Kiovig    (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7
65原発性免疫不全症候群17

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:145,薬物数:139(DrugBank:23),標的遺伝子数:12,標的パスウェイ数:21
Searched query = "Chronic inflammatory demyelinating polyneuropathy", "Chronic inflammatory demyelinating poly (radiculo) neuropathy", "Multifocal motor neuropathy", "CIDP"
The queries were searched in Public_title, Scientific_title, and Condition. Export date: 03/15/2021. Trials are sorted by Date_enrollment from most recent to oldest in the table.
7 / 145 trials found
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1EUCTR2012-001995-12-IT19/05/201513/03/2013A European, randomised, double-blind, active comparator-controlled, cross-over, efficacy and safety study of a new 10% ready-to-use liquid human intravenous immunoglobulin (I10E) versus Kiovig® in patients with Multifocal Motor NeuropathyA European, randomised, double-blind, active comparator-controlled, cross-over, efficacy and safety study of a new 10% ready-to-use liquid human intravenous immunoglobulin (I10E) versus Kiovig® in patients with Multifocal Motor Neuropathy Multifocal motor neuropathy (MMN)
MedDRA version: 15.1Level: PTClassification code 10065579Term: Multifocal motor neuropathySystem Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: KIOVIG
Product Name: KIOVIG
INN or Proposed INN: HUMAN NORMAL IMMUNOGLOBULIN
Other descriptive name: HUMAN NORMAL IMMUNOGLOBULIN (IV)
Product Name: human normal immunoglobulin for intravenous administration
Product Code: I10E
INN or Proposed INN: HUMAN NORMAL IMMUNOGLOBULIN
Other descriptive name: HUMAN NORMAL IMMUNOGLOBULIN (IV)
LFB BIOTECHNOLOGIESNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
20Phase 3France;Spain;United Kingdom;Italy
2EUCTR2013-004988-32-NL22/01/201420/01/2014Pharmacokinetics of IVIg treatment in patients with CIDPRotterdam Observational Study in CIDP of Pharmacokinetics of Intravenous ?-globulin - ROCKY-1 Chronic Inflammatory Demyelinating Polyneuropathy;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]Trade Name: Kiovig
Product Name: Kiovig
Erasmus MCNULLNot RecruitingFemale: yes
Male: yes
Phase 4Netherlands
3NCT01951924December 201320/9/2013LIME Study (LFB IVIg MMN Efficacy Study)A European, Randomised, Double-blind, Active Comparator Controlled, Cross-over, Efficacy and Safety Study of a New 10% Ready To-use Liquid Human Intravenous Immunoglobulin (I10E) Versus Kiovig® in Patients With Multifocal Motor NeuropathyMotor Neuron DiseaseDrug: Biological : I10E (Human normal Immunoglobulin for intravenous administration 100mg/mL);Drug: Biological: Kiovig® (Human normal Immunoglobulin for intravenous administration 100mg/mL)Laboratoire français de Fractionnement et de BiotechnologiesTFS Trial Form SupportCompleted18 Years80 YearsBoth23Phase 3France;Italy;Spain;United Kingdom
4EUCTR2012-001995-12-GB01/08/201303/06/2013A European, randomised, double-blind, active comparator-controlled, cross-over, efficacy and safety study of a new 10% ready-to-use liquid human intravenous immunoglobulin (I10E) versus Kiovig® in patients with Multifocal Motor NeuropathyA European, randomised, double-blind, active comparator-controlled, cross-over, efficacy and safety study of a new 10% ready-to-use liquid human intravenous immunoglobulin (I10E) versus Kiovig® in patients with Multifocal Motor Neuropathy Multifocal motor neuropathy (MMN)
MedDRA version: 18.0 Level: PT Classification code 10065579 Term: Multifocal motor neuropathy System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
