Intratect ( DrugBank: - )

4 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
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
35天疱瘡1
65原発性免疫不全症候群4

13. 多発性硬化症／視神経脊髄炎

臨床試験数 : 3,342 /  薬物数 : 2,355 - (DrugBank : 406) / 標的遺伝子数 : 269 - 標的パスウェイ数 : 241
No.TrialIDDate_
enrollment		Date_
registration		Public_titleScientific_titleConditionInterventionPrimary_
sponsor		Secondary_
sponsor		Recruitment_
Status		Inclusion_
agemin		Inclusion_
agemax		Inclusion_
gender		Target_
size		PhaseCountries
1EUCTR2014-002335-34-GB
(EUCTR)		30/10/201423/10/2014Intravenous immunoglobulin vs standard therapy for treatment of transverse myelitisA multicentre randomiSed controlled TRial of IntraVEnous immunoglobulin (IVIg) versus standard therapy for the treatment of transverse myelitis in adults and children - STRiVE Transverse myelitis (TM) (acute, first onset cases), including first presentation of neuromyelitis optica (NMO)
MedDRA version: 17.1;Level: PT;Classification code 10028527;Term: Myelitis transverse;System Organ Class: 10029205 - Nervous system disorders
MedDRA version: 17.1;Classification code 10029322;Term: Neuromyelitis optica;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Body processes [G] - Immune system processes [G12]		Trade Name: Intratect
Product Name: Intratect		Guy's and St Thomas NHS Foundation TrustNULLNot RecruitingFemale: yes
Male: yes		0Phase 3United Kingdom

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 : 167 /  薬物数 : 158 - (DrugBank : 38) / 標的遺伝子数 : 13 - 標的パスウェイ数 : 23
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

35. 天疱瘡

臨床試験数 : 98 /  薬物数 : 126 - (DrugBank : 41) / 標的遺伝子数 : 23 - 標的パスウェイ数 : 168
No.TrialIDDate_
enrollment		Date_
registration		Public_titleScientific_titleConditionInterventionPrimary_
sponsor		Secondary_
sponsor		Recruitment_
Status		Inclusion_
agemin		Inclusion_
agemax		Inclusion_
gender		Target_
size		PhaseCountries
1EUCTR2013-000211-24-DE
(EUCTR)		01/10/201308/07/2013immunoglobulin infusion as adjuvant therapy in patients with Pemphigus VulgarisA multicenter, randomized, placebo-controlled, double-blind proof of concept study to evaluate the efficacy and safety of the human normal immunoglobulin Intratect® 5% for intravenous use as adjuvant therapy in patients with Pemphigus Vulgaris - IMAT-PV patients with Pemphigus vulgaris
MedDRA version: 16.0;Level: LLT;Classification code 10052802;Term: Pemphigus vulgaris;System Organ Class: 100000004858 ;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]		Trade Name: Intratect 5%
Product Name: Intratect
Other descriptive name: WATER FOR INJECTION
Other descriptive name: GLYCINE		Ruprecht-Karls-University HeidelbergNULLNot Recruiting Female: yes
Male: yes		10 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): noGermany

65. 原発性免疫不全症候群

臨床試験数 : 482 /  薬物数 : 653 - (DrugBank : 119) / 標的遺伝子数 : 92 - 標的パスウェイ数 : 212
No.TrialIDDate_
enrollment		Date_
registration		Public_titleScientific_titleConditionInterventionPrimary_
sponsor		Secondary_
sponsor		Recruitment_
Status		Inclusion_
agemin		Inclusion_
agemax		Inclusion_
gender		Target_
size		PhaseCountries
1EUCTR2010-019249-25-HU
(EUCTR)		22/09/201006/08/2010Eine offene, prospektive Studie zur Untersuchung der Pharmakokinetikund Sicherheit (Teil A) des Immunglobulins vom Menschen zurintravenösen Infusion (IVIG) BT090 sowie der Verträglichkeit undSicherheit von steigenden Infusionsgeschwindigkeiten (Teil B) beiPatienten mit primären Immundefekten (PID)An open, prospective trial investigating pharmacokinetics and safety (Part A) of the human normal immunoglobulin for intravenous infusion (IVIG) BT090 and tolerability and safety of escalating infusion rates (Part B) in patients with primary immunodeficiency disease (PID) Primary immunodeficiency disease (PID)
MedDRA version: 13.1;Level: LLT;Classification code 10010509;Term: Congenital hypogammaglobulinemia;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]		Product Name: Intratect
Product Code: BT090
Other descriptive name: Human normal immunoglobulin for intravenous use (IVIG)		Biotest AGNULLNot RecruitingFemale: yes
Male: yes		30Hungary;Germany
2EUCTR2010-019249-25-DE
(EUCTR)		12/08/201014/05/2010An open, prospective trial investigating pharmacokinetics and safety (Part A) of the human normal immunoglobulin for intravenous infusion (IVIG) BT090 and tolerability and safety of escalating infusion rates (Part B) in patients with primary immunodeficiency disease (PID)An open, prospective trial investigating pharmacokinetics and safety (Part A) of the human normal immunoglobulin for intravenous infusion (IVIG) BT090 and tolerability and safety of escalating infusion rates (Part B) in patients with primary immunodeficiency disease (PID) Primary immunodeficiency disease (PID)
MedDRA version: 14.1;Level: LLT;Classification code 10010509;Term: Congenital hypogammaglobulinemia;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]		Product Name: Intratect
Product Code: BT090
Other descriptive name: Human normal immunoglobulin for intravenous use (IVIG)		Biotest AGNULLNot RecruitingFemale: yes
Male: yes		30Hungary;Germany
3EUCTR2004-004465-15-HU
(EUCTR)		22/07/200511/05/2005A multicentre, open, prospective study investigating clinical efficacy, safety, and pharmacokinetic properties of the human normal immunoglobulin for intravenous administration BT681 in patients with primary immunodeficiency disease (PID)A multicentre, open, prospective study investigating clinical efficacy, safety, and pharmacokinetic properties of the human normal immunoglobulin for intravenous administration BT681 in patients with primary immunodeficiency disease (PID) primary immunodeficiency syndrome as congenital agammaglobulinaemia or hypogammaglobulinaemia, common variable immunodeficiency, severe combined immunodeficiencies, Wiskott Aldrich syndrome
MedDRA version: 7.0;Level: HLT;Classification code 10036700		Trade Name: Intratect
Product Name: Intratect
Product Code: BT681
Other descriptive name: human normal immunoglobulin (IVIg)		Biotest AGNULLNot RecruitingFemale: yes
Male: yes		50Hungary;Germany
4EUCTR2004-004465-15-DE
(EUCTR)		05/04/200504/02/2005A multicentre, open, prospective study investigating clinical efficacy, safety, and pharmacokinetic properties of the human normal immunoglobulin for intravenous administration BT681 in patients with primary immunodeficiency disease (PID)A multicentre, open, prospective study investigating clinical efficacy, safety, and pharmacokinetic properties of the human normal immunoglobulin for intravenous administration BT681 in patients with primary immunodeficiency disease (PID) primary immunodeficiency syndrome as congenital agammaglobulinaemia or hypogammaglobulinaemia, common variable immunodeficiency, severe combined immunodeficiencies, Wiskott Aldrich syndrome
MedDRA version: 7.0;Level: HLT;Classification code 10036700		Product Name: Intratect
Product Code: BT681
Other descriptive name: human normal immunoglobulin (IVIg)		Biotest AGNULLNot RecruitingFemale: yes
Male: yes		50Hungary;Germany

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