HYQVIA ( DrugBank: - )


2 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4
65原発性免疫不全症候群14

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
1NCT02885259
(ClinicalTrials.gov)
September 201625/1/2016HyQvia in Multifocal Motor NeuropathySubcutaneous Immunoglobulin With rHuPH20 in Multifocal Motor NeuropathyMultifocal Motor NeuropathyDrug: rHuPH20UMC UtrechtNULLNot yet recruiting18 Years99 YearsBoth20N/ANetherlands
2EUCTR2015-000828-28-NL
(EUCTR)
26/07/201630/11/2015Immunoglobulins given under the skin to treat patients with multifocal motor neuropathy (MMN). To increase the amount of immunoglobulins, an enzyme is added that will temporarily create more space under the skin. This space is filled with immunoglobulins. By this way less infusions should be needed.Titlle: Subcutaneous immunoglobulins with rHuPH20 in multifocal motor neuropathy (MMN) It is an interventional cross-over study where the use of the combination of subcutaneous immunoglobulins together with the enzyme hyaluronidase (rHuPH20) is compared with the current gold standard intravenous immunoglobulins (IVIg). Non-inferiority and tolerability are studied in 20 MMN patients. The reason to add rHuPH20 is to increase volumes per infusion and in this way contribute to reduced frequency of infusions. - Hymne Non-inferiority and safety/tolerance of Hyqvia compared to IVIg in 20 MMN patients with at least one conduction block on EMG and stable on IVIg.;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]Trade Name: Hyqvia
Product Name: Hyqvia
UMC UtrechtNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
Phase 3Netherlands
3NCT02556437
(ClinicalTrials.gov)
June 201618/9/2015Efficacy and Safety of HyQvia (Immunoglobulin 10% With Recombinant Hyaluronidase) in Multifocal Motor Neuropathy (MMN)Randomized, Single-blind, Cross-over Study Investigating the Non-inferiority of Efficacy and Safety of HyQvia in Comparison With Conventional Subcutaneous Ig Therapy in Multifocal Motor NeuropathyMultifocal Motor NeuropathyDrug: HyQvia;Drug: SubcuviaJohannes JakobsenBaxter Healthcare CorporationCompleted18 Years90 YearsAll18Phase 2Denmark
4EUCTR2015-003453-18-DK
(EUCTR)
25/11/201523/09/2015Study of the effect and safety of a new immunoglobulin preparation (HyQvia) for subcutaneous usage in patients with Multifocal Motor NeuropathyA Randomized, Single-blinded, Cross-over Study investigating the Non-inferiority of Efficacy and Safety of HyQvia in comparison with Conventional Subcutaneous Ig Therapy in Multifocal Motor Neuropathy Multifocal Motor Neuropathy (MMN)
MedDRA version: 18.1;Level: PT;Classification code 10064135;Term: Polyneuropathy chronic;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: HyQvia
Product Name: HyQvia
INN or Proposed INN: Human normal immunoglobulin
Other descriptive name: HUMAN NORMAL IMMUNOGLOBULIN
Trade Name: Subcuvia
Product Name: Subcuvia
INN or Proposed INN: Human normal immunoglobulin
Other descriptive name: HUMAN NORMAL IMMUNOGLOBULIN
RigshospitaletNULLNot RecruitingFemale: yes
Male: yes
20Phase 2Denmark

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
1EUCTR2016-003438-26-HU
(EUCTR)
28/08/201920/06/2019Study to further assess the positive effect of the immunoglobulin product for subcutaneous use, HyQvia, in children (age <18 years) with Primary Immunodeficiency Diseases who have received prior immunoglobulin therapy before enrollment into the study.Post-Authorization Safety, Tolerability and Immunogenicity Evaluation of HyQvia in Pediatric Subjects with Primary Immunodeficiency Diseases Primary Immunodeficiency Disease (PIDD)