LFB BIOTECHNOLOGIESNULLNot Recruiting Female: yes
Male: yes
20 Human pharmacology (Phase 1): no Therapeut1c exploratory (Phase 2): no Therapeut1c conf1rmatory - (Phase 3): yes Therapeut1c use (Phase 4): noFrance;Spain;Italy;United Kingdom
5EUCTR2012-001995-12-ES12/07/201312/07/2013A European, randomised, double-blind, active comparator-controlled, cross-over, efficacy and safety study of a new 10% ready-to-use liquid human intravenous immunoglobulin (I10E) versus Kiovig® in patients with Multifocal Motor NeuropathyA European, randomised, double-blind, active comparator-controlled, cross-over, efficacy and safety study of a new 10% ready-to-use liquid human intravenous immunoglobulin (I10E) versus Kiovig® in patients with Multifocal Motor Neuropathy Multifocal motor neuropathy (MMN)
MedDRA version: 16.0Level: PTClassification code 10065579Term: Multifocal motor neuropathySystem Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: KIOVIG
Product Name: KIOVIG
INN or Proposed INN: HUMAN NORMAL IMMUNOGLOBULIN
Other descriptive name: HUMAN NORMAL IMMUNOGLOBULIN (IV)
Product Name: human normal immunoglobulin for intravenous administration
Product Code: I10E
INN or Proposed INN: HUMAN NORMAL IMMUNOGLOBULIN
Other descriptive name: HUMAN NORMAL IMMUNOGLOBULIN (IV)
LFB BIOTECHNOLOGIESNULLNot RecruitingFemale: yes
Male: yes
20Phase 3France;Spain;United Kingdom
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
6EUCTR2012-001995-12-FR03/07/201304/04/2014A European, randomised, double-blind, active comparator-controlled, cross-over, efficacy and safety study of a new 10% ready-to-use liquid human intravenous immunoglobulin (I10E) versus Kiovig® in patients with Multifocal Motor NeuropathyA European, randomised, double-blind, active comparator-controlled, cross-over, efficacy and safety study of a new 10% ready-to-use liquid human intravenous immunoglobulin (I10E) versus Kiovig® in patients with Multifocal Motor Neuropathy Multifocal motor neuropathy (MMN)
MedDRA version: 16.1Level: PTClassification code 10065579Term: Multifocal motor neuropathySystem Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: KIOVIG
Product Name: KIOVIG
INN or Proposed INN: HUMAN NORMAL IMMUNOGLOBULIN
Other descriptive name: HUMAN NORMAL IMMUNOGLOBULIN (IV)
Product Name: human normal immunoglobulin for intravenous administration
Product Code: I10E
INN or Proposed INN: HUMAN NORMAL IMMUNOGLOBULIN
Other descriptive name: HUMAN NORMAL IMMUNOGLOBULIN (IV)
LFB BIOTECHNOLOGIESNULLNot RecruitingFemale: yes
Male: yes
20Phase 3France;Spain;United Kingdom
7EUCTR2009-013841-27-DK17/12/200927/10/2009A Randomized, Double-Blind, Placebo Controlled, Cross-over Study of the Effectiveness of Immune Globulin Intravenous (Human), 10% (IGIV, 10%) for the Treatment of Multofocl Motor Neuropathy - IGIV, 10% MMN TrialA Randomized, Double-Blind, Placebo Controlled, Cross-over Study of the Effectiveness of Immune Globulin Intravenous (Human), 10% (IGIV, 10%) for the Treatment of Multofocl Motor Neuropathy - IGIV, 10% MMN Trial Multifocal motor neuropathy
MedDRA version: 12.0Level: LLTClassification code 10065579Term: Multifocal motor neuropathy
Trade Name: KIOVIG 100 mg/ml solution for infusion
Product Name: IGIV, 10%
Other descriptive name: HUMAN NORMAL IMMUNOGLOBULIN (IV)
Baxter Innovations GmbHNULLNot RecruitingFemale: yes
Male: yes
40Denmark

65. 原発性免疫不全症候群 [臨床試験数:413,薬物数:581(DrugBank:97),標的遺伝子数:68,標的パスウェイ数:202
