb on Dermatomyositis PatientsDermatomyositisDrug: h5G1.1-mAbNational Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)NULLCompletedN/AN/ABoth17Phase 2United States

62. Paroxysmal nocturnal hemoglobinuria


Clinical trials : 292 Drugs : 151 - (DrugBank : 49) / Drug target genes : 22 - Drug target pathways : 108
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1NCT01194804
(ClinicalTrials.gov)
April 200830/8/2010E07-001: Safety and Efficacy Extension Study of Eculizumab in Paroxysmal Nocturnal Hemoglobinuria PatientsPhase II Clinical Study of Eculizumab (h5G1.1-mAb) in Hemolytic Paroxysmal Nocturnal Hemoglobinuria (PNH) Patients: Extension Study to C07-001 ProtocolParoxysmal Nocturnal HemoglobinuriaDrug: EculizumabAlexion PharmaceuticalsCMIC Co, Ltd. JapanCompleted12 YearsN/AAll27Phase 2NULL
2NCT01192399
(ClinicalTrials.gov)
November 200730/8/2010Safety and Efficacy Study of Eculizumab in Paroxysmal Nocturnal Hemoglobinuria PatientsPhase II Clinical Study of Eculizumab (h5G1.1-mAb) in Hemolytic Paroxysmal Nocturnal Hemoglobinuria (PNH) PatientsParoxysmal Nocturnal HemoglobinuriaBiological: EculizumabAlexion PharmaceuticalsNULLCompleted12 YearsN/AAll29Phase 2NULL
3EUCTR2005-000043-28-IT
(EUCTR)
01/09/200506/02/2007A Phase III Open label extension study of Eculizumab in patients with transfusion dependent hemolytic paroxysmal nocturnal hemoglobinuria PNH who have participated in Triumph C04-001 , Shepherd C04-002 or X03-001 studiesA Phase III Open label extension study of Eculizumab in patients with transfusion dependent hemolytic paroxysmal nocturnal hemoglobinuria PNH who have participated in Triumph C04-001 , Shepherd C04-002 or X03-001 studies paroxymal nocturnal hemoglobinuria
MedDRA version: 6.1;Level: PT;Classification code 10034042
Product Name: Eculizumab
Product Code: h5G1.1-mAb
Product Name: Eculizumab
Product Code: h5G1.1-mAb
ALEXION PHARMACEUTICALS INCNULLNot RecruitingFemale: yes
Male: yes
170Phase 3Germany;United Kingdom;Spain;Ireland;Italy;Sweden