65. 原発性免疫不全症候群 Primary immunodeficiency Clinical trials / Disease details


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

  
108 trials found
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1NCT05070455
(ClinicalTrials.gov)
March 1, 202223/9/2021An Open Label, Multicenter Study to Evaluate the Pharmacokinetics, Efficacy and Safety of ASCENIV™ (IGIV) in Pediatric Subjects With Primary Immunodeficiency Diseases (PIDD)An Open Label, Multicenter Study to Evaluate the Pharmacokinetics, Efficacy and Safety of ASCENIV™ (IGIV) in Pediatric Subjects With Primary Immunodeficiency Diseases (PIDD)Primary Immune DeficiencyBiological: Asceniv™ADMA Biologics, Inc.NULLNot yet recruiting2 Years11 YearsAll12Phase 4NULL
2JPRN-jRCT2031210457
24/01/202227/11/2021A Study of TAK-771 in Japanese People With Primary Immunodeficiency Diseases (PID)A Phase 3, Open-label, Non-controlled Study to Evaluate the Pharmacokinetics, Safety and Tolerability, and Efficacy of TAK-771 in Japanese Subjects with Primary Immunodeficiency Diseases (PID) Primary Immunodeficiency Diseases (PID)Epoch 1: TAK-771 Ramp up Period
TAK-771 includes Immune Globulin Infusion (IGI) 10% and Recombinant Human Hyaluronidase (rHuPH20). Participants will receive SC infusion of rHuPH20 solution at a dose of 80 U/g IgG first, followed by SC infusion of 10% IGI within 10 minutes of completion of the infusion of rHuPH20 solution. The dose of 10% IGI will be increased from 1/3 of full dose to full dose in 3 weeks for participants who will receive TAK-771 once every 3 week, or from 1/4 of full dose to full dose in 6 weeks for participants who will receive TAK-771 once every 4 week.

Epoch 2: TAK-771 Treatment Period
TAK-771 includes Immune Globulin Infusion (IGI) 10% and Recombinant Human Hyaluronidase (rHuPH20). Participants will receive subcutaneous infusion of rHuPH20 solution at a dose of 80 U/g IgG first, followed by SC infusion of 10% IGI within 10 minutes of completion of the infusion of rHuPH20 solution, every 3, or 4 weeks for up to Week 24.
Nishizawa AtsushiNULLRecruiting>= 2age oldNot applicableBoth15Phase 3Japan
3NCT05150340
(ClinicalTrials.gov)
January 24, 202224/11/2021A Study of TAK-771 in Japanese People With Primary Immunodeficiency Diseases (PID)A Phase 3, Open-label, Non-controlled Study to Evaluate the Pharmacokinetics, Safety and Tolerability, and Efficacy of TAK-771 in Japanese Subjects With Primary Immunodeficiency Diseases (PID)Primary Immunodeficiency Diseases (PID)Drug: TAK-771TakedaNULLRecruiting2 YearsN/AAll15Phase 3Japan
4NCT04554914
(ClinicalTrials.gov)
July 14, 202114/9/2020A Study to Evaluate Tabelecleucel in Participants With Epstein-barr Virus-associated DiseasesAn Open-label, Single-arm, Multicohort, Phase 2 Study to Assess the Efficacy and Safety of Tabelecleucel in Subjects With Epstein-Barr Virus-associated DiseasesEpstein-Barr Virus (EBV)-Associated Diseases;EBV+ Lymphoproliferative Disease With Primary Immunodeficiency (PID LPD);EBV+ Lymphoproliferative Disease With Acquired (Non-congenital) Immunodeficiency (AID LPD);EBV+ Posttransplant Lymphoproliferative Disease in Central Nervous System (CNS PTLD);EBV+ Post-transplant Lymphoproliferative Disease (EBV+ PTLD);Solid Organ Transplant Complications;Lymphoproliferative Disorders;Allogeneic Hematopoietic Cell Transplant;Stem Cell Transplant Complications;EBV+ Sarcomas;Leiomyosarcoma;Chronic Active Epstein-Barr Virus (CAEBV);Chronic Active Epstein-Barr Virus With Hemophagocytic Lymphohistiocytosis (HLH);Lymphohistiocytosis, HemophagocyticBiological: TabelecleucelAtara BiotherapeuticsNULLRecruitingN/AN/AAll228Phase 2United States;Austria;Belgium;France;Italy;Spain;United Kingdom
5EUCTR2020-001496-32-PT
(EUCTR)
11/05/202111/08/2020Study, in which all know the treatment assigned to the patient, conducted in more sites, to evaluate the efficaty, safety, and metabolism of Kedrion in venous Human Normal Immunoglobulin (IVIg) 10% in child with Primary Immunodeficiency Disease (PID)A Phase III, Open-label, Prospective, Multicenter Study to Assess Efficacy, Safety, and Pharmacokinetics of Kedrion Intravenous Human Normal Immunoglobulin (IVIg) 10% in Pediatric Patients Affected by Primary Immunodeficiency Disease (PID) - PID-PED study Pediatric Patients Affected by Primary Immunodeficiency Disease.
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]
Product Name: KIg10
Product Code: KIg10
INN or Proposed INN: Human Immunoglobulin
KEDRION S.P.ANULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
30Phase 3Portugal;Hungary;Slovakia;Russian Federation;Italy
6NCT04842643
(ClinicalTrials.gov)
April 27, 202111/4/2021A Phase 3, Open-label, Non-controlled, Multi-dose, Extension Study to Evaluate the Long-term Safety and Tolerability of IGSC, 20% in Japanese Subjects With Primary Immunodeficiency Disease (PID)A Phase 3, Open-label, Non-controlled, Multi-dose, Extension Study to Evaluate the Long-term Safety and Tolerability of IGSC, 20% in Japanese Subjects With Primary Immunodeficiency Disease (PID)Primary Immunodeficiency DiseaseBiological: IGSC 20% infusionTakedaNULLRecruiting2 YearsN/AAll10Phase 3Japan
7NCT04944979
(ClinicalTrials.gov)
March 31, 202111/6/2021Clinical Assessment of Pharmacokinetics, Efficacy, and Safety of 10% IVIg in Pediatric PID Patients (KIDCARES10)A Phase III, Open-label, Prospective, Multicenter Study to Assess Efficacy, Safety, and Pharmacokinetics of Kedrion Intravenous Human Normal Immunoglobulin (IVIg) 10% in Pediatric Patients Affected by Primary Immunodeficiency Disease (PID)Primary Immunodeficiency DiseaseBiological: Kedrion IVIG 10%Kedrion S.p.A.NULLRecruiting2 Years16 YearsAll30Phase 3Hungary;Italy;Slovakia
8EUCTR2020-001496-32-IT
(EUCTR)
21/12/202021/10/2020Study, in which all know the treatment assigned to the patient, conducted in more sites, to evaluate the efficaty, safety, and metabolism of Kedrion in venous Human Normal Immunoglobulin (IVIg) 10% in child with Primary Immunodeficiency Disease (PID)A Phase III, Open-label, Prospective, Multicenter Study to Assess Efficacy, Safety, and Pharmacokinetics of Kedrion Intravenous Human Normal Immunoglobulin (IVIg) 10% in Pediatric Patients Affected by Primary Immunodeficiency Disease (PID) - PID-PED study Pediatric Patients Affected by Primary Immunodeficiency Disease
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]
Product Name: KIg10
Product Code: [KIg10]
INN or Proposed INN: IMMUNOGLOBULINA UMANA NORMALE
KEDRION S.P.ANULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
30Phase 3Portugal;Hungary;Slovakia;Italy
9NCT04691622
(ClinicalTrials.gov)
October 26, 202028/12/2020Adoptive T Lymphocyte Administration for Chronic Norovirus Treatment in Immunocompromised HostsAdoptive T Lymphocyte Administration for Chronic Norovirus Treatment in Immunocompromised HostsViral Infection;Hematopoietic Stem Cell Transplantation (HSCT);Primary Immunodeficiency Disorders (PID)Biological: Norovirus -specific T-cell (NST) therapyChildren's National Research InstituteNULLRecruiting3 Months80 YearsAll48Phase 1United States
10EUCTR2020-001496-32-SK
(EUCTR)
01/10/202002/07/2020Study, in which all know the treatment assigned to the patient, conducted in more sites, to evaluate the efficaty, safety, and metabolism of Kedrion in venous Human Normal Immunoglobulin (IVIg) 10% in child with Primary Immunodeficiency Disease (PID)A Phase III, Open-label, Prospective, Multicenter Study to Assess Efficacy, Safety, and Pharmacokinetics of Kedrion Intravenous Human Normal Immunoglobulin (IVIg) 10% in Pediatric Patients Affected by Primary Immunodeficiency Disease (PID) - PID-PED study Pediatric Patients Affected by Primary Immunodeficiency Disease.
