Lenograstim ( DrugBank: Lenograstim )


7 diseases
告示番号疾患名(ページ内リンク)臨床試験数
2筋萎縮性側索硬化症1
13多発性硬化症/視神経脊髄炎1
16クロウ・深瀬症候群1
18脊髄小脳変性症(多系統萎縮症を除く。)1
19ライソゾーム病1
57特発性拡張型心筋症1
65原発性免疫不全症候群2

2. 筋萎縮性側索硬化症


臨床試験数 : 624 薬物数 : 623 - (DrugBank : 160) / 標的遺伝子数 : 172 - 標的パスウェイ数 : 225
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1EUCTR2005-003248-75-IT
(EUCTR)
31/08/200502/09/2005PILOT STUDY ON SAFETY AND TOLERABILITY OF REPEATED MOBILIZATION PROCEDURES OF OSTEO-MEDULLARY DERIVED CELLS IN PATIENTS WITH AMYOTROPHIC LATERAL SCLEROSISPILOT STUDY ON SAFETY AND TOLERABILITY OF REPEATED MOBILIZATION PROCEDURES OF OSTEO-MEDULLARY DERIVED CELLS IN PATIENTS WITH AMYOTROPHIC LATERAL SCLEROSIS SLOWING OF ALS PROGRESSION
MedDRA version: 6.1;Level: PT;Classification code 10002026
Trade Name: MYELOSTIM 34*1FL 263MCG+1SIR
INN or Proposed INN: Lenograstim
AZIENDA SANITARIA OSPEDALIERA S. GIOVANNI BATTISTA DI TORINONULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
Italy

13. 多発性硬化症/視神経脊髄炎


臨床試験数 : 3,342 薬物数 : 2,380 - (DrugBank : 407) / 標的遺伝子数 : 266 - 標的パスウェイ数 : 240
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1EUCTR2019-001549-42-GB
(EUCTR)
27/03/202003/02/2020Stem cell transplantation versus disease modifying therapy (alemtuzumab or ocrelizumab) for patients with highly active relapsing remitting MSA multicentre, randomised controlled trial to evaluate the efficacy of autologous haematopoietic stem cell transplantation versus alemtuzumab or ocrelizumab in relapsing remitting multiple sclerosis. - StarMS Highly active relapsing remitting multiple sclerosis
MedDRA version: 20.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Cyclophosphamide
INN or Proposed INN: Cyclophosphamide monohydrate
INN or Proposed INN: Cyclophosphamide monohydrate
Product Name: Filgrastim
INN or Proposed INN: Filgrastim
Trade Name: Thymoglobuline
Product Name: Thymoglobuline
INN or Proposed INN: Rabbit anti-human thymocyte immunoglobulin
INN or Proposed INN: Rabbit anti-human thymocyte immunoglobulin
INN or Proposed INN: Rabbit anti-human thymocyte immunoglobulin
Trade Name: Alemtuzumab
Product Name: Alemtuzumab
INN or Proposed INN: Alemtuzumab
Product Name: Lenograstim
INN or Proposed INN: Lenograstim
Trade Name: Ocrelizumab
Product Name: Ocrelizumab
Sheffield Teaching HospitalsNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
198Phase 3United Kingdom

16. クロウ・深瀬症候群


臨床試験数 : 13 薬物数 : 18 - (DrugBank : 8) / 標的遺伝子数 : 5 - 標的パスウェイ数 : 81
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1JPRN-jRCTs031180421
15/08/201625/03/2019LDCY-POEMS studyPhase II study of efficiency of peripheral blood stem cell harvest using low-dose cyclophosphamide plus G-CSF for POEMS syndrome POEMS syndrome
POEMS syndrome
Treatment by cyclophosphamide, mesna, graniserton, and lenograstim. Autologous peripheral blood stem cell harvest (auto-PBSCH)Sakaida EmikoNULLRecruiting>= 20age old<= 70age oldBoth14Phase 2Japan

18. 脊髄小脳変性症(多系統萎縮症を除く。)


