Act-HiB ( DrugBank: - )


4 diseases
告示番号疾患名(ページ内リンク)臨床試験数
14慢性炎症性脱髄性多発神経炎/多巣性運動ニューロパチー1
61自己免疫性溶血性貧血1
62発作性夜間ヘモグロビン尿症2
222一次性ネフローゼ症候群1

14. 慢性炎症性脱髄性多発神経炎/多巣性運動ニューロパチー


臨床試験数 : 175 薬物数 : 161 - (DrugBank : 41) / 標的遺伝子数 : 13 - 標的パスウェイ数 : 24
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1EUCTR2021-003302-50-IT
(EUCTR)
17/02/202226/11/2021A clinical trial to investigate the safety and tolerability, efficacy pharmacokinetics, pharmacodynamics, and immunogenicity of 2 dose regimens of ARGX-117 in adults with multifocal motor neuropathyA Phase 2, Randomized, Double-Blinded, Placebo-Controlled, Parallel- Group, Multicenter Trial to Evaluate the Safety and Tolerability, Efficacy,Pharmacokinetics, Pharmacodynamics, and Immunogenicity of 2 Dose Regimens of ARGX-117 in Adults With Multifocal Motor Neuropathy - ARDA Multifocal Motor Neuropathy
MedDRA version: 21.1;Level: PT;Classification code 10065579;Term: Multifocal motor neuropathy;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: ARGX-117 IV
Product Code: [ARGX-117 IV]
Trade Name: Act-HiB
Product Name: Haemophilus type b vaccine (conjugated)
Product Code: [.]
Other descriptive name: HAEMOPHILUS TYPE B CONJUGATE VACCINE (TETANUS TOXOID CONJUGATE)
Trade Name: Intratect
Product Name: Human normal immunoglobulin (IVIg)
Product Code: [-]
INN or Proposed INN: Human normal immunoglobulin (IVIg)
Other descriptive name: HUMAN NORMAL IMMUNOGLOBULIN (IV)
Trade Name: Menjugate
Product Name: Group C meningococcal conjugate vaccine
Product Code: [J07AH07]
INN or Proposed INN: Group C meningococcal conjugate vaccine
Other descriptive name: N. MENINGITIDIS GROUP C POLYSACCHARIDE
Trade Name: Prevenar 13 sospensione per iniezione
Product Name: pneumococcal polysaccharide conjugate vaccine (13-valent, adsorbed)
Product Code: [NA]
INN or Proposed INN: VACCINO PNEUMOCOCCICO SACCARIDICO
ARGENX BVNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
48Phase 2France;United States;Canada;Spain;Poland;Belgium;Denmark;Austria;Netherlands;Germany;United Kingdom;Italy