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]
Product Name: KIg10
Product Code: KIg10
INN or Proposed INN: Human Immunoglobulin
KEDRION S.P.ANULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
30Phase 3Portugal;Hungary;Slovakia;Russian Federation;Italy
11EUCTR2020-001496-32-HU
(EUCTR)
09/09/202002/07/2020Study, in which all know the treatment assigned to the patient, conducted in more sites, to evaluate the efficaty, safety, and metabolism of Kedrion in venous Human Normal Immunoglobulin (IVIg) 10% in child with Primary Immunodeficiency Disease (PID)A Phase III, Open-label, Prospective, Multicenter Study to Assess Efficacy, Safety, and Pharmacokinetics of Kedrion Intravenous Human Normal Immunoglobulin (IVIg) 10% in Pediatric Patients Affected by Primary Immunodeficiency Disease (PID) - PID-PED study Pediatric Patients Affected by Primary Immunodeficiency Disease.
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]
Product Name: KIg10
Product Code: KIg10
INN or Proposed INN: Human Immunoglobulin
KEDRION S.P.ANULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
30Phase 3Portugal;Hungary;Slovakia;Russian Federation;Italy
12NCT04528355
(ClinicalTrials.gov)
August 20, 202018/8/2020Data Collection Study of Patients With Non-Malignant Disorders Undergoing UCBT, BMT or PBSCT With RICA Prospective Outcomes Study of Pediatric and Adult Patients With Non-Malignant Disorders Undergoing Umbilical Cord Blood, Bone Marrow, or Peripheral Blood Stem Cell Transplantation With a Reduced-Intensity Conditioning Regimen (PRO-RIC)Primary Immunodeficiency (PID);Congenital Bone Marrow Failure Syndromes;Inherited Metabolic Disorders (IMD);Hereditary Anemias;Inflammatory ConditionsDrug: data collectionPaul SzabolcsNULLRecruiting2 Months60 YearsAll50United States
13NCT04346108
(ClinicalTrials.gov)
August 11, 202010/4/2020A Study of Immune Globulin Subcutaneous (Human), 20% Solution (IGSC, 20%) in Japanese Participants With Primary Immunodeficiency Diseases (PID)A Phase 3, Open-label, Non-controlled, Multi-dose Study to Evaluate the Pharmacokinetics, Safety and Tolerability, and Efficacy of Immune Globulin Subcutaneous (Human), 20% Solution (IGSC, 20%) in Japanese Subjects With Primary Immunodeficiency Diseases (PID)Primary Immunodeficiency Diseases (PID)Biological: Immune Globulin Intravenous (IGIV);Biological: Immune Globulin Subcutaneous, 20% Solution (IGSC, 20%)Baxalta now part of ShireNULLCompleted2 YearsN/AAll17Phase 3Japan
14EUCTR2016-003438-26-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
15NCT03961009
(ClinicalTrials.gov)
April 30, 201921/5/2019Clinical Assessment of Pharmacokinetics, Efficacy, and Safety of 10% IVIg in PID PatientsA Phase III, Open-label, Prospective, Multicenter Study to Assess Efficacy, Safety and Pharmacokinetics of Kedrion Intravenous Immunoglobulin (IVIg) 10% in Primary Immunodeficiency Disease (PID) PatientsPrimary Immunodeficiency DiseaseBiological: Kedrion IVIG 10%Kedrion S.p.A.NULLCompleted2 Years70 YearsAll47Phase 3United States;Canada
16NCT03619551
(ClinicalTrials.gov)
October 22, 201816/7/2018Conditioning SCID Infants Diagnosed EarlyA Randomized Trial of Low Versus Moderate Exposure Busulfan for Infants With Severe Combined Immunodeficiency (SCID) Receiving TCRaß+/CD19+ Depleted Transplantation: A Phase II Study by the Primary Immune Deficiency Treatment Consortium (PIDTC) and Pediatric Blood and Marrow Transplant Consortium (PBMTC)SCIDDrug: Busulfan;Device: Cell processing for TCRaß+/CD19+ depletionMichael Pulsipher, MDNULLRecruitingN/A2 YearsAll64Phase 2United States
17NCT03716700
(ClinicalTrials.gov)
September 24, 201831/8/2018Real-world CANadian CUvitru Non-Interventional Study in Subjects Transitioning From Subcutaneous Immunoglobulin (CANCUN)Real-world CANadian CUvitru Non-Interventional Study in Subjects Transitioning From Subcutaneous Immunoglobulin (CANCUN)Primary Immunodeficiency Diseases (PID)Biological: CUVITRUBaxalta now part of ShireBaxalta Innovations GmbH, now part of ShireCompleted3 YearsN/AAll126Canada
18EUCTR2016-003438-26-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
19NCT03277313
(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
20NCT03116347
(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
21EUCTR2016-003438-26-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
22EUCTR2016-003438-26-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
23EUCTR2016-003438-26-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
24EUCTR2016-003438-26-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
25EUCTR2016-003438-26-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
26EUCTR2015-003652-52-GB
(EUCTR)
02/02/201708/08/2016An open label, prospective, multicenter study investigating clinical efficacy, safety, and pharmacokinetic properties of the human normal immunoglobulin for intravenous administration BT595 as replacement therapy in patients with primary immunodeficiency disease (PID)An open label, prospective, multicenter study investigating clinical efficacy, safety, and pharmacokinetic properties of the human normal immunoglobulin for intravenous administration BT595 as replacement therapy in patients with primary immunodeficiency disease (PID) Replacement therapy in patients with primary immunodeficiency disease (PID)
MedDRA version: 19.0;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]
Product Name: IgG Next Generation
Product Code: BT595
INN or Proposed INN: HUMAN NORMAL IMMUNOGLOBULIN (IV)
Other descriptive name: HUMAN NORMAL IMMUNOGLOBULIN (IV)
Biotest AGNULLNot RecruitingFemale: yes
Male: yes
60Phase 3United States;Spain;Russian Federation;Germany;United Kingdom
27NCT03033745
(ClinicalTrials.gov)
February 1, 201723/1/2017Safety and Tolerability of Higher Infusion Parameters of IgPro20 (Hizentra) in Subjects With Primary Immunodeficiency (PID)An Open-label Multicenter Study to Evaluate the Safety and Tolerability of Higher Infusion Parameters of Immune Globulin Subcutaneous (Human), 20% Liquid (Hizentra®) in Subjects With Primary ImmunodeficiencyPrimary ImmunodeficiencyDrug: IgPro20CSL BehringNULLCompleted2 YearsN/AAll49Phase 4United States;Canada
28NCT02810444
(ClinicalTrials.gov)
October 4, 201615/6/2016Study to Investigate Efficacy, Safety and Pharmacokinetics of BT595 in Subjects With PIDAn Open-label, Prospective, Multicenter Study Investigating Clinical Efficacy, Safety, and Pharmacokinetic Properties of the Human Normal Immunoglobulin for Intravenous Administration BT595 as Replacement Therapy in Patients With Primary Immunodeficiency Disease (PID)Primary Immunodeficiency DiseaseBiological: IgG Next Generation (BT595)BiotestSyneos HealthCompleted2 Years75 YearsAll81Phase 3United States;Germany;Hungary;Russian Federation;Spain
29EUCTR2015-003652-52-DE
(EUCTR)