MedDRA version: 20.0;Level: PT;Classification code 10064859;Term: Primary immunodeficiency syndrome;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Trade Name: HyQvia 100 mg/ml solution for infusion for subcutaneous use
Product Name: HyQvia
INN or Proposed INN: Human normal immunoglobulin
Other descriptive name: HUMAN NORMAL IMMUNOGLOBULIN
Trade Name: KIOVIG 100 mg/ml solution for infusion
Product Name: KIOVIG
INN or Proposed INN: Human normal immunoglobulin
Other descriptive name: HUMAN NORMAL IMMUNOGLOBULIN (IV)
Trade Name: Cuvitru 200 mg/ml solution for subcutaneous injection
Product Name: Cuvitru
INN or Proposed INN: Human Normal Immunoglobulin
Other descriptive name: HUMAN NORMAL IMMUNOGLOBULIN
Baxalta US Inc.NULLNot RecruitingFemale: yes
Male: yes
40Phase 4France;Czech Republic;Hungary;Slovakia;Greece;Denmark;United Kingdom;Sweden
2EUCTR2016-003438-26-GR
(EUCTR)
13/11/201711/10/2017Study to further assess the positive effect of the immunoglobulin product for subcutaneous use, HyQvia, in children (age <18 years) with Primary Immunodeficiency Diseases who have received prior immunoglobulin therapy before enrollment into the study.Post-Authorization Safety, Tolerability and Immunogenicity Evaluation of HyQvia in Pediatric Subjects with Primary Immunodeficiency Diseases Primary Immunodeficiency Disease (PIDD)
MedDRA version: 20.0;Level: PT;Classification code 10064859;Term: Primary immunodeficiency syndrome;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Trade Name: HyQvia 100 mg/ml solution for infusion for subcutaneous use
Product Name: HyQvia
INN or Proposed INN: Human normal immunoglobulin
Other descriptive name: HUMAN NORMAL IMMUNOGLOBULIN
Trade Name: KIOVIG 100 mg/ml solution for infusion
Product Name: KIOVIG
INN or Proposed INN: Human normal immunoglobulin
Other descriptive name: HUMAN NORMAL IMMUNOGLOBULIN (IV)
Trade Name: Cuvitru 200 mg/ml solution for subcutaneous injection
Product Name: Cuvitru
INN or Proposed INN: Human Normal Immunoglobulin
Other descriptive name: HUMAN NORMAL IMMUNOGLOBULIN
Baxalta US Inc.NULLNot RecruitingFemale: yes
Male: yes
40Phase 4France;Hungary;Czech Republic;Slovakia;Greece;Denmark;United Kingdom;Sweden
3NCT03277313
(ClinicalTrials.gov)
September 25, 20177/9/2017Efficacy, Safety, Tolerability, Immunogenicity and Pharmacokinetic Evaluation of HYQVIA in Pediatric PIDD SubjectsEfficacy, Safety, Tolerability, Immunogenicity and Pharmacokinetic Evaluation of HYQVIA in Pediatric Subjects With Primary Immunodeficiency DiseasesPrimary Immunodeficiency Diseases (PID)Biological: HYQVIA;Biological: GAMMAGARD LIQUIDBaxalta now part of ShireBaxalta Innovations GmbH, now part of ShireActive, not recruiting2 Years15 YearsAll44Phase 3United States
4NCT03116347
(ClinicalTrials.gov)
June 13, 201712/4/2017Post-Authorization Safety, Tolerability and Immunogenicity Evaluation of HyQvia in Pediatric PIDD SubjectsPost-Authorization Safety, Tolerability and Immunogenicity Evaluation of HyQvia in Pediatric Subjects With Primary Immunodeficiency DiseasesPrimary Immunodeficiency Diseases (PID)Biological: HYQVIA;Biological: KIOVIG;Biological: CuvitruBaxalta now part of ShireBaxalta Innovations GmbH, now part of ShireCompleted2 Years17 YearsAll42Phase 4Czechia;Denmark;France;Greece;Slovakia;Sweden;United Kingdom