Searched query = "Primary immunodeficiency", "X-SCID", "Reticular dysgenesis", "Adenosine deaminase deficiency", "Omenn syndrome", "Purine nucleoside phosphorylase deficiency", "CD8 deficiency", "ZAP-70 deficiency", "MHC class I deficiency", "MHC class II deficiency", "Combined immunodeficiency", "Wiskott-Aldrich syndrome", "Telangiectasia ataxia", "Nijmegen breakage syndrome", "Bloom syndrome", "Immunodeficiency, centromere region instability, facial anomalies syndrome", "ICF syndrome", "PMS2 deficiency", "Radiosensitivity, immunodeficiency, dysmorphic features, and learning difficulties syndrome", "RIDDLE syndrome", "Schimke syndrome", "Netherton syndrome", "Thymic hypoplasia", "DiGeorge syndrome", "22q11.2 deletion syndrome", "Hyper-IgE syndrome", "Hepatic venoocclusive immunodeficiency", "Immunodeficiency with central hepatic vein atresia", "Dyskeratosis congenita", "X-linked agammaglobulinaemia", "Common variable immunodeficiency", "Hyper-IgM syndrome", "Isolated IgG subclass deficiency", "Selective IgA deficiency", "Specific antibody production deficiency", "Infant transient hypogammaglobulinemia", "Chédiak-Higashi syndrome", "Chediak-Higashi syndrome", "X-linked lymphoproliferative syndrome", "SAP deficiency", "SH2D1A/SLAM-associated protein deficiency", "XIAP deficiency", "X-linked inhibitor of apoptosis deficiency", "Autoimmune lymphoproliferative syndrome", "ALPS", "Familial hemophagocytic syndrome", "Perforin deficiency", "Munc13-4 deficiency", "Syntaxin 11 deficiency", "Munc18-2 deficiency", "Autoimmune polyendocrinopathy-candidiasis-ectodermal dystrophy", "APECED", "Immune dysregulation, polyendocrinopathy, enteropathy, X-linked syndrome", "IPEX syndrome", "CD25 deficiency", "ITCH deficiency", "Primary phagocytic dysfunction", "Severe congenital neutropenia", "Cyclic neutropenia", "Hermanskyi-Pudlak syndrome type 2", "Hermanskyi-Pudlak syndrome 2", "Griscelli syndrome type 2", "Griscelli syndrome 2", "p14 deficiency", "Warts, hypogammaglobulinemia, infections, myelokathexis syndrome", "WHIM syndrome", "Glycogen storage disease type Ib", "Leukocyte adhesion deficiency", "Shwachman-Diamond syndrome", "Chronic granulomatous disease", "Myeloperoxidase deficiency", "Mendelian susceptibility to mycobacterial disease", "MSMD", "Anhidrotic ectodermal dysplasia with immunodeficiency", "EDA-ID", "Interleukin-1 receptor-associated kinase-4 deficiency", "IRAK4 deficiency", "IMyD88 deficiency", "Chronic mucocutaneous candidiasis", "Epidermodysplasia verruciformis", "Herpes simplex encephalitis", "Caspase recruitment domain family member 9 deficiency", "CARD9 deficiency", "Trypanosomiasis", "Congenital complement deficiency", "C1q deficiency", "CC1r deficiency", "CC1s deficiency", "CC2 deficiency", "CC3 deficiency", "CC4 deficiency", "CC5 deficiency", "CC6 deficiency", "CC7 deficiency", "CC8 deficiency", "CC9 deficiency", "Factor D deficiency", "Properdin deficiency", "Factor I deficiency", "Factor H deficiency", "MASP1 deficiency", "3MC syndrome", "Mannose-binding protein-associated serine protease 2 deficiency", "MASP2 deficiency", "FCN3", "Hereditary angioedema type 1", "Hereditary angioedema type I", "C1 inhibitor deficiency type 1", "C1 inhibitor deficiency type I", "Hereditary angioedema type 2", "Hereditary angioedema type II", "C1 inhibitor deficiency type 2", "C1 inhibitor deficiency type II", "Hereditary angioedema type 3", "Hereditary angioedema type III", "C1 inhibitor deficiency type 3", "C1 inhibitor deficiency type III"
The queries were searched in Public_title, Scientific_title, and Condition. Export date: 03/15/2021. Trials are sorted by Date_enrollment from most recent to oldest in the table.