29/09/201618/05/2016An open label, prospective, multicenter study investigating clinical efficacy, safety, and pharmacokinetic properties of the human normal immunoglobulin for intravenous administration BT595 as replacement therapy in patients with primary immunodeficiency disease (PID)An open label, prospective, multicenter study investigating clinical efficacy, safety, and pharmacokinetic properties of the human normal immunoglobulin for intravenous administration BT595 as replacement therapy in patients with primary immunodeficiency disease (PID) Replacement therapy in patients with primary immunodeficiency disease (PID)
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]
Product Name: IgG Next Generation
Product Code: BT595
INN or Proposed INN: HUMAN NORMAL IMMUNOGLOBULIN (IV)
Other descriptive name: HUMAN NORMAL IMMUNOGLOBULIN (IV)
Biotest AGNULLNot RecruitingFemale: yes
Male: yes
70Phase 3United States;Spain;Russian Federation;Germany;United Kingdom
30EUCTR2015-003652-52-ES
(EUCTR)
19/09/201615/07/2016An open label, prospective, multicenter study investigating clinical efficacy, safety, and pharmacokinetic properties of the human normal immunoglobulin for intravenous administration BT595 as replacement therapy in patients with primary immunodeficiency disease (PID)An open label, prospective, multicenter study investigating clinical efficacy, safety, and pharmacokinetic properties of the human normal immunoglobulin for intravenous administration BT595 as replacement therapy in patients with primary immunodeficiency disease (PID) Replacement therapy in patients with primary immunodeficiency disease (PID)
MedDRA version: 19.0;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]
Product Name: IgG Next Generation
Product Code: BT595
INN or Proposed INN: HUMAN NORMAL IMMUNOGLOBULIN (IV)
Other descriptive name: HUMAN NORMAL IMMUNOGLOBULIN (IV)
Biotest AGNULLNot Recruiting Female: yes
Male: yes
60 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noUnited States;Hungary;Spain;Russian Federation;Germany;United Kingdom
31NCT02822495
(ClinicalTrials.gov)
July 201630/6/2016Expanded Access Protocol for Tabelecleucel for Patients With Epstein-Barr Virus-Associated Viremia or MalignanciesExpanded Access Protocol for Providing Tabelecleucel to Patients With Epstein-Barr Virus-Associated Viremia or Malignancies for Whom There Are No Appropriate Alternative TherapiesEpstein-Barr Virus (EBV) Infections;Lymphoproliferative Disorders;EBV+ Associated Lymphoma;EBV+ Associated Post-transplant Lymphoproliferative Disease (EBV+ PTLD);Epstein-Barr Viremia;Lymphoma, AIDS-related;Epstein-Barr Virus-associated Lymphoproliferative Disease (EBV+ LPD) With Primary Immunodeficiency (PID);Leiomyosarcoma (LMS);Nasopharyngeal Carcinoma (NPC);Epstein-Barr Virus-associated Lymphoproliferative Disease (EBV+ LPD) With Acquired Immunodeficiency (AID);Solid Organ Transplant Complications;Stem Cell Transplant ComplicationsBiological: tabelecleucelAtara BiotherapeuticsNULLAvailableN/AN/AAllUnited States
32NCT02593188
(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
33NCT02503293
(ClinicalTrials.gov)
July 29, 20151/7/2015A Study to Compare Quality of Life and Satisfaction in Primary Immunodeficient Patients Treated With Subcutaneous Injections of Gammanorm® 165 mg/mL Administered With Two Different Delivery Devices: Injections Using Pump or Rapid PushA Randomised, Cross-over Study to Compare Quality of Life and Satisfaction in Primary Immunodeficient Patients Treated With Subcutaneous Injections of Gammanorm® 165 mg/mL Administered With Two Different Delivery Devices: Injections Using Pump or Rapid PushPrimary ImmunodeficiencyDevice: Chrono Super PID then Generic Syringe-Gammanorm;Device: Generic Syringe then Chrono Super PID-GammanormOctapharmaNULLCompleted18 YearsN/AAll30Phase 4Australia;Germany;Italy;United Kingdom
34NCT02490956
(ClinicalTrials.gov)
April 201530/3/2015Diagnostic Immunization With Rabies Vaccine in Patients With PIDDiagnostic Immunization With Rabies Vaccine in Patients With Primary Immunodeficiency DisordersPrimary ImmunodeficiencyBiological: Verorab® (PVRV; Purified Vero Cell Vaccine)Chulalongkorn UniversityNULLRecruiting12 Months60 YearsBoth40Phase 4Thailand
35NCT02180763
(ClinicalTrials.gov)
April 201423/6/2014Gammanorm Quality of Life Study in Immunodeficient Patients Using Rapid Push or PumpsA Randomized, Cross-over Study to Compare Quality of Life and Satisfaction in Primary Immunodeficient Patients Treated With Subcutaneous Injections of Gammanorm® 165 mg/mL According to the Delivery Device: Injections Using Pump or Rapid Push.Primary Immunodeficiency (PID)Biological: GammanormOctapharmaNULLCompleted18 YearsN/AAll31Phase 4France
36NCT01888484
(ClinicalTrials.gov)
March 201421/6/2013Study of Octanorm Subcutaneous IG in Patients With PIDClinical Phase III Study to Evaluate the Pharmacokinetics, Efficacy, Tolerability and Safety of Subcutaneous Human Immunoglobulin (Octanorm 16.5%) In Patients With Primary Immunodeficiency DiseasesPrimary Immune Deficiency DisorderBiological: octanorm 16.5%OctapharmaNULLCompleted2 Years75 YearsAll75Phase 3United States;Canada;Czechia;Hungary;Poland;Russian Federation;Slovakia;Czech Republic
37NCT01962415
(ClinicalTrials.gov)
February 4, 201410/10/2013Reduced Intensity Conditioning for Non-Malignant Disorders Undergoing UCBT, BMT or PBSCTA Phase II Study of Reduced Intensity Conditioning in Pediatric Patients and Young Adults =55 Years of Age With Non-Malignant Disorders Undergoing Umbilical Cord Blood, Bone Marrow, or Peripheral Blood Stem Cell TransplantationPrimary Immunodeficiency (PID);Congenital Bone Marrow Failure Syndromes;Inherited Metabolic Disorders (IMD);Hereditary Anemias;Inflammatory ConditionsDrug: Hydroxyurea;Drug: Alemtuzumab;Drug: Fludarabine;Drug: Melphalan;Drug: ThiotepaPaul SzabolcsNULLRecruiting2 Months55 YearsAll100Phase 2United States
38NCT01814800
(ClinicalTrials.gov)
February 20146/3/2013Pharmacokinetics, Efficacy, and Safety Study of RI-002 (IGIV) in Subjects With Primary Immunodeficiency Diseases (PIDD)An Open Label, Multicenter, Study to Evaluate the Pharmacokinetics, Efficacy and Safety of RI-002 (IGIV) in Subjects With Primary Immunodeficiency Diseases (PIDD)Primary Immune Deficiency DisorderBiological: RI-002ADMA Biologics, Inc.NULLCompleted2 Years75 YearsAll59Phase 3United States
39EUCTR2013-000620-34-GB
(EUCTR)
10/01/201409/08/2013A clinical trial with a subcutaneous immunoglobulin (LFB-IgSC) to evaluate its efficacy, its safety and its behaviour in human blood in patients with Primary Immunodeficiency (PID) syndromesA Multicentre Phase III Study on the Efficacy, Safety and Pharmacokinetics of LFB-IgSC in Patients with Primary Immunodeficiency (PID) Syndromes Primary Immunofediciency (PID) syndromes
MedDRA version: 14.1;Level: HLT;Classification code 10036700;Term: Primary immunodeficiency syndromes;System Organ Class: 100000004870;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Human Normal Immunoglobulin for subcutaneous administration