臨床試験数 : 71 薬物数 : 101 - (DrugBank : 30) / 標的遺伝子数 : 45 - 標的パスウェイ数 : 65
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1EUCTR2017-003084-34-GB
(EUCTR)
22/01/201828/11/2017Testing granulocyte-colony stimulating factor (GCSF) in patients with Friedreich AtaxiaThe pharmacological effects of granulocyte-colony stimulating factor (GCSF) on frataxin expression in patients with Friedreich Ataxia - GCSF for Friedreich Ataxia Friedreich Ataxia
MedDRA version: 20.0;Level: LLT;Classification code 10003592;Term: Ataxia cerebellar;System Organ Class: 100000004852
MedDRA version: 20.0;Level: PT;Classification code 10017374;Term: Friedreich's ataxia;System Organ Class: 10010331 - Congenital, familial and genetic disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: Granocyte
Product Name: Granocyte
INN or Proposed INN: rHuG-CSF
Other descriptive name: Lenograstim
University of BristolNULLNot Recruiting Female:
Male:
7 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): noUnited Kingdom

19. ライソゾーム病


臨床試験数 : 854 薬物数 : 727 - (DrugBank : 105) / 標的遺伝子数 : 69 - 標的パスウェイ数 : 190
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1EUCTR2017-002430-23-IT
(EUCTR)
14/03/201809/03/2020Gene therapy study with autologous hemapoietic stem cells for patients affected by MPSIHA phase I/II study evaluating safety and efficacy of autologous hematopoietic stem and progenitor cells genetically modified with IDUA lentiviral vector encoding for the human a-L-iduronidase gene for the treatment of patients affected by Mucopolysaccharidosis Type I, Hurler variant - TigetT10_MPS1H Mucopolysaccharidosis type I Hurler
MedDRA version: 20.1;Level: PT;Classification code 10056886;Term: Mucopolysaccharidosis I;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Body processes [G] - Genetic Phenomena [G05]
Other descriptive name: Cellule CD34+ autologhe trasdotte con IDUA LV codificante per il cDNA dell'alfa-L-iduronidasi
Trade Name: BUSILVEX - 6 MG/ML - CONCENTRATO PER SOLUZIONE PER INFUSIONE - USO ENDOVENOSO - FLACONCINO - 10 ML 8 FLACONCINI
INN or Proposed INN: BUSULFANO
Other descriptive name: BUSULFANO
Trade Name: FLUDARABINA ACCORD - 25 MG/ML CONCENTRATO PER SOLUZIONE INIETTABILE O PER INFUSIONE 5 FLACONCINI IN VETRO DA 2 ML
INN or Proposed INN: FLUDARABINA FOSFATO
Other descriptive name: FLUDARABINA FOSFATO
Trade Name: MABTHERA - 2 FIALE 100 MG 10 ML
INN or Proposed INN: RITUXIMAB
Other descriptive name: RITUXIMAB
Trade Name: MYELOSTIM - 34 1 FLACONCINO LIOFILIZZATO 33.6 MIU + SIRINGA PRERIEMPITA SOLVENTE 1 ML
INN or Proposed INN: LENOGRASTIM
Other descriptive name: LENOGRASTIM
Trade Name: MOZOBIL - 20 MG/ML - SOLUZIONE INIETTABILE - USO SOTTOCUTANEO - F
OSPEDALE SAN RAFFAELENULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
6Phase 1Italy

57. 特発性拡張型心筋症


臨床試験数 : 12 薬物数 : 25 - (DrugBank : 12) / 標的遺伝子数 : 9 - 標的パスウェイ数 : 34
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1EUCTR2009-013112-12-GB
(EUCTR)
22/04/201017/03/2010Randomised Controlled Trial To Compare The effects of G-CSF(Granocyte™) And Autologous Bone Marrow Progenitor Cells On Quality Of Life And Left Ventricular Function In Patients with Idiopathic Dilated Cardiomyopathy - REGENERATE-DCMRandomised Controlled Trial To Compare The effects of G-CSF(Granocyte™) And Autologous Bone Marrow Progenitor Cells On Quality Of Life And Left Ventricular Function In Patients with Idiopathic Dilated Cardiomyopathy - REGENERATE-DCM Idiopathic Dilated Cardiomyopathy
Level: LLTClassification code 10056419Term: Dilated Cardiomyopathy
Trade Name: Granocyte Lenograstim
Product Name: GRANOCYTE - 34 million IU (Lenograstim rHuG-CSF)
Product Code: PL 12185/0002 & PL 12185/0005(WATER FOR INJECTION)
Barts & the London NHS TrustNULLNot RecruitingFemale: yes
Male: yes
United Kingdom

