CETIRIZINA ( DrugBank: Cetirizina )

3 diseases
告示番号疾患名（ページ内リンク）臨床試験数
13多発性硬化症／視神経脊髄炎1
28全身性アミロイドーシス1
300IgG4関連疾患1

13. 多発性硬化症／視神経脊髄炎

臨床試験数 : 3,340 /  薬物数 : 2,163 - (DrugBank : 383) / 標的遺伝子数 : 241 - 標的パスウェイ数 : 238
No.TrialIDDate_
enrollment		Date_
registration		Public_titleScientific_titleConditionInterventionPrimary_
sponsor		Secondary_
sponsor		Recruitment_
Status		Inclusion_
agemin		Inclusion_
agemax		Inclusion_
gender		Target_
size		PhaseCountries
1EUCTR2013-001055-12-IT
(EUCTR)		28/05/201503/06/2013Study to evaluate the efficacy of cetirizine in the treatment of Flu-like syndrome (FLS) in patients with multiple sclerosis treated with interferoneß.Flu-like syndrome Inhibition Giving anti-histaminic Therapy. Randomized cross-over, single-center, randomized, placebo-controlled, double-blind study to evaluate the efficacy of cetirizine on Flu-like syndrome (FLS) in patients with multiple sclerosis treated with interferoneß. - FLU-LIGHT Patients with relapsing remitting multiple sclerosis (RRMS) treated with interferoneß, suffering from flu-like syndrome (FLS).
MedDRA version: 16.0;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]		Trade Name: Cetirizina Mylan Generics
Product Name: Cetirizina Mylan Generics
INN or Proposed INN: Cetirizina
Other descriptive name: CETIRIZINE HYDROCHLORIDE		Biogen Idec Italia S.r.l.NULLNot RecruitingFemale: yes
Male: yes		Italy

28. 全身性アミロイドーシス

臨床試験数 : 267 /  薬物数 : 241 - (DrugBank : 77) / 標的遺伝子数 : 68 - 標的パスウェイ数 : 180
No.TrialIDDate_
enrollment		Date_
registration		Public_titleScientific_titleConditionInterventionPrimary_
sponsor		Secondary_
sponsor		Recruitment_
Status		Inclusion_
agemin		Inclusion_
agemax		Inclusion_
gender		Target_
size		PhaseCountries
1EUCTR2021-000037-14-IT
(EUCTR)		21/01/202226/11/2021A Global Phase 3 Double-Blind, Placebo-Controlled study to assess Efficacy and Safety of Birtamimab Plus Standard of Care vs. Placebo Plus Standardof Care in Mayo Stage IV Subjects with Light Chain (AL) AmyloidosisA Phase 3, Randomized, Multicenter, Double-Blind, Placebo-Controlled, Efficacy and Safety Study of Birtamimab Plus Standard of Care vs. PlaceboPlus Standard of Care in Mayo Stage IV Subjects with Light Chain (AL) Amyloidosis - NA AL amyloidosis involves a hematologic disorder caused by clonal plasma cells that produce misfolded immunoglobulin light chains.Overproduction of misfolded light chains results in both soluble, aggregated forms of light chains and insoluble, fibrillar deposits ofabnormal AL protein (amyloid), in the tissues and organs. This can cause a range of symptoms and organ dysfunction including cardiac, renal, andhepatic dysfunction, gastrointestinal involvement and neuropathy and macroglossia
MedDRA version: 20.0;Level: PT;Classification code 10036673;Term: Primary amyloidosis;System Organ Class: 10021428 - Immune system disorders;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]		Product Name: Birtamimab
Product Code: [Birtamimab]
INN or Proposed INN: BIRTAMIMAB
Other descriptive name: Humanized IgG1 kappa antiamyloid
Product Name: paracetamolo Zentiva Italia
Product Code: [NA]
INN or Proposed INN: PARACETAMOLO
Trade Name: Bortezomib Accord
Product Name: Bortezomib Accord
Product Code: [Bortezomib Accord]
INN or Proposed INN: BORTEZOMIB
Other descriptive name: Bortezomib D-mannitol
Product Name: Zirtec
Product Code: [NA]
INN or Proposed INN: CETIRIZINA DICLORIDRATO
Other descriptive name: NA
Product Name: Aciclin
Product Code: [NA]
INN or Proposed INN: ACICLOVIR		Prothena Biosciences LimitedNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes		150Phase 3United States;Portugal;Czechia;Taiwan;Greece;Spain;Turkey;Israel;United Kingdom;Italy;France;Hungary;Canada;Poland;Brazil;Australia;Denmark;Germany;Netherlands;Korea, Republic of

300. IgG4関連疾患

臨床試験数 : 40 /  薬物数 : 47 - (DrugBank : 21) / 標的遺伝子数 : 18 - 標的パスウェイ数 : 141
No.TrialIDDate_
enrollment		Date_
registration		Public_titleScientific_titleConditionInterventionPrimary_
sponsor		Secondary_
sponsor		Recruitment_
Status		Inclusion_
agemin		Inclusion_
agemax		Inclusion_
gender		Target_
size		PhaseCountries
1EUCTR2020-000417-33-IT
(EUCTR)		16/12/202021/10/2020Inebilizumab efficacy and safety in IgG4 related diseaseA Phase 3, Randomized, Double-blind, Multicenter, Placebo-Controlled Study of Inebilizumab Efficacy and Safety in IgG4 Related Disease(short title: MITIGATE – InebilizuMab effIcacy and safeTy in IGg4 relATed disEase) - MITIGATE Immunoglobulin G4-related disease (IgG4-RD)
MedDRA version: 20.0;Level: PT;Classification code 10077271;Term: Immunoglobulin G4 related disease;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]		Product Name: Inebilizumab
Product Code: [Inebilizumab]
INN or Proposed INN: Inebilizumab
Other descriptive name: afucosylated IgG1 kappa monoclonal antibody
Trade Name: PREDNISONE DOC GENERICI - 5 MG COMPRESSE 30 COMPRESSE IN BLISTER PVC-PVDC/ALU
Product Name: Prednisone
Product Code: [Prednisone]
INN or Proposed INN: PREDNISONE
Trade Name: CETIRIZINA SANDOZ - 10 MG COMPRESSE RIVESTITE CON FILM 20 COMPRESSE IN BLISTER PVC/ALU
Product Name: Cetirizina
Product Code: [Cetirizina]
INN or Proposed INN: CETIRIZINA
Trade Name: PARACETAMOLO NOVA ARGENTIA - 500 MG COMPRESSE 20 COMPRESSE
Product Name: Paracetamolo
Product Code: [Paracetamolo]
INN or Proposed INN: PARACETAMOLO
Trade Name: METILPREDNISOLONE HIKMA - 1000 MG POLVERE PER SOLUZIONE INIETTABILE 10 FLACONCINI IN VETRO
Product Name: Metilprednisolone
Product Code: [Metilprednisolone]
INN or Proposed INN: METILPREDNISOLONE		VIELABIO Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes		200Phase 3United States;Spain;Ukraine;Israel;United Kingdom;Italy;India;France;Hungary;Mexico;Canada;Poland;Australia;Germany;Netherlands;China;Japan;Sweden;Korea, Republic of