Product Code: LFB-IgSC
INN or Proposed INN: Human Normal immunoglobulin
Other descriptive name: HUMAN NORMAL IMMUNOGLOBULIN
LFB BiotechnologiesNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
55Phase 3France;Hungary;Poland;Ukraine;Germany;Italy;United Kingdom
40EUCTR2013-000620-34-DE
(EUCTR)
07/10/201305/08/2013A clinical trial with a subcutaneous immunoglobulin (LFB-IgSC) to evaluate its efficacy, its safety and its behaviour in human blood in patients with Primary Immunodeficiency (PID) syndromesA Multicentre Phase III Study on the Efficacy, Safety and Pharmacokinetics of LFB-IgSC in Patients with Primary Immunodeficiency (PID) Syndromes Primary Immunofediciency (PID) syndromes
MedDRA version: 14.1;Level: HLT;Classification code 10036700;Term: Primary immunodeficiency syndromes;System Organ Class: 100000004870;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Human Normal Immunoglobulin for subcutaneous administration
Product Code: LFB-IgSC
INN or Proposed INN: Human Normal immunoglobulin
Other descriptive name: HUMAN NORMAL IMMUNOGLOBULIN
LFB BiotechnologiesNULLNot RecruitingFemale: yes
Male: yes
55Phase 3France;Hungary;Poland;Ukraine;Germany;Italy;United Kingdom
41EUCTR2013-000620-34-HU
(EUCTR)
19/09/201301/08/2013A clinical trial with a subcutaneous immunoglobulin (LFB-IgSC) to evaluate its efficacy, its safety and its behaviour in human blood in patients with Primary Immunodeficiency (PID) syndromesA Multicentre Phase III Study on the Efficacy, Safety and Pharmacokinetics of LFB-IgSC in Patients with Primary Immunodeficiency (PID) Syndromes Primary Immunofediciency (PID) syndromes
MedDRA version: 16.0;Level: HLT;Classification code 10036700;Term: Primary immunodeficiency syndromes;System Organ Class: 100000004870;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Human Normal Immunoglobulin for subcutaneous administration
Product Code: LFB-IgSC
INN or Proposed INN: Human Normal immunoglobulin
Other descriptive name: HUMAN NORMAL IMMUNOGLOBULIN
LFB BiotechnologiesNULLNot RecruitingFemale: yes
Male: yes
55Phase 3France;Hungary;Poland;Ukraine;Germany;Italy;United Kingdom
42EUCTR2013-000620-34-IT
(EUCTR)
05/08/201330/07/2013A clinical trial with a subcutaneous immunoglobulin (LFB-IgSC) to evaluate its efficacy, its safety and its behaviour in human blood in patients with Primary Immunodeficiency (PID) syndromesA Multicentre Phase III Study on the Efficacy, Safety and Pharmacokinetics of LFB-IgSC in Patients with Primary Immunodeficiency (PID) Syndromes - NA Primary Immunofediciency (PID) syndromes
MedDRA version: 14.1;Level: HLT;Classification code 10036700;Term: Primary immunodeficiency syndromes;System Organ Class: 100000004870;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Human Normal Immunoglobulin for subcutaneous administration
Product Code: LFB-IgSC
INN or Proposed INN: Human Normal immunoglobulin
Other descriptive name: HUMAN NORMAL IMMUNOGLOBULIN
LFB BiotechnologiesNULLNot RecruitingFemale: yes
Male: yes
55Phase 3France;Hungary;Poland;Ukraine;Germany;United Kingdom;Italy
43EUCTR2010-023483-41-FR
(EUCTR)
24/04/201304/01/2011A MULTICENTER STUDY ON THE EFFICACY, SAFETY AND PHARMACOKINETICS OF I10E IN PATIENTS WITH PRIMARY IMMUNODEFICIENCY (PID)A MULTICENTER STUDY ON THE EFFICACY, SAFETY AND PHARMACOKINETICS OF I10E IN PATIENTS WITH PRIMARY IMMUNODEFICIENCY (PID) a primary immunodeficiency as defined by the ESID and validated by a reference centre :• X-linked agammaglobulinemia (XLA)• Autosomal recessive inherited agammaglobulinemia (including autosomal recessive hyper-IgM syndrome)• Common variable immunodeficiency (CVID)• IgG subclass deficiency (at least 2 subclasses) with clinical manifestations of immunodeficiency
MedDRA version: 12.1;Level: LLT;Classification code 10010112;Term: Common variable immunodeficiency
Product Name: HUMAN NORMAL IMMUNOGLOBULIN FOR
Product Code: I10E
INN or Proposed INN: HUMAN NORMAL IMMUNOGLOBULIN FOR INTRAVENOUS USE
LFB BIOTECHNOLOGIESNULLNot RecruitingFemale: yes
Male: yes
60Phase 3France;Hungary
44NCT01218438
(ClinicalTrials.gov)
January 20138/10/2010Phase 2/3 Study of IGSC, 20% in PIDDA Clinical Study of Immune Globulin Subcutaneous (Human), 20% Solution (IGSC, 20%) for the Evaluation of Efficacy, Safety, Tolerability and Pharmacokinetics in Subjects With Primary Immunodeficiency Diseases (PIDD)Primary Immunodeficiency Diseases (PID)Biological: Immune Globulin Intravenous (Human), 10% Solution;Drug: Immune Globulin Subcutaneous (Human), 20% SolutionBaxalta now part of ShireNULLCompleted2 YearsN/AAll86Phase 2/Phase 3United States;Canada
45NCT01581593
(ClinicalTrials.gov)
November 201216/4/2012Efficacy and Safety Study of Kedrion IVIG 10% to Treat Subjects With Primary Immunodeficiency (PID)Multicenter, Open-label, Historically Controlled, Phase III Study to Assess the Efficacy, Tolerability, Safety and Pharmacokinetics of Kedrion IVIG 10% in Adult and Pediatric Subjects With Primary Immunodeficiency (PID).Primary Immunodeficiency;Agammaglobulinemia;Hypogammaglobulinemia;Antibody DeficiencyBiological: Kedrion IVIG 10%Kedrion S.p.A.NULLActive, not recruiting2 Years70 YearsBoth50Phase 3United States;Canada
46EUCTR2012-000792-16-DE
(EUCTR)
03/09/201210/05/2012Study to evaluate the efficacy, metabolism and safety of human immuneglobulin in patients with primary immunodeficiency diseasesCLINICAL STUDY TO EVALUATE THE PHARMACOKINETICS, SAFETY AND EFFICACY OF OCTAGAM 5% IN PATIENTS WITH PRIMARY IMMUNODEFICIENCY DISEASES” primary immunodeficiency disease (PID)
MedDRA version: 14.1;Level: LLT;Classification code 10010112;Term: Common variable immunodeficiency;System Organ Class: 10021428 - Immune system disorders
MedDRA version: 14.1;Classification code 10049485;Term: Bruton's agammaglobulinemia;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Trade Name: Octagam 5%
Product Name: Octagam 5%
Other descriptive name: IMMUNOGLOBULIN G
OCTAPHARMA AGNULLNot RecruitingFemale: yes
Male: yes
23Czech Republic;Hungary;Germany
47NCT02327351
(ClinicalTrials.gov)
July 201218/12/2014TCR Alpha/Beta Depletion for HSCT From Haploidentical and Unrelated Donors in the Treatment of PIDPhase II/III Study of Allogeneic Hematopoietic Stem Cell Transplantation From Unrelated and Haploidentical Donors After TCR Alfa Beta Negative Selection in Pediatric Patients With Primary Immunodeficiency DiseasesPrimary Immune Deficiency Disorder;Hematopoietic Stem Cell TransplantationOther: Biological: TCR alfa beta T cell depletionFederal Research Institute of Pediatric Hematology, Oncology and ImmunologyNULLRecruiting1 Month18 YearsBoth60Phase 2/Phase 3Russian Federation
48EUCTR2012-000481-38-GB
(EUCTR)
28/06/201226/04/2012Assessment 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: 14.1;Level: HLT;Classification code 10036700;Term: Primary immunodeficiency syndromes;System 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
49EUCTR2012-000792-16-HU