17 / 413 trials found
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-GR13/11/201711/10/2017Study 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: 20.0Level: PTClassification code 10064859Term: Primary immunodeficiency syndromeSystem 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
2NCT03116347June 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 ShireActive, not recruiting2 Years17 YearsAll42Phase 4Czechia;Denmark;France;Greece;Slovakia;Sweden;United Kingdom
3EUCTR2016-003438-26-CZ18/05/201727/01/2017Study 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: 20.0Level: PTClassification code 10064859Term: Primary immunodeficiency syndromeSystem 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;Hungary;Czech Republic;Slovakia;Greece;Denmark;United Kingdom;Sweden
4EUCTR2016-003438-26-DK08/05/201719/01/2017Study 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: 20.0Level: PTClassification code 10064859Term: Primary immunodeficiency syndromeSystem 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;Hungary;Czech Republic;Slovakia;Greece;Denmark;United Kingdom;Sweden
5EUCTR2016-003438-26-FR18/04/201721/03/2017Study 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: 19.1Level: PTClassification code 10064859Term: Primary immunodeficiency syndromeSystem 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;United Kingdom;Sweden
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
6EUCTR2016-003438-26-SE04/04/201708/11/2016Study 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: 20.0Level: PTClassification code 10064859Term: Primary immunodeficiency syndromeSystem 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;Hungary;Czech Republic;Slovakia;Greece;Denmark;United Kingdom;Sweden
7EUCTR2016-003438-26-GB14/02/201701/11/2016Study 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: 20.0Level: PTClassification code 10064859Term: Primary immunodeficiency syndromeSystem 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
8EUCTR2012-000481-38-GB28/06/201226/04/2012Assessment of the safety of Immunoglobulin and recombinant human hylaluronidase in the treatment of patients with primary immunodeficiencyTolerability, Safety and Product Administration Evaluation of rHuPH20 Facilitated Subcutaneous Treatment with Immune Globulin (Human), 10% in Subjects with Primary Immunodeficiency Diseases – A Study in Europe - Tolerability and Safety of IG, 10% with rHuPH20 in PIDD Primary Immunodeficiency Diseases
MedDRA version: 14.1Level: HLTClassification code 10036700Term: Primary immunodeficiency syndromesSystem Organ Class: 10021428 - Immune system disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Trade Name: KIOVIG 100 mg/ml solution for infusion
Product Name: Human normal immunoglobulin
INN or Proposed INN: HUMAN NORMAL IMMUNOGLOBULIN
Other descriptive name: HUMAN NORMAL IMMUNOGLOBULIN
Trade Name: KIOVIG 100 mg/ml solution for infusion
Product Name: Human normal immunoglobulin
INN or Proposed INN: HUMAN NORMAL IMMUNOGLOBULIN
Other descriptive name: HUMAN NORMAL IMMUNOGLOBULIN
Product Name: Recombinant Human Hyaluronidase (rHuPH20)
INN or Proposed INN: HYALURONIDASE
Other descriptive name: 36-482-Hyaluronoglucosaminidase PH20 (rHuPH20)
Trade Name: KIOVIG 100 mg/ml solution for infusion
Product Name: Human normal immunoglobulin
INN or Proposed INN: HUMAN NORMAL IMMUNOGLOBULIN