65. 原発性免疫不全症候群


臨床試験数 : 482 薬物数 : 661 - (DrugBank : 119) / 標的遺伝子数 : 90 - 標的パスウェイ数 : 211
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1EUCTR2015-002356-27-IT
(EUCTR)
16/10/201529/07/2015Evaluation of safety and efficacy of the combination of Ibuprofen (IBU), G-CSF and Plerixafor as a stem cell mobilization regimen in patients affected by XCGDA multicentric, exploratory, non-randomised, non-controlled, prospective, open-label phase II, study evaluating safety and efficacy of IBU, G-CSF and Plerixafor as a stem cell mobilization regimen in patients affected by X-CGD. X-linked chronic granulomatous disease
MedDRA version: 18.0;Level: PT;Classification code 10008906;Term: Chronic granulomatous disease;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Ibuprofen
INN or Proposed INN: IBUPROFEN
Other descriptive name: NA
Trade Name: MYELOSTIM 34 milions UI/ml, powder and solvent for solution for injection or infusion
Product Name: MYELOSTIM 34 milions UI/ml - powder and solvent for solution for injection/infusion
INN or Proposed INN: LENOGRASTIM
Trade Name: Mozobil 20mg/mL vial (injectable solution for subcutaneous use)
Product Name: Mozobil 20mg/mL vial (injectable solution, subcutaneous use)
INN or Proposed INN: Plerixafor
Other descriptive name: Plerixafor
Product Name: Pantoprazolo 20 mg gastro-resistant tablets
INN or Proposed INN: Pantoprazole
Other descriptive name: PANTOPRAZOLE
Ospedale San RaffaeleNULLAuthorised-recruitment may be ongoing or finishedFemale: no
Male: yes
3Phase 2Italy
2EUCTR2009-017346-32-IT
(EUCTR)
15/03/201026/04/2010HAEMATOPOIETIC STEM CELL GENE THERAPYA PHASE I/II CLINICAL TRIAL OF HAEMATOPOIETIC STEM CELL GENE THERAPY FOR THE WISKOTT-ALDRICH SYNDROME - TIGET-WAS Wiskott-Aldrich Syndrom
MedDRA version: 20.0;Level: PT;Classification code 10061598;Term: Immunodeficiency;System Organ Class: 10021428 - Immune system disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Trade Name: FLUDARABINA TEVA - 25 MG/ML CONCENTRATO PER SOLUZIONE INIETTABILE O PER INFUSIONE 1 FLACONCINO DI VETRO DA 2 ML
Product Name: na
Product Code: [na]
INN or Proposed INN: FLUDARABINA
Other descriptive name: FLUDARABINA
Trade Name: MOZOBIL - 20 MG/ML - SOLUZIONE INIETTABILE - USO SOTTOCUTANEO - FLACONCINO (VETRO) - 24 MG/1.2 ML 1 FLACONCINO
Product Name: PLERIXAFOR
Product Code: [na]
INN or Proposed INN: PLERIXAFOR
Other descriptive name: Plerixafor
Trade Name: MYELOSTIM - 34 1 FLACONCINO LIOFILIZZATO 33.6 MIU + SIRINGA PRERIEMPITA SOLVENTE 1 ML
Product Name: na
Product Code: [na]
INN or Proposed INN: LENOGRASTIM
Trade Name: MABTHERA - 2 FIALE 100 MG 10 ML
Product Name: RITUXIMAB
Product Code: [na]
INN or Proposed INN: RITUXIMAB
Other descriptive name: RITUXIMAB
Trade Name: BUSILVEX - 6 MG/ML - CONCENTRATO PER SOLUZIONE PER INFUSIONE - USO ENDOVENOSO - FLACONCINO - 10 ML 8 FLACONCINI
Product Name: na
Product Code: [na]
Orchard Therapeutics (Europe) LtdNULLAuthorised-recruitment may be ongoing or finishedFemale: no
Male: yes
8Phase 1;Phase 2Italy