(EUCTR)
14/06/201220/03/2012Study to evaluate the efficacy, metabolism and safety of human immuneglobulin in patients with primary immunodeficiency diseasesCLINICAL STUDY TO EVALUATE THE PHARMACOKINETICS, SAFETY AND EFFICACY OF OCTAGAM 5% IN PATIENTS WITH PRIMARY IMMUNODEFICIENCY DISEASES” primary immunodeficiency disease (PID)
MedDRA version: 14.1;Level: LLT;Classification code 10049485;Term: Bruton's agammaglobulinemia;System Organ Class: 10010331 - Congenital, familial and genetic disorders
MedDRA version: 14.1;Classification code 10010112;Term: Common variable immunodeficiency;System Organ Class: 10021428 - Immune system disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Trade Name: OCTAGAM 50 mg/ml oldatos infúzió
Product Name: Octagam 5%
Other descriptive name: IMMUNOGLOBULIN G
OCTAPHARMA AGNULLNot RecruitingFemale: yes
Male: yes
23Czech Republic;Hungary;Germany
50EUCTR2012-000792-16-CZ
(EUCTR)
29/05/201227/03/2012Study to evaluate the efficacy, metabolism and safety of human immuneglobulin in patients with primary immunodeficiency diseasesCLINICAL STUDY TO EVALUATE THE PHARMACOKINETICS, SAFETY AND EFFICACY OF OCTAGAM 5% IN PATIENTS WITH PRIMARY IMMUNODEFICIENCY DISEASES” primary immunodeficiency disease (PID)
MedDRA version: 14.1;Level: LLT;Classification code 10049485;Term: Bruton's agammaglobulinemia;System Organ Class: 10010331 - Congenital, familial and genetic disorders
MedDRA version: 14.1;Classification code 10010112;Term: Common variable immunodeficiency;System Organ Class: 10021428 - Immune system disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Trade Name: OCTAGAM
Product Name: Octagam 5%
Other descriptive name: IMMUNOGLOBULIN G
OCTAPHARMA AGNULLNot RecruitingFemale: yes
Male: yes
23Hungary;Czech Republic;Germany
51EUCTR2010-019459-23-BE
(EUCTR)
29/03/201214/02/2012CLINICAL 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: 16.0;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: 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
52NCT01485796
(ClinicalTrials.gov)
December 29, 20112/12/2011Tolerability and Safety of IGI, 10% With rHuPH20 in PIDDTolerability, Safety and Administration Mode Evaluation of Recombinant Human Hyaluronidase (rHuPH20) Facilitated Subcutaneous Treatment With Immune Globulin Infusion (Human), 10% in Subjects With Primary Immunodeficiency Diseases (PIDD)Primary Immunodeficiency Diseases (PID)Biological: Immune Globulin Infusion (Human), 10%;Biological: Recombinant human hyaluronidaseBaxalta now part of ShireNULLCompleted2 YearsN/AAll54Phase 2/Phase 3United States
53EUCTR2010-019459-23-NL
(EUCTR)
24/08/201127/01/2011CLINICAL 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: 16.0;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: 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
54NCT01412385
(ClinicalTrials.gov)
June 20, 20118/8/2011Immune Globulin Subcutaenous (Human), 20%A Clinical Study of Immune Globulin Subcutaneous (Human) (IGSC), 20% for the Evaluation of Efficacy, Safety, and Pharmacokinetics in Subjects With Primary Immunodeficiency DiseasesPrimary Immunodeficiency Diseases (PID)Biological: Immune Globulin Subcutaneous (Human), 20%;Biological: Immune Globulin Intravenous (Human), 10%;Biological: Human Normal Immunoglobulin (Subcutaneous - Intramuscular Immunoglobulin)Baxalta now part of ShireNULLCompleted2 YearsN/AAll55Phase 2/Phase 3Austria;Germany;Hungary;Sweden;United Kingdom
55EUCTR2010-019459-23-SE
(EUCTR)
23/03/201125/01/2011CLINICAL 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: 16.0;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: 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
56EUCTR2010-023483-41-HU
(EUCTR)
01/03/201110/11/2010A multinational study with I10E (Human Immunoglobulin) to demonstrate the efficacy and the safety of the product in patients suffering from deficiency in their immune systemA MULTICENTER STUDY ON THE EFFICACY, SAFETY AND PHARMACOKINETICS OF I10E IN PATIENTS WITH PRIMARY IMMUNODEFICIENCY (PID) - I10E-0718 a primary immunodeficiency as defined by the ESID and validated by a reference centre :• X-linked agammaglobulinemia (XLA)• Common variable immunodeficiency (CVID)
MedDRA version: 14.1;Level: LLT;Classification code 10010112;Term: Common variable immunodeficiency;System Organ Class: 100000004870
MedDRA version: 14.1;Level: HLT;Classification code 10036700;Term: Primary immunodeficiency syndromes;Classification code 10001471;Term: Agammaglobulinemia;System Organ Class: 100000004870;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: HUMAN NORMAL IMMUNOGLOBULIN FOR
Product Code: I10E
INN or Proposed INN: HUMAN NORMAL IMMUNOGLOBULIN FOR INTRAVENOUS USE
LFB BIOTECHNOLOGIESNULLNot RecruitingFemale: yes
Male: yes
60Serbia;France;Czech Republic;Hungary;Poland;Ukraine;Lithuania
57NCT01289847
(ClinicalTrials.gov)
March 201127/1/2011A Study to Find Out How Safe and Effective Gammaplex® is in Young People With Primary ImmunodeficiencyA Phase IV, Multicenter, Open-Label Study to Evaluate the Efficacy, Safety and Pharmacokinetics of Gammaplex in Primary Immunodeficiency Diseases (PID) in Children and AdolescentsPrimary Immune Deficiency Disorders;Common Variable Immunodeficiency;X-linked Agammaglobulinemia;Hyper-IgM Syndrome;Wiskott-Aldrich SyndromeBiological: GammaplexBio Products LaboratoryNULLCompleted2 Years16 YearsAll25Phase 4United States;Chile;Israel
58EUCTR2010-019459-23-DE
(EUCTR)
18/01/201128/07/2010CLINICAL 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: 16.1;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: 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
59EUCTR2010-019459-23-GB
(EUCTR)
21/12/201005/10/2010CLINICAL 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: 14.1;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: 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
60EUCTR2010-019459-23-HU
(EUCTR)
20/12/201020/10/2010CLINICAL 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: 16.0;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: 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
61EUCTR2010-019459-23-AT
(EUCTR)
05/11/201002/08/2010CLINICAL 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: 14.1;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: 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
62EUCTR2010-019249-25-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
63EUCTR2010-019249-25-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
64NCT01175213
(ClinicalTrials.gov)
July 28, 20103/8/2010Tolerability and Safety of Immune Globulin Subcutaneous Solution (IGSC) and rHuPH20 in PIDLong-Term Tolerability and Safety of Immune Globulin Subcutaneous (IGSC) Solution Administered Subcutaneously Following Administration of Recombinant Human Hyaluronidase (rHuPH20) in Subjects With Primary Immunodeficiency DiseasesPrimary Immunodeficiency Diseases (PID)Biological: SC treatment with IGSC, 10% with rHuPH20 followed by SC/IGSC, 10% only (safety);Biological: SC treatment with IGSC, 10% with rHuPH20 followed by IV/IGSC, 10% only (safety);Biological: IV treatment with IGSC, 10%Baxalta now part of ShireNULLCompleted2 YearsN/AAll66Phase 3United States