Other descriptive name: HUMAN NORMAL IMMUNOGLOBULIN
Trade Name: KIOVIG 100 mg/ml solution for infusion
Product Name: Human normal immunoglobulin
INN or Proposed INN: HUMAN NORMAL IMMUNOGLOBULIN
Other descriptive name: HUMAN NORMAL IMMUNOGLOBULIN
Product Name: Recombinant Human Hyaluronidase (rHuPH20)
INN or Proposed INN: HYALURONIDASE
Other descriptive name: 36-482-Hyaluronoglucosaminidase PH20 (rHuPH20)
Baxter Innovations GmbHNULLNot RecruitingFemale: yes
Male: yes
40Czech Republic;Belgium;Netherlands;Germany;Switzerland;Italy;United Kingdom;Sweden
9EUCTR2010-019459-23-BE29/03/201214/02/2012CLINICAL STUDY OF THE EFFECTIVENESS AND SAFETY OF SUBCUTANEOUS IMMUNE GLOBULIN, 20% IN PATIENTS WITH PRIMARY IMMUNODEFICIENCY DISEASESA CLINICAL STUDY OF IMMUNE GLOBULIN SUBCUTANEOUS (HUMAN) (IGSC), 20% FOR THE EVALUATION OF EFFICACY, SAFETY, AND PHARMACOKINETICS IN SUBJECTS WITH PRIMARY IMMUNODEFICIENCY DISEASES - EU Study of IGSC, 20% in PID Primary Immunodeficiency Diseases
MedDRA version: 16.0Level: PTClassification code 10064859Term: Primary immunodeficiency syndromeSystem Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Trade Name: KIOVIG
Product Name: KIOVIG
Product Code: IGIV, 10%
INN or Proposed INN: Human normal immunoglobulin
Other descriptive name: HUMAN NORMAL IMMUNOGLOBULIN (IV)
Trade Name: SUBCUVIA
Product Name: SUBCUVIA
Product Code: IGSC, 16%
INN or Proposed INN: Human normal immunoglobulin
Other descriptive name: HUMAN NORMAL IMMUNOGLOBULIN
Product Name: Immune Globulin Subcutaneous, 20%
Product Code: IGSC, 20%
INN or Proposed INN: Human normal immunoglobulin
Other descriptive name: HUMAN NORMAL IMMUNOGLOBULIN
Baxter Innovations GmbHNULLNot RecruitingFemale: yes
Male: yes
47Phase 2;Phase 3Hungary;Belgium;Austria;Netherlands;Germany;United Kingdom;Sweden
10EUCTR2010-019459-23-NL24/08/201127/01/2011CLINICAL STUDY OF THE EFFICACY AND SAFETY OF SUBCUTANEOUSIMMUNE GLOBULIN, 20% IN PATIENTS WITH PRIMARYIMMUNODEFICIENCY DISEASESA CLINICAL STUDY OF IMMUNE GLOBULIN SUBCUTANEOUS (HUMAN) (IGSC), 20% FOR THE EVALUATION OF EFFICACY, SAFETY, AND PHARMACOKINETICS IN SUBJECTS WITH PRIMARY IMMUNODEFICIENCY DISEASES - EU Study of IGSC, 20% in PID Primary Immunodeficiency Diseases
MedDRA version: 16.0Level: PTClassification code 10064859Term: Primary immunodeficiency syndromeSystem Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Trade Name: KIOVIG
Product Name: KIOVIG
Product Code: IGIV, 10%
INN or Proposed INN: Human normal immunoglobulin
Other descriptive name: HUMAN NORMAL IMMUNOGLOBULIN (IV)
Trade Name: SUBCUVIA
Product Name: SUBCUVIA
Product Code: IGSC, 16%
INN or Proposed INN: Human normal immunoglobulin
Other descriptive name: HUMAN NORMAL IMMUNOGLOBULIN
Product Name: Immune Globulin Subcutaneous, 20%
Product Code: IGSC, 20%
INN or Proposed INN: Human normal immunoglobulin
Other descriptive name: HUMAN NORMAL IMMUNOGLOBULIN
Baxter Innovations GmbHNULLNot RecruitingFemale: yes
Male: yes
47Phase 2;Phase 3Hungary;Belgium;Austria;Germany;Netherlands;United Kingdom;Sweden
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
11EUCTR2010-019459-23-SE23/03/201125/01/2011CLINICAL STUDY OF THE EFFECTIVENESS AND SAFETY OF SUBCUTANEOUS IMMUNE GLOBULIN, 20% IN PATIENTS WITH PRIMARY IMMUNODEFICIENCY DISEASESA CLINICAL STUDY OF IMMUNE GLOBULIN SUBCUTANEOUS (HUMAN) (IGSC), 20% FOR THE EVALUATION OF EFFICACY, SAFETY, AND PHARMACOKINETICS IN SUBJECTS WITH PRIMARY IMMUNODEFICIENCY DISEASES - EU Study of IGSC, 20% in PID Primary Immunodeficiency Diseases