5EUCTR2016-003438-26-CZ
(EUCTR)
18/05/201727/01/2017Study to further assess the positive effect of the immunoglobulin product for subcutaneous use, HyQvia, in children (age <18 years) with Primary Immunodeficiency Diseases who have received prior immunoglobulin therapy before enrollment into the study.Post-Authorization Safety, Tolerability and Immunogenicity Evaluation of HyQvia in Pediatric Subjects with Primary Immunodeficiency Diseases Primary Immunodeficiency Disease (PIDD)
MedDRA version: 20.0;Level: PT;Classification code 10064859;Term: Primary immunodeficiency syndrome;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Trade Name: HyQvia 100 mg/ml solution for infusion for subcutaneous use
Product Name: HyQvia
INN or Proposed INN: Human normal immunoglobulin
Other descriptive name: HUMAN NORMAL IMMUNOGLOBULIN
Trade Name: KIOVIG 100 mg/ml solution for infusion
Product Name: KIOVIG
INN or Proposed INN: Human normal immunoglobulin
Other descriptive name: HUMAN NORMAL IMMUNOGLOBULIN (IV)
Trade Name: Cuvitru 200 mg/ml solution for subcutaneous injection
Product Name: Cuvitru
INN or Proposed INN: Human Normal Immunoglobulin
Other descriptive name: HUMAN NORMAL IMMUNOGLOBULIN
Baxalta US Inc.NULLNot RecruitingFemale: yes
Male: yes
40Phase 4France;Hungary;Czech Republic;Slovakia;Greece;Denmark;United Kingdom;Sweden
6EUCTR2016-003438-26-DK
(EUCTR)
08/05/201719/01/2017Study to further assess the positive effect of the immunoglobulin product for subcutaneous use, HyQvia, in children (age <18 years) with Primary Immunodeficiency Diseases who have received prior immunoglobulin therapy before enrollment into the study.Post-Authorization Safety, Tolerability and Immunogenicity Evaluation of HyQvia in Pediatric Subjects with Primary Immunodeficiency Diseases Primary Immunodeficiency Disease (PIDD)
MedDRA version: 20.0;Level: PT;Classification code 10064859;Term: Primary immunodeficiency syndrome;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Trade Name: HyQvia 100 mg/ml solution for infusion for subcutaneous use
Product Name: HyQvia
INN or Proposed INN: Human normal immunoglobulin
Other descriptive name: HUMAN NORMAL IMMUNOGLOBULIN
Trade Name: KIOVIG 100 mg/ml solution for infusion
Product Name: KIOVIG
INN or Proposed INN: Human normal immunoglobulin
Other descriptive name: HUMAN NORMAL IMMUNOGLOBULIN (IV)
Trade Name: Cuvitru 200 mg/ml solution for subcutaneous injection
Product Name: Cuvitru
INN or Proposed INN: Human Normal Immunoglobulin
Other descriptive name: HUMAN NORMAL IMMUNOGLOBULIN
Baxalta US Inc.NULLNot RecruitingFemale: yes
Male: yes
40Phase 4France;Hungary;Czech Republic;Slovakia;Greece;Denmark;United Kingdom;Sweden
7EUCTR2016-003438-26-FR
(EUCTR)
18/04/201721/03/2017Study to further assess the positive effect of the immunoglobulin product for subcutaneous use, HyQvia, in children (age <18 years) with Primary Immunodeficiency Diseases who have received prior immunoglobulin therapy before enrollment into the study.Post-Authorization Safety, Tolerability and Immunogenicity Evaluation of HyQvia in Pediatric Subjects with Primary Immunodeficiency Diseases Primary Immunodeficiency Disease (PIDD)