61. 自己免疫性溶血性貧血


臨床試験数 : 146 薬物数 : 131 - (DrugBank : 59) / 標的遺伝子数 : 28 - 標的パスウェイ数 : 158
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1EUCTR2021-002039-40-IT
(EUCTR)
08/02/202201/10/2021Basket study to assess efficacy, safety and PK of iptacopan (LNP023) in autoimmune benign hematological disordersAn open-label, multi-center, phase 2 basket study to assess efficacy, safety and pharmacokinetics of iptacopan (LNP023) in participants with autoimmune benign hematological disorders - -- Immune thrombocytopenia (ITP)Cold agglutinin disease (CAD)
MedDRA version: 23.0;Level: PT;Classification code 10083842;Term: Immune thrombocytopenia;System Organ Class: 10005329 - Blood and lymphatic system disorders
MedDRA version: 20.0;Level: LLT;Classification code 10068863;Term: Cold agglutinin disease;System Organ Class: 10005329 - Blood and lymphatic system disorders;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]
Trade Name: ACT-HIB Polvere e solvente per soluzione iniettabile in siringa preriempita 0,5 ml
Product Name: -
Product Code: [-]
INN or Proposed INN: HAEMOPHILUS INFLUENZAE
Trade Name: BEXSERO – Sospensione iniettabile – Siringa preriempita
Product Name: -
Product Code: [-]
INN or Proposed INN: VACCINO CONTRO IL MEMINGOCOCCO DI GRUPPO B
Trade Name: HIBERIX - POLVERE E SOLVENTE PER SOLUZIONE INIETTABILE PER USO INTRAMUSCOLARE 1 FLACONCINO DI POLVERE + 1 SIRINGA PRERIEMPITA DI SOLVENTE DA 0.5 ML
Product Name: -
Product Code: [-]
INN or Proposed INN: VACCINO HAEMOPHILUS INFLUENZAE B CONIUGATO CON TOSSOIDETETANICO
Trade Name: MENVEO – Polvere e soluzione per soluzione iniettabile
Product Name: -
Product Code: [-]
INN or Proposed INN: VACCINO POLISACCARIDICO ANTI-MENINGOCOCCICO (A.C.Y E W-135)
Trade Name: Nimenrix
Product Name: -
Product Code: [-]
INN or Proposed INN: VACCINO POLISACCARIDICO ANTI-MENINGOCOCCICO (A.C.Y E W-135)
NOVARTIS PHARMA AGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
30Phase 2United States;Spain;Korea, Democratic People's Republic of;Germany;United Kingdom;Italy

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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1EUCTR2020-003172-41-IT
(EUCTR)
20/07/202117/08/2021Study of Efficacy and Safety of Twice Daily Oral LNP023 in Adult PNH Patients who are naïve to complement inhibitor therapy.A multicenter, single-arm, open-label trial to evaluate efficacy and safety of oral, twice daily iptacopan in adult PNH patients who are naive to complement inhibitor therapy. - - Paroxysmal Nocturnal Hemoglobinuria (PNH).
MedDRA version: 21.1;Level: PT;Classification code 10034042;Term: Paroxysmal nocturnal haemoglobinuria;System Organ Class: 10038359 - Renal and urinary disorders;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]
Trade Name: HIBERIX - POLVERE E SOLVENTE PER SOLUZIONE INIETTABILE PER USO INTRAMUSCOLARE 1 FLACONCINO DI POLVERE + 1 SIRINGA PRERIEMPITA DI SOLVENTE DA 0.5 ML
Product Name: -
Product Code: [-]
INN or Proposed INN: VACCINO HAEMOPHILUS INFLUENZAE B CONIUGATO CON TOSSOIDETETANICO
Trade Name: MENVEO – Polvere e soluzione per soluzione iniettabile
Product Name: -
Product Code: [-]
INN or Proposed INN: VACCINO POLISACCARIDICO ANTI-MENINGOCOCCICO (A.C.Y E W-135)
Trade Name: PNEUMOVAX – Soluzione iniettabile in siringa preriempita da 0,5 ml
Product Name: -
Product Code: [-]
INN or Proposed INN: VACCINO PNEUMOCOCCICO
Trade Name: BEXSERO – Sospensione iniettabile – Siringa preriempita
Product Name: -
Product Code: [-]
INN or Proposed INN: VACCINO CONTRO IL MEMINGOCOCCO DI GRUPPO B
Trade Name: ACT-HIB Polvere e solvente per soluzione iniettabile in siringa preriempita 0,5 ml
Product Name: -
Product Code: [-]
INN or Proposed INN: HAEMOPHILUS INFLUENZAE
NOVARTIS PHARMA AGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
40Phase 3France;United States;Czechia;Malaysia;Singapore;Germany;United Kingdom;Japan;China;Italy;Korea, Republic of
2EUCTR2019-004665-40-IT
(EUCTR)
23/12/202015/06/2021Study of efficacy and safety of twice daily oral LNP023 in adult PNH patients with residual anemia despite anti-C5 antibody treatmentA randomized, multicenter, active-comparator controlled, open-label trial to evaluate efficacy and safety of oral, twice daily LNP023 in adult patients with PNH and residual anemia, despite treatment with an intravenous anti-C5 antibody - Study of efficacy and safety of twice daily oral LNP023 in adult PNH patients with residual anemia d Paroxysmal Nocturnal Hemoglobinuria (PNH)
MedDRA version: 21.1;Level: PT;Classification code 10034042;Term: Paroxysmal nocturnal haemoglobinuria;System Organ Class: 10038359 - Renal and urinary disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Iptacopan
Product Code: [LNP023]
INN or Proposed INN: Iptacopan
Other descriptive name: LNP023 HYDROCHLORIDE SALT
Product Name: Iptacopan
Product Code: [LNP023]
INN or Proposed INN: Iptacopan
Other descriptive name: LNP023 HYDROCHLORIDE SALT
Trade Name: Soliris
Product Name: Eculizumab
Product Code: [-]
INN or Proposed INN: ECULIZUMAB
Trade Name: ACT-HIB Polvere e solvente per soluzione iniettabile in siringa preriempita 0,5 ml
Product Name: -
Product Code: [-]
INN or Proposed INN: HAEMOPHILUS INFLUENZAE
Trade Name: MENVEO – Polvere e soluzione per soluzione iniettabile
Product Name: -
Product Code: [-]
INN or Proposed INN: VACCINO POLISACCARIDICO ANTI-MENINGOCOCCICO (A.C.Y E W-135)
Trade Name: PNEUMOVAX – Soluzione iniettabile in siringa preriempita da 0,5 ml
Product Name: -
Product Code: [-]
INN or Proposed INN: VACCINO PNEUMOCOCCICO
NOVARTIS PHARMA AGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
91Phase 3United States;Czechia;Taiwan;Spain;Korea, Democratic People's Republic of;Italy;United Kingdom;France;Hungary;Canada;Brazil;Germany;Netherlands;Japan