MedDRA version: 16.0Level: PTClassification code 10064859Term: Primary immunodeficiency syndromeSystem Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Trade Name: KIOVIG
Product Name: KIOVIG
Product Code: IGIV, 10%
INN or Proposed INN: Human normal immunoglobulin
Other descriptive name: HUMAN NORMAL IMMUNOGLOBULIN (IV)
Trade Name: SUBCUVIA
Product Name: SUBCUVIA
Product Code: IGSC, 16%
INN or Proposed INN: Human normal immunoglobulin
Other descriptive name: HUMAN NORMAL IMMUNOGLOBULIN
Product Name: Immune Globulin Subcutaneous, 20%
Product Code: IGSC, 20%
INN or Proposed INN: Human normal immunoglobulin
Other descriptive name: HUMAN NORMAL IMMUNOGLOBULIN
Baxter Innovations GmbHNULLNot RecruitingFemale: yes
Male: yes
47Hungary;Belgium;Austria;Netherlands;Germany;United Kingdom;Sweden
12EUCTR2010-019459-23-DE18/01/201128/07/2010CLINICAL STUDY OF THE EFFICACY AND SAFETY OF SUBCUTANEOUS IMMUNE GLOBULIN, 20% IN PATIENTS WITH PRIMARY IMMUNODEFICIENCY DISEASESA CLINICAL STUDY OF IMMUNE GLOBULIN SUBCUTANEOUS (HUMAN) (IGSC), 20% FOR THE EVALUATION OF EFFICACY, SAFETY, AND PHARMACOKINETICS IN SUBJECTS WITH PRIMARY IMMUNODEFICIENCY DISEASES - EU Study of IGSC, 20% in PID Primary Immunodeficiency Diseases
MedDRA version: 16.1Level: PTClassification code 10064859Term: Primary immunodeficiency syndromeSystem Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Trade Name: KIOVIG
Product Name: KIOVIG
Product Code: IGIV, 10%
INN or Proposed INN: Human normal immunoglobulin
Other descriptive name: HUMAN NORMAL IMMUNOGLOBULIN (IV)
Trade Name: SUBCUVIA
Product Name: SUBCUVIA
Product Code: IGSC, 16%
INN or Proposed INN: Human normal immunoglobulin
Other descriptive name: HUMAN NORMAL IMMUNOGLOBULIN
Product Name: Immune Globulin Subcutaneos, 20%
Product Code: IGSC, 20%
INN or Proposed INN: Human normal immunoglobulin
Other descriptive name: HUMAN NORMAL IMMUNOGLOBULIN
Baxter Innovations GmbHNULLNot RecruitingFemale: yes
Male: yes
47Hungary;Belgium;Austria;Netherlands;Germany;United Kingdom;Sweden
13EUCTR2010-019459-23-GB21/12/201005/10/2010CLINICAL STUDY OF THE EFFICACY AND SAFETY OF SUBCUTANEOUSIMMUNE GLOBULIN, 20% IN PATIENTS WITH PRIMARYIMMUNODEFICIENCY DISEASESA CLINICAL STUDY OF IMMUNE GLOBULIN SUBCUTANEOUS (HUMAN) (IGSC), 20% FOR THE EVALUATION OF EFFICACY, SAFETY, AND PHARMACOKINETICS IN SUBJECTS WITH PRIMARY IMMUNODEFICIENCY DISEASES - EU Study of IGSC, 20% in PID Primary Immunodeficiency Diseases
MedDRA version: 14.1Level: PTClassification code 10064859Term: Primary immunodeficiency syndromeSystem Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Trade Name: KIOVIG
Product Name: KIOVIG
Product Code: IGIV, 10%
INN or Proposed INN: Human normal immunoglobulin
Other descriptive name: HUMAN NORMAL IMMUNOGLOBULIN (IV)
Trade Name: SUBCUVIA
Product Name: SUBCUVIA
Product Code: IGSC, 16%
INN or Proposed INN: Human normal immunoglobulin
Other descriptive name: HUMAN NORMAL IMMUNOGLOBULIN
Product Name: Immune Globulin Subcutaneous, 20%
Product Code: IGSC, 20%
INN or Proposed INN: Human normal immunoglobulin
Other descriptive name: HUMAN NORMAL IMMUNOGLOBULIN
Baxter Innovations GmbHNULLNot RecruitingFemale: yes
Male: yes
47Hungary;Belgium;Austria;Netherlands;Germany;United Kingdom;Sweden