65EUCTR2007-002611-27-GB
(EUCTR)
19/02/201015/03/2010Clinical study to evaluate the efficacy, safety and kinetics of Octagam® 10% for replacement therapy in Primary Immunodeficiency Diseases (PID) - NAClinical study to evaluate the efficacy, safety and kinetics of Octagam® 10% for replacement therapy in Primary Immunodeficiency Diseases (PID) - NA Primary Immundeficiency Diseases (PID)
MedDRA version: 9.1;Level: LLT;Classification code 10064859;Term: Primary immunodeficiency syndrome
Trade Name: Octagam 10%
Product Name: Octagam 10%
Octapharma AGNULLNot Recruiting Female: yes
Male: yes
45 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noFrance;Germany;United Kingdom
66EUCTR2007-002611-27-FR
(EUCTR)
17/02/201026/11/2009Clinical study to evaluate the efficacy, safety and kinetics of Octagam® 10% for replacement therapy in Primary Immunodeficiency Diseases (PID) - NAClinical study to evaluate the efficacy, safety and kinetics of Octagam® 10% for replacement therapy in Primary Immunodeficiency Diseases (PID) - NA Primary Immunodeficiency Diseases (PID)
MedDRA version: 9.1;Level: LLT;Classification code 10064859;Term: Primary immunodeficiency syndrome
Trade Name: Octagam 10%
Product Name: Octagam 10%
INN or Proposed INN: Human Normal Immunoglobulin
Octapharma AGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
45United Kingdom;France
67NCT00814320
(ClinicalTrials.gov)
December 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
68EUCTR2008-000830-30-SE
(EUCTR)
17/12/200803/11/2008A Multicenter Extension Study of the Efficacy, Tolerability, and Safety of Immune Globulin Subcutaneous (Human) IgPro20 in Subjects with Primary Immunodeficiency(IgPro20 EU Extension Study)A Multicenter Extension Study of the Efficacy, Tolerability, and Safety of Immune Globulin Subcutaneous (Human) IgPro20 in Subjects with Primary Immunodeficiency(IgPro20 EU Extension Study) PID (primary immunodeficiency)
MedDRA version: 9.1;Level: LLT;Classification code 10064859;Term: Primary immunodeficiency syndrome
Product Name: IgPro20
Product Code: IgPro20
INN or Proposed INN: normal human immunoglobulin G
CSL Behring AGNULLNot RecruitingFemale: yes
Male: yes
36United Kingdom;Germany;France;Spain;Sweden
69EUCTR2008-000830-30-GB
(EUCTR)
10/12/200820/01/2009Extension study designed to test the long-term safety and effectiveness of Immunoglobulin Subcutaneous (Human), IgPro20. A Multicenter Extension Study of the Efficacy, Tolerability, and Safety of Immune Globulin Subcutaneous (Human) IgPro20 in Subjects with Primary Immunodeficiency (IgPro20 EU Extension Study) PID (Primary Immune Deficiency)
MedDRA version: 13.1;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]
Product Name: Hizentra®
Product Code: IgPro20
INN or Proposed INN: Human Normal Immunoglobulin
CSL Behring AGNULLNot Recruiting Female: yes
Male: yes
40 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noFrance;Spain;Poland;Romania;Germany;Switzerland;United Kingdom;Sweden
70EUCTR2008-000830-30-FR
(EUCTR)
24/11/200821/10/2008A Multicenter Extension Study of the Efficacy, Tolerability, and Safety of Immune Globulin Subcutaneous (Human) IgPro20 in Subjects with Primary Immunodeficiency(IgPro20 EU Extension Study)A Multicenter Extension Study of the Efficacy, Tolerability, and Safety of Immune Globulin Subcutaneous (Human) IgPro20 in Subjects with Primary Immunodeficiency(IgPro20 EU Extension Study) PID (primary immunodeficiency)
MedDRA version: 9.1;Level: LLT;Classification code 10064859;Term: Primary immunodeficiency syndrome
Product Name: IgPro20
Product Code: IgPro20
INN or Proposed INN: Human Normal Immunoglobulin
CSL Behring AGNULLNot RecruitingFemale: yes
Male: yes
36Phase 3France;Spain;Germany;United Kingdom;Sweden
71EUCTR2008-000830-30-ES
(EUCTR)
12/11/200801/10/2008A Multicenter Extension Study of the Efficacy, Tolerability, and Safety of ImmuneGlobulin Subcutaneous (Human) IgPro20 in Subjects with Primary Immunodeficiency(IgPro20 EU Extension Study)Un estudio de extensión multicéntrico sobre la eficacia, tolerabilidad y seguridad de la inmunoglobulina subcutánea (humana) IgPro20 en pacientes con inmunodeficiencia primaria(Estudio de extensión de la UE sobre IgPro20)A Multicenter Extension Study of the Efficacy, Tolerability, and Safety of ImmuneGlobulin Subcutaneous (Human) IgPro20 in Subjects with Primary Immunodeficiency(IgPro20 EU Extension Study)Un estudio de extensión multicéntrico sobre la eficacia, tolerabilidad y seguridad de la inmunoglobulina subcutánea (humana) IgPro20 en pacientes con inmunodeficiencia primaria(Estudio de extensión de la UE sobre IgPro20) Primary Immunodeficiency (PID)inmunodeficiencia primaria (IDP)
MedDRA version: 9.1;Level: LLT;Classification code 10064859;Term: Primary immunodeficiency syndrome
Product Name: IgPro20
Product Code: IgPro20
INN or Proposed INN: Human Normal Immunoglobulin
CSL Behring AGNULLNot RecruitingFemale: yes
Male: yes
36United Kingdom;Germany;France;Spain;Sweden
72EUCTR2007-002611-27-DE
(EUCTR)
27/10/200814/12/2007Clinical study to evaluate the efficacy, safety and kinetics of Octagam® 10% for replacement therapy in Primary Immunodeficiency Diseases (PID) - NAClinical study to evaluate the efficacy, safety and kinetics of Octagam® 10% for replacement therapy in Primary Immunodeficiency Diseases (PID) - NA Primary Immundeficiency Diseases (PID)
MedDRA version: 9.1;Level: LLT;Classification code 10064859;Term: Primary immunodeficiency syndrome
Trade Name: Octagam 10%
Product Name: Octagam 10%
Octapharma AGNULLNot RecruitingFemale: yes
Male: yes
45France;Germany;United Kingdom
73EUCTR2006-006745-13-PL
(EUCTR)
16/10/200811/08/2008A multicenter study of the efficacy, tolerability, safety, and pharmacokinetics of Immune Globuline Subcutaneous (Human) IgPro20 in subjects with Primary Immunodeficiency (PID) A multicenter study of the efficacy, tolerability, safety, and pharmacokinetics of Immune Globuline Subcutaneous (Human) IgPro20 in subjects with Primary Immunodeficiency (PID) PID (Primary Immunodeficiency)
MedDRA version: 9.1;Level: LLT;Classification code 10064859;Term: Primary immunodeficiency syndrome
Product Name: IgPro20
Other descriptive name: IMMUNOGLOBULIN G
CSL BehringNULLNot RecruitingFemale: yes
Male: yes
43Phase 3France;Spain;Poland;Germany;Italy;United Kingdom;Sweden
74NCT00751621
(ClinicalTrials.gov)
August 200811/9/2008Study of Subcutaneous Immune Globulin in Patients Requiring IgG Replacement Therapy (EU Extension Study)A Multicenter Extension Study of the Efficacy, Tolerability, and Safety of Immune Globulin Subcutaneous (Human) IgPro20 in Subjects With Primary Immunodeficiency (IgPro20 EU Extension Study)Primary Immunodeficiency (PID)Biological: IgPro20CSL BehringNULLCompleted2 Years65 YearsAll40Phase 3France;Germany;Poland;Romania;Spain;Sweden;Switzerland;United Kingdom
