Prevenar 13 ( DrugBank: - )


5 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
46悪性関節リウマチ2
96クローン病2
222一次性ネフローゼ症候群2

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
1EUCTR2019-001829-26-IT
(EUCTR)
19/06/202022/01/2021A 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. - NA 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 - 300 MG CONCENTRATO PER SOLUZIONE PER INFUSIONE - USO ENDOVENOSO 1 FLACONCINO (VETRO) 30 ML (10 MG/ML)
Product Name: Soliris
Product Code: [Soliris]
INN or Proposed INN: ECULIZUMAB
Trade Name: MENVEO
Product Name: MENVEO
Product Code: [NA]
Other descriptive name: N. MENINGITIDIS GROUP W135 OLIGOSACCHARIDE CONJUGATED CRM197
Trade Name: Bexsero
Product Name: Bexsero
Product Code: [NA]
Other descriptive name: RECOMBINANT NEISSERIA MENINGITIDIS GROUP B NHBA FUSION PROTEIN
Trade Name: Hiberix
Product Name: Hiberix
Product Code: [NA]
Other descriptive name: HAEMOPHILUS TYPE B CONJUGATE VACCINE (TETANUS TOXOID CONJUGATE)
Trade Name: Prevenar 13
Product Name: Prevenar 13
Product Code: [NA]
Other descriptive name: PNEUMOCOCCAL POLYSACCHARIDE CONJUGATE VACCINE (13-VALENT, ADSORBED)
ALEXION PHARMACEUTICALS INCORPORATEDNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
15Phase 2;Phase 3United States;Canada;Spain;Germany;Japan;Italy;Korea, Republic of

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

46. 悪性関節リウマチ


臨床試験数 : 4,356 薬物数 : 2,567 - (DrugBank : 415) / 標的遺伝子数 : 192 - 標的パスウェイ数 : 228
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1EUCTR2014-001299-79-DK
(EUCTR)
06/10/201407/07/2014Pnemococcal vaccination of rheumatoid arthritis patients in biological treatmentPneumococcal vaccination of rheumatoid arthritis patients in immunomodulatory therapy - Immunovax_RA Immunoresponse on pneumococcal vaccination of rheumatoid arthritis patients in immunomodulatory therapy
MedDRA version: 18.0;Level: LLT;Classification code 10069594;Term: Pneumococcal immunization;System Organ Class: 100000004865;Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]
Trade Name: Prevenar 13
INN or Proposed INN: pneumococcal polysaccharide serotype 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F
Other descriptive name: PNEUMOCOCCAL POLYSACCHARIDE CONJUGATE VACCINE (13-VALENT, ADSORBED) CONJUGATED TO CRM197 CARRIER PROTEIN AND ADSORBED ON ALUMINIUM PHOSPHATE
Trade Name: Pneumovax
INN or Proposed INN: pneumococcal polysaccharide serotype 1, 2, 3, 4, 5, 6B, 7F, 8, 9N, 9V, 10A, 11A, 12F, 14, 15B, 17F, 18C, 19A, 19F, 20, 22F, 23F and 33F
Other descriptive name: PNEUMOCOCCAL POLYSACCHARIDE VACCINE (23 VALENT)
Department of Infectious Diseases, Odense University HospitalNULLNot RecruitingFemale: yes
Male: yes
Phase 3Denmark
2NCT01942174
(ClinicalTrials.gov)
September 27, 201310/9/2013VACcination In Methotrexate Treated Rheumatoid Arthritis PatientsLead Time of the Methotrexate Establishment and Vaccinal Protection Against the Pneumococcal Agent in Patients Affected With Rheumatoid PolyarthritisRheumatoid ArthritisBiological: Prevenar 13;Biological: Pneumo23 / Pneumovax;Drug: Methotrexate - Immediate;Drug: Methotrexate - DelayUniversity Hospital, MontpellierHôpital Cochin;PfizerCompleted18 YearsN/AAll276Phase 3France;Monaco

96. クローン病


臨床試験数 : 2,442 薬物数 : 1,278 - (DrugBank : 248) / 標的遺伝子数 : 142 - 標的パスウェイ数 : 209
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1NCT01947010
(ClinicalTrials.gov)
July 20139/9/2013Pneumococcal Vaccination of Crohn PatientsPneumococcal Vaccination of Crohn Patients - A Randomized, Non-blinded Phase 4 Clinical Trial With the Purpose of Investigating the Immune Response Against Two Different Pneumococcal Vaccines in Patients With Crohn's DiseaseCrohns DiseaseBiological: Prevenar 13;Biological: PneumovaxStatens Serum InstitutHvidovre University Hospital;Herlev HospitalCompleted18 YearsN/ABoth151Phase 4Denmark
2EUCTR2012-002867-86-DK
(EUCTR)
13/02/201312/02/2013Prevention of serious pneumococcal infections in people with Crohn's diseasePneumococcal vaccination of Crohn patients - A randomized, non-blinded phase 4 clinical trial with the purpose of investigating the immune response against two different pneumococcal vaccines in patients with Crohn's disease - PneuVac Crohn's Disease
MedDRA version: 15.1;Level: LLT;Classification code 10069594;Term: Pneumococcal immunization;System Organ Class: 100000004865;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Trade Name: Pnemovax
Product Name: Pneumovax
Trade Name: Prevenar 13
Product Name: Prevenar 13
Statens Serum InstitutNULLNot RecruitingFemale: yes
Male: yes
Phase 4Denmark

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
1EUCTR2020-002637-15-IT
(EUCTR)
09/04/202104/06/2021Phase 2, multicenter, open-label, randomized, controlled study is designed to evaluate the safety and efficacy of APL-2 in patients who have post-transplant recurrence of C3G or IC-MPGNAn Open-Label, Randomized, Controlled, Phase 2 Study to Evaluate the Safety and Efficacy of Pegcetacoplan in the Treatment of Post-Transplant Recurrenceof C3G or IC-MPGN - NOBLE complement 3 glomerulopathy (C3G)/immune complex membranoproliferative glomerulonephritis (IC-MPGN)
MedDRA version: 20.1;Level: LLT;Classification code 10063210;Term: Transplant glomerulopathy;System Organ Class: 100000004870;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Pegcetacoplan
Product Code: [APL-2]
INN or Proposed INN: Pegcetacoplan
Trade Name: Prevenar 13 suspension for injection
Product Name: Prevenar 13 suspension for injection
Product Code: [na]
INN or Proposed INN: Pneumococcal polysaccharide serotype 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F
Other descriptive name: Pneumococcal polysaccharide serotype 11 2.2 µg
Trade Name: Pneumococcal polysaccharide vaccine
Product Name: Pneumococcal polysaccharide vaccine solution for injection in a vial
Product Code: [na]
INN or Proposed INN: Pneumococcal Polysaccharide Vaccine
Other descriptive name: The 0.5 mL dose of vaccine contains 25 micrograms of each of the following 23 pneumococcal polysaccharide
APELLIS PHARMACEUTCIALS, INC.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
12Phase 2France;Argentina;Spain;Brazil;Austria;Australia;Netherlands;United Kingdom;Switzerland;Italy;United States
2EUCTR2017-002674-39-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