MedDRA version: 19.1;Level: PT;Classification code 10064859;Term: Primary immunodeficiency syndrome;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Trade Name: HyQvia 100 mg/ml solution for infusion for subcutaneous use
Product Name: HyQvia
INN or Proposed INN: Human normal immunoglobulin
Other descriptive name: HUMAN NORMAL IMMUNOGLOBULIN
Trade Name: KIOVIG 100 mg/ml solution for infusion
Product Name: KIOVIG
INN or Proposed INN: Human normal immunoglobulin
Other descriptive name: HUMAN NORMAL IMMUNOGLOBULIN (IV)
Trade Name: Cuvitru 200 mg/ml solution for subcutaneous injection
Product Name: Cuvitru
INN or Proposed INN: Human Normal Immunoglobulin
Other descriptive name: HUMAN NORMAL IMMUNOGLOBULIN
Baxalta US Inc.NULLNot RecruitingFemale: yes
Male: yes
40Phase 4France;Hungary;Czech Republic;Slovakia;Greece;Denmark;United Kingdom;Sweden
8EUCTR2016-003438-26-SE
(EUCTR)
04/04/201708/11/2016Study to further assess the positive effect of the immunoglobulin product for subcutaneous use, HyQvia, in children (age <18 years) with Primary Immunodeficiency Diseases who have received prior immunoglobulin therapy before enrollment into the study.Post-Authorization Safety, Tolerability and Immunogenicity Evaluation of HyQvia in Pediatric Subjects with Primary Immunodeficiency Diseases Primary Immunodeficiency Disease (PIDD)
MedDRA version: 20.0;Level: PT;Classification code 10064859;Term: Primary immunodeficiency syndrome;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Trade Name: HyQvia 100 mg/ml solution for infusion for subcutaneous use
Product Name: HyQvia
INN or Proposed INN: Human normal immunoglobulin
Other descriptive name: HUMAN NORMAL IMMUNOGLOBULIN
Trade Name: KIOVIG 100 mg/ml solution for infusion
Product Name: KIOVIG
INN or Proposed INN: Human normal immunoglobulin
Other descriptive name: HUMAN NORMAL IMMUNOGLOBULIN (IV)
Trade Name: Cuvitru 200 mg/ml solution for subcutaneous injection
Product Name: Cuvitru
INN or Proposed INN: Human Normal Immunoglobulin
Other descriptive name: HUMAN NORMAL IMMUNOGLOBULIN
Baxalta US Inc.NULLNot RecruitingFemale: yes
Male: yes
40Phase 4France;Hungary;Czech Republic;Slovakia;Greece;Denmark;United Kingdom;Sweden
9EUCTR2016-003438-26-GB
(EUCTR)
14/02/201701/11/2016Study to further assess the positive effect of the immunoglobulin product for subcutaneous use, HyQvia, in children (age <18 years) with Primary Immunodeficiency Diseases who have received prior immunoglobulin therapy before enrollment into the study.Post-Authorization Safety, Tolerability and Immunogenicity Evaluation of HyQvia in Pediatric Subjects with Primary Immunodeficiency Diseases Primary Immunodeficiency Disease (PIDD)
MedDRA version: 20.0;Level: PT;Classification code 10064859;Term: Primary immunodeficiency syndrome;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Trade Name: HyQvia 100 mg/ml solution for infusion for subcutaneous use
Product Name: HyQvia
INN or Proposed INN: Human normal immunoglobulin
Other descriptive name: HUMAN NORMAL IMMUNOGLOBULIN
Trade Name: KIOVIG 100 mg/ml solution for infusion
Product Name: KIOVIG
INN or Proposed INN: Human normal immunoglobulin
Other descriptive name: HUMAN NORMAL IMMUNOGLOBULIN (IV)
Trade Name: Cuvitru 200 mg/ml solution for subcutaneous injection
Product Name: Cuvitru
INN or Proposed INN: Human Normal Immunoglobulin
Other descriptive name: HUMAN NORMAL IMMUNOGLOBULIN
Baxalta US Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