75EUCTR2008-000830-30-DE
(EUCTR)
10/07/200809/06/2008A Multicenter Extension Study of the Efficacy, Tolerability, and Safety of Immune Globulin Subcutaneous (Human) IgPro20 in Subjects with Primary Immunodeficiency(IgPro20 EU Extension Study)A Multicenter Extension Study of the Efficacy, Tolerability, and Safety of Immune Globulin Subcutaneous (Human) IgPro20 in Subjects with Primary Immunodeficiency(IgPro20 EU Extension Study) PID (primary immuno deficiency)
MedDRA version: 9.1;Level: LLT;Classification code 10064859;Term: Primary immunodeficiency syndrome
Product Name: IgPro20
Product Code: IgPro20
INN or Proposed INN: Human Normal Immunoglobulin
CSL Behring AGNULLNot RecruitingFemale: yes
Male: yes
36United Kingdom;Germany;France;Spain;Sweden
76NCT00719680
(ClinicalTrials.gov)
June 200821/7/2008Extension Study of Subcutaneous Immunoglobulin Human in Patients With Primary Immunodeficiency (PID)A Multicenter Extension Study of the Efficacy, Tolerability, and Safety of Immune Globulin Subcutaneous (Human) IgPro20 in Subjects With Primary Immunodeficiency (PID)Primary Immune DeficiencyBiological: IgPro20CSL BehringNULLCompleted2 Years75 YearsAll21Phase 3United States
77NCT00680446
(ClinicalTrials.gov)
April 200816/5/2008Safety Study of Subcutaneous Ig NextGen 16% in Patients With Primary ImmunodeficiencyAn Open-Label Study of Ig NextGen 16% Administered by Subcutaneous Infusion in Patients With Primary Immunodeficiency (PID).Primary Immune DeficiencyDrug: Immunoglobulin G (Ig NextGen 16%)CSL LimitedNULLCompleted3 YearsN/ABoth41Phase 3Australia;New Zealand
78EUCTR2006-006522-25-GR
(EUCTR)
08/01/200804/06/2007A multicenter study on the efficacy and safety of Vivaglobin® in Previously Untreated Patients (PUPs) with Primary Immunodeficiency (PID)A multicenter study on the efficacy and safety of Vivaglobin® in Previously Untreated Patients (PUPs) with Primary Immunodeficiency (PID) Patients with PID diseases as Common Variable Immunodeficiency (CVID) or X-linked agammaglobulinemia ( XLA), age 1 to 70 years
MedDRA version: 8.1;Level: LLT;Classification code 10010112;Term: Common variable immunodeficiency
Trade Name: Vivaglobin
Product Name: Vivaglobin
INN or Proposed INN: immune globulin subcutaneous (human)
CSL Behring AGNULLNot RecruitingFemale: yes
Male: yes
28Phase 4Greece;Spain;Belgium;Germany;Italy;United Kingdom
79NCT00546871
(ClinicalTrials.gov)
October 3, 200718/10/2007Comparison of Intravenous and Subcutaneous Administration of IGIV, 10% in Primary Immunodeficiency (PID) SubjectsTolerability and Pharmacokinetic Comparison of Immune Globulin Intravenous (Human) 10% (IGIV, 10%) Administered Intravenously or Subcutaneously in Subjects With Primary Immunodeficiency DiseasesPrimary Immunodeficiency Diseases (PID)Drug: Immune Globulin Intravenous (Human), 10%Baxalta now part of ShireNULLCompleted24 MonthsN/AAll49Phase 2/Phase 3United States
80EUCTR2006-006745-13-SE
(EUCTR)
19/09/200723/07/2007A Multicenter Study of the Efficacy, Tolerability, Safety, and Pharmacokinetics of Immune Globulin Subcutaneous (Human) IgPro20 in Subjects with Primary ImmunodeficiencyA Multicenter Study of the Efficacy, Tolerability, Safety, and Pharmacokinetics of Immune Globulin Subcutaneous (Human) IgPro20 in Subjects with Primary Immunodeficiency PID (Primary Immunodeficiency)
MedDRA version: 9.1;Level: LLT;Classification code 10064859;Term: Primary immunodeficiency syndrome
Product Name: IgPro20
Product Code: IgPro20
INN or Proposed INN: Human Immunglobulin G (IgG)
CSL Behring AGNULLNot RecruitingFemale: yes
Male: yes
51United Kingdom;Germany;France;Spain;Italy;Poland;Sweden
81EUCTR2006-006522-25-GB
(EUCTR)
10/09/200728/03/2007A multicenter study on the efficacy and safety of Vivaglobin® in Previously Untreated Patients (PUPs) with Primary Immunodeficiency (PID)A multicenter study on the efficacy and safety of Vivaglobin® in Previously Untreated Patients (PUPs) with Primary Immunodeficiency (PID) Patients with PID diseases as Common Variable Immunodeficiency (CVID) or X-linked agammaglobulinemia ( XLA), age 1 to 70 years
MedDRA version: 8.1;Level: LLT;Classification code 10010112;Term: Common variable immunodeficiency
Trade Name: Vivaglobin
Product Name: Vivaglobin
INN or Proposed INN: immune globulin subcutaneous (human)
CSL Behring AGNULLNot Recruiting Female: yes
Male: yes
28 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): yesGreece;Spain;Belgium;Germany;Italy;United Kingdom
82EUCTR2006-006745-13-IT
(EUCTR)
30/08/200701/08/2007A Multicenter Study of the Efficacy, Tolerability, Safety and Pharmacokinetics of Immune Globulin Subcutaneous (Human) IgPro20 in Subjects with Primary Immunodeficiency - NDA Multicenter Study of the Efficacy, Tolerability, Safety and Pharmacokinetics of Immune Globulin Subcutaneous (Human) IgPro20 in Subjects with Primary Immunodeficiency - ND PID (Primary Immunodeficiency)
MedDRA version: 6.1;Level: HLGT;Classification code 10021460
Product Name: IgPro20
Product Code: IgPro20
INN or Proposed INN: Immunoglobulins, normal human
CSL Behring AG (casa madre)NULLNot RecruitingFemale: yes
Male: yes
36United Kingdom;Germany;France;Spain;Italy;Poland;Sweden
83EUCTR2006-006745-13-ES
(EUCTR)
27/08/200711/06/2007Estudio multicéntrico sobre la eficacia, la tolerabilidad, la seguridad y la farmacocinética de la immunoglobulina subcutánea (humana) IgPro20 en sujetos con immunodeficiencia orimaria (PID)A Multicenter Study of the Efficacy, Tolerability, Safety, and Pharmacokinetics of Immune Globulin Subcutaneous (Human) IgPro20 in Subjects with Primary ImmunodeficiencyEstudio multicéntrico sobre la eficacia, la tolerabilidad, la seguridad y la farmacocinética de la immunoglobulina subcutánea (humana) IgPro20 en sujetos con immunodeficiencia orimaria (PID)A Multicenter Study of the Efficacy, Tolerability, Safety, and Pharmacokinetics of Immune Globulin Subcutaneous (Human) IgPro20 in Subjects with Primary Immunodeficiency immunodeficencia primaria (PID)
MedDRA version: 9.1;Level: LLT;Classification code 10064859;Term: Primary immunodeficiency syndrome
Product Name: IgPro20
Product Code: IgPro20
INN or Proposed INN: Human Immunglobulin G (IgG)
CSL Behring AGNULLNot RecruitingFemale: yes
Male: yes
36Phase 3France;Poland;Spain;Germany;Italy;United Kingdom;Sweden
84EUCTR2006-006522-25-IT
(EUCTR)
13/08/200731/07/2007A Multicenter study on the efficacy and safety of Vivaglobin in Previously Untreated Patients (PUPs) with Primary Immunodeficiency (PID) - NDA Multicenter study on the efficacy and safety of Vivaglobin in Previously Untreated Patients (PUPs) with Primary Immunodeficiency (PID) - ND Patients with PID diseases as Common Variable Immunodeficiency (CVID) or X-linked agammaglobulinemia ( XLA), age 1 to 70 years.