222. 一次性ネフローゼ症候群


臨床試験数 : 310 薬物数 : 295 - (DrugBank : 117) / 標的遺伝子数 : 63 - 標的パスウェイ数 : 194
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1EUCTR2017-002674-39-IT
(EUCTR)
03/08/201808/06/2021A treatment study of ACH-0144471 in Patients with C3 Glomerulopathy (C3G) or Immune-Complex Membranoproliferative Glomerulonephritis (ICMPGN)An Open-Label Phase 2 Proof-of-Concept Study in Patients with C3 Glomerulopathy (C3G) or Immune-Complex Membranoproliferative Glomerulonephritis (IC-MPGN) Treated with ACH-0144471 - N/A C3 Glomerulopathy (C3G) or idiopathic Immune-Complex Membranoproliferative Glomerulonephritis (IC-MPGN)
MedDRA version: 20.1;Level: PT;Classification code 10018364;Term: Glomerulonephritis;System Organ Class: 10038359 - Renal and urinary disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: ACH-0144471 compresse
Product Code: ACH-0144471
INN or Proposed INN: ACH-0144471
Product Name: ACH-0144471 compresse
Product Code: ACH-0144471
INN or Proposed INN: ACH-0144471
Product Name: ACH0144471 compresse
Product Code: ACH0144471
INN or Proposed INN: ACH-0144471
Trade Name: TETRACT-HIB - 1 SIRINGA PRECARICATA 0.5 ML
Product Name: ACT-HIB
Product Code: [ACT-HIB]
Product Name: Bexsero
Product Code: [Bexsero]
Product Name: Menveo
Product Code: [Menveo]
Trade Name: PREVENAR 13 - 0.5 ML SOSPENSIONE INIETTABILE - USO INTRAMUSCOLARE - FLACONCINO MONODOSE (0,5 ML VETRO TIPO I) - 1 FLACONCINO MONODOSE
Product Name: Prevenar 13
Product Code:
ACHILLION PHARMACEUTICALS, INC.NULLNot RecruitingFemale: yes
Male: yes
20Phase 2United States;Belgium;Australia;Netherlands;Italy