14EUCTR2010-019459-23-HU20/12/201020/10/2010CLINICAL STUDY OF THE EFFICACY AND SAFETY OF SUBCUTANEOUSIMMUNE GLOBULIN, 20% IN PATIENTS WITH PRIMARYIMMUNODEFICIENCY DISEASESA CLINICAL STUDY OF IMMUNE GLOBULIN SUBCUTANEOUS (HUMAN) (IGSC), 20% FOR THE EVALUATION OF EFFICACY, SAFETY, AND PHARMACOKINETICS IN SUBJECTS WITH PRIMARY IMMUNODEFICIENCY DISEASES - EU Study of IGSC, 20% in PID Primary Immunodeficiency Diseases
MedDRA version: 16.0Level: PTClassification code 10064859Term: Primary immunodeficiency syndromeSystem Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Trade Name: KIOVIG
Product Name: KIOVIG
Product Code: IGIV, 10%
INN or Proposed INN: Human normal immunoglobulin
Other descriptive name: HUMAN NORMAL IMMUNOGLOBULIN (IV)
Trade Name: SUBCUVIA
Product Name: SUBCUVIA
Product Code: IGSC, 16%
INN or Proposed INN: Human normal immunoglobulin
Other descriptive name: HUMAN NORMAL IMMUNOGLOBULIN
Product Name: Immune Globulin Subcutaneous, 20%
Product Code: IGSC, 20%
INN or Proposed INN: Human normal immunoglobulin
Other descriptive name: HUMAN NORMAL IMMUNOGLOBULIN
Baxter Innovations GmbHNULLNot RecruitingFemale: yes
Male: yes
47Hungary;Belgium;Austria;Netherlands;Germany;United Kingdom;Sweden
15EUCTR2010-019459-23-AT05/11/201002/08/2010CLINICAL STUDY OF THE EFFICACY AND SAFETY OF SUBCUTANEOUS IMMUNE GLOBULIN, 20% IN PATIENTS WITH PRIMARY IMMUNODEFICIENCY DISEASESA CLINICAL STUDY OF IMMUNE GLOBULIN SUBCUTANEOUS (HUMAN) (IGSC), 20% FOR THE EVALUATION OF EFFICACY, SAFETY, AND PHARMACOKINETICS IN SUBJECTS WITH PRIMARY IMMUNODEFICIENCY DISEASES - EU Study of IGSC, 20% in PID Primary Immunodeficiency Diseases
MedDRA version: 14.1Level: PTClassification code 10064859Term: Primary immunodeficiency syndromeSystem Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Trade Name: KIOVIG
Product Name: KIOVIG
Product Code: IGIV, 10%
INN or Proposed INN: Human normal immunoglobulin
Other descriptive name: HUMAN NORMAL IMMUNOGLOBULIN (IV)
Trade Name: SUBCUVIA
Product Name: SUBCUVIA
Product Code: IGSC, 16%
INN or Proposed INN: Human normal immunoglobulin
Other descriptive name: HUMAN NORMAL IMMUNOGLOBULIN
Product Name: Immune Globulin Subcutaneous, 20%
Product Code: IGSC, 20%
INN or Proposed INN: Human normal immunoglobulin
Other descriptive name: HUMAN NORMAL IMMUNOGLOBULIN
Baxter Innovations GmbHNULLNot RecruitingFemale: yes
Male: yes
47Hungary;Belgium;Austria;Netherlands;Germany;United Kingdom;Sweden
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
16NCT00814320December 18, 200823/12/2008Gammagard Liquid and rHuPH20 in PIDEfficacy, Tolerability and Pharmacokinetic Comparison of Immune Globulin Intravenous (Human), 10% (GAMMAGARD LIQUID/KIOVIG) Administered Intravenously or Subcutaneously Following Administration of Recombinant Human Hyaluronidase (rHuPH20) in Subjects With Primary Immunodeficiency DiseasesPrimary Immunodeficiency Diseases (PID)Biological: Recombinant human hyaluronidase (rHuPH20)+ immune globulin intravenous (IGIV)Baxalta now part of ShireNULLCompleted2 YearsN/AAll89Phase 3United States;Canada
17EUCTR2016-003438-26-SK01/02/2017Study 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: 19.1Level: PTClassification code 10064859Term: Primary immunodeficiency syndromeSystem 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.NULLNAFemale: yes
Male: yes
40Phase 4France;Czech Republic;Slovakia;Denmark;United Kingdom;Sweden