40Phase 4France;Czech Republic;Slovakia;Greece;Denmark;United Kingdom;Sweden
10NCT03054181
(ClinicalTrials.gov)
December 22, 201613/2/2017Facilitated Immunoglobulin Administration Registry and Outcomes Study (FIGARO)Facilitated Immunoglobulin Administration Registry and Outcomes StudyPrimary Immunodeficiency;Secondary Immune DeficiencyBiological: HyQviaGWT-TUD GmbHNULLCompletedN/AN/AAll156France;Germany;Italy
11NCT02881437
(ClinicalTrials.gov)
November 11, 201617/8/2016IgG Level in Primary Immunodeficiency Switching From Standard SCIG to Every Other Week HyQviaAssessment of the IgG Trough Level in Subjects With Primary Immunodeficiency Switching From Standard Subcutaneous Immunoglobulin (SCIG) to Every Other Week HyQviaPrimary ImmunodeficiencyDrug: IgHy10University Hospital, LilleShireCompleted18 YearsN/AAll22Phase 4France
12EUCTR2016-001480-36-FR
(EUCTR)
11/07/201622/11/2016Assessment of the IgG trough level in subjects with primary immunodeficiency switching from standard subcutaneous immunoglobulin (SCIG) to every other week HyQviaAssessment of the IgG trough level in subjects with primary immunodeficiency switching from standard subcutaneous immunoglobulin (SCIG) to every other week HyQvia - HyQvia Primary immunodeficiencies
MedDRA version: 19.0;Level: PT;Classification code 10061598;Term: Immunodeficiency;System Organ Class: 10021428 - Immune system disorders ;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Trade Name: HyQvia
Other descriptive name: HyQvia
Centre Hospitalier Régional et Universitaire de LilleNULLNot Recruiting Female: yes
Male: yes
22 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noFrance
13NCT02593188
(ClinicalTrials.gov)
November 12, 201529/10/2015Non-Interventional Post-Marketing Safety Study on the Long-Term Safety of HYQVIA (Global)Non-Interventional Post-Marketing Safety Study on the Long-Term Safety of HYQVIA (Global)Primary Immunodeficiency Diseases (PID)Biological: HYQVIABaxalta now part of ShireNULLActive, not recruiting16 YearsN/AAll264United States
14EUCTR2016-003438-26-SK
(EUCTR)
01/02/2017Study to further assess the positive effect of the immunoglobulin product for subcutaneous use, HyQvia, in children (age <18 years) with Primary Immunodeficiency Diseases who have received prior immunoglobulin therapy before enrollment into the study.Post-Authorization Safety, Tolerability and Immunogenicity Evaluation of HyQvia in Pediatric Subjects with Primary Immunodeficiency Diseases Primary Immunodeficiency Disease (PIDD)
MedDRA version: 19.1;Level: PT;Classification code 10064859;Term: Primary immunodeficiency syndrome;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Trade Name: HyQvia 100 mg/ml solution for infusion for subcutaneous use
Product Name: HyQvia
INN or Proposed INN: Human normal immunoglobulin
Other descriptive name: HUMAN NORMAL IMMUNOGLOBULIN
Trade Name: KIOVIG 100 mg/ml solution for infusion
Product Name: KIOVIG
INN or Proposed INN: Human normal immunoglobulin
Other descriptive name: HUMAN NORMAL IMMUNOGLOBULIN (IV)
Trade Name: Cuvitru 200 mg/ml solution for subcutaneous injection
Product Name: Cuvitru
INN or Proposed INN: Human Normal Immunoglobulin
Other descriptive name: HUMAN NORMAL IMMUNOGLOBULIN
Baxalta US Inc.NULLNot RecruitingFemale: yes
Male: yes
40Phase 4France;Hungary;Czech Republic;Slovakia;Greece;Denmark;United Kingdom;Sweden