MedDRA version: 6.1;Level: PT;Classification code 10057863
Trade Name: Vivaglobin
INN or Proposed INN: immunglobulin (human)
CSL Behring AGNULLNot RecruitingFemale: yes
Male: yes
28United Kingdom;Germany;Belgium;Spain;Italy;Greece
85EUCTR2006-006745-13-GB
(EUCTR)
17/07/200715/05/2007A Multicenter Study of the Efficacy, Tolerability, Safety, and Pharmacokinetics of Immune Globulin Subcutaneous (Human) IgPro20 in Subjects with Primary ImmunodeficiencyA Multicenter Study of the Efficacy, Tolerability, Safety, and Pharmacokinetics of Immune Globulin Subcutaneous (Human) IgPro20 in Subjects with Primary Immunodeficiency PID (Primary Immunodeficiency)
MedDRA version: 9.1;Level: LLT;Classification code 10064859;Term: Primary immunodeficiency syndrome
Product Name: IgPro20
Product Code: IgPro20
INN or Proposed INN: Human Immunglobulin G (IgG)
CSL Behring AGNULLNot Recruiting Female: yes
Male: yes
51 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noFrance;Poland;Spain;Germany;Italy;United Kingdom;Sweden
86EUCTR2006-006745-13-DE
(EUCTR)
11/07/200721/03/2007A Multicenter Study of the Efficacy, Tolerability, Safety, and Pharmacokinetics of Immune Globulin Subcutaneous (Human) IgPro20 in Subjects with Primary ImmunodeficiencyA Multicenter Study of the Efficacy, Tolerability, Safety, and Pharmacokinetics of Immune Globulin Subcutaneous (Human) IgPro20 in Subjects with Primary Immunodeficiency PID (Primary Immunodeficiency)
MedDRA version: 9.1;Level: LLT;Classification code 10064859;Term: Primary immunodeficiency syndrome
Product Name: IgPro20
Product Code: IgPro20
INN or Proposed INN: Human Immunglobulin G (IgG)
CSL Behring AGNULLNot RecruitingFemale: yes
Male: yes
51United Kingdom;Germany;France;Spain;Italy;Poland;Sweden
87EUCTR2006-006745-13-FR
(EUCTR)
10/07/200704/06/2007A Multicenter Study of the Efficacy, Tolerability, Safety, and Pharmacokinetics of Immune Globulin Subcutaneous (Human) IgPro20 in Subjects with Primary ImmunodeficiencyA Multicenter Study of the Efficacy, Tolerability, Safety, and Pharmacokinetics of Immune Globulin Subcutaneous (Human) IgPro20 in Subjects with Primary Immunodeficiency PID (Primary Immunodeficiency)
MedDRA version: 9.1;Level: LLT;Classification code 10064859;Term: Primary immunodeficiency syndrome
Product Name: IgPro20
Product Code: IgPro20
INN or Proposed INN: Human Immunglobulin G (IgG)
CSL Behring AGNULLNot RecruitingFemale: yes
Male: yes
36Phase 3France;Poland;Spain;Germany;Italy;United Kingdom;Sweden
88EUCTR2006-006522-25-ES
(EUCTR)
01/07/200703/03/2010Estudio multicéntrico sobre la eficacia y la seguridad de Vivaglobin® en pacientes sin tratamiento previo (PUP) con inmunodeficiencia primaria (PID)(A multicenter study on the efficacy and safety of Vivaglobin® in Previously Untreated Patients (PUPs) with Primary Immunodeficiency (PID))Estudio multicéntrico sobre la eficacia y la seguridad de Vivaglobin® en pacientes sin tratamiento previo (PUP) con inmunodeficiencia primaria (PID)(A multicenter study on the efficacy and safety of Vivaglobin® in Previously Untreated Patients (PUPs) with Primary Immunodeficiency (PID)) Pacientes con inmunodeficiencia primaria como inmunodeficiencia variable común (CVID) o agammaglobulinemia vinculada al cromosoma X (XLA) de entre 1 y 70 años de edad.(Patients with PID diseases as Common Variable Immunodeficiency (CVID) or X-linked agammaglobulinemia ( XLA), age 1 to 70 years)
MedDRA version: 8.1;Level: LLT;Classification code 10010112;Term: Common variable immunodeficiency
Trade Name: Vivaglobin
Product Name: Vivaglobin
INN or Proposed INN: immune globulin subcutaneous (human)
CSL Behring AGNULLNot RecruitingFemale: yes
Male: yes
28Phase 4Greece;Belgium;Spain;Germany;Italy;United Kingdom
89EUCTR2006-006522-25-BE
(EUCTR)
27/06/200717/04/2007A multicenter study on the efficacy and safety of Vivaglobin® in Previously Untreated Patients (PUPs) with Primary Immunodeficiency (PID)A multicenter study on the efficacy and safety of Vivaglobin® in Previously Untreated Patients (PUPs) with Primary Immunodeficiency (PID) Patients with PID diseases as Common Variable Immunodeficiency (CVID) or X-linked agammaglobulinemia ( XLA), age 1 to 70 years
MedDRA version: 8.1;Level: LLT;Classification code 10010112;Term: Common variable immunodeficiency
Trade Name: Vivaglobin
Product Name: Vivaglobin
INN or Proposed INN: immune globulin subcutaneous (human)
CSL Behring AGNULLNot RecruitingFemale: yes
Male: yes
28United Kingdom;Germany;Belgium;Spain;Italy;Greece
90NCT00391131
(ClinicalTrials.gov)
April 200720/10/2006Subcutaneous Ig NextGen 16% in PID PatientsA Multi-centre, Open-label Study to Assess the Efficacy, Tolerability, Safety and Pharmacokinetics of Subcutaneous Infusions of Ig NextGen 16% in Patients With Primary Immunodeficiency (PID).Primary Immunodeficiency (PID)Drug: IgNextGen 16%CSL LimitedNULLCompleted3 YearsN/ABoth35Phase 3Australia;New Zealand
91NCT00520494
(ClinicalTrials.gov)
March 200723/8/2007Efficacy and Safety of Vivaglobin® in Previously Untreated Patients With Primary ImmunodeficiencyA Multicenter Study on the Efficacy and Safety of Vivaglobin® in Previously Untreated Patients (PUPs) With Primary Immunodeficiency (PID)Common Variable Immunodeficiency;AgammaglobulinemiaDrug: VivaglobinCSL BehringNULLCompleted1 Year70 YearsAll18Phase 4Canada;Germany;Italy;Spain;Belgium
92EUCTR2006-006522-25-DE
(EUCTR)
01/02/200707/12/2006A multicenter study on the efficacy and safety of Vivaglobin® in Previously Untreated Patients (PUPs) with Primary Immunodeficiency (PID)A multicenter study on the efficacy and safety of Vivaglobin® in Previously Untreated Patients (PUPs) with Primary Immunodeficiency (PID) Patients with PID diseases as Common Variable Immunodeficiency (CVID) or X-linked agammaglobulinemia ( XLA), age 1 to 70 years
MedDRA version: 8.1;Level: LLT;Classification code 10010112;Term: Common variable immunodeficiency
Trade Name: Vivaglobin
Product Name: Vivaglobin
INN or Proposed INN: immune globulin subcutaneous (human)
CSL Behring AGNULLNot RecruitingFemale: yes
Male: yes
28United Kingdom;Germany;Belgium;Spain;Italy;Greece
93NCT00782106
(ClinicalTrials.gov)
December 4, 200629/10/2008Study to Determine the Dose of Recombinant Human Hyaluronidase Needed to Infuse a Full Dose of IGIV SubcutaneouslyPhase 1/2 Determination of the Dose of Recominant Human Hyaluronidase (rHuPH20) Required Enabling Up to 600 mg/kg Bodyweight of IGIV, 10% to be Administered Subcutaneously in a Single Infusion Site in Subjects With Primary Immunodeficiency (PID)Primary Immunodeficiency Diseases (PID)Biological: Recombinant human hyaluronidase + immune globulin intravenousBaxalta now part of ShireNULLCompleted16 YearsN/AAll11Phase 1/Phase 2United States
94NCT00419341
(ClinicalTrials.gov)
November 200622/12/2006Study of Subcutaneous Immunoglobulin in Patients With PID Requiring IgG Replacement TherapyA Phase III Open-Label, Prospective, Multicenter Study of the Efficacy, Tolerability, Safety, and Pharmacokinetics of Immune Globulin Subcutaneous (Human), IgPro20 in Subjects With Primary Immunodeficiency (PID)Primary Immune DeficiencyBiological: Human Normal Immunoglobulin for Subcutaneous AdministrationCSL BehringNULLCompleted2 Years75 YearsAll49Phase 3United States
95NCT00322556
(ClinicalTrials.gov)
November 20055/5/2006Safety and Efficacy of Intravenous Immunoglobulin IgPro10 in Patients With Primary Immunodeficiencies (PID)A Multicenter Extension Study on the Safety and Efficacy of IgPro10 in Patients With Primary Immunodeficiency (PID)Agammaglobulinemia;IgG Deficiency;Common Variable ImmunodeficiencyDrug: Immunoglobulins Intravenous (Human)CSL BehringNULLCompleted4 Years71 YearsAll55Phase 3United States
96EUCTR2004-004465-15-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
97EUCTR2004-004465-15-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
98NCT00168025
(ClinicalTrials.gov)
September 200412/9/2005Efficacy and Safety of Intravenous Immunoglobulin IgPro10 in Patients With Primary Immunodeficiencies (PID)A Multicenter Study on the Efficacy, Safety and Pharmacokinetics of IgPro10 in Patients With Primary Immunodeficiency (PID)Agammaglobulinemia;IgG Deficiency;Common Variable ImmunodeficiencyDrug: Immunoglobulins Intravenous (Human)CSL BehringNULLCompleted3 Years70 YearsBoth89Phase 3NULL
99NCT00168012
(ClinicalTrials.gov)
September 200412/9/2005Efficacy and Safety of Intravenous Immunoglobulin IVIG-F10 in Patients With Primary Immunodeficiencies (PID)An Open Study to Evaluate the Safety and Efficacy of IVIG-F10 in Patients With Primary Immunodeficiency Diseases (PID)Agammaglobulinemia;IgG Deficiency;Common Variable ImmunodeficiencyDrug: Immunoglobulins Intravenous (Human)CSL BehringNULLCompleted3 Years70 YearsBoth42Phase 3NULL
100NCT00157079
(ClinicalTrials.gov)
June 25, 20028/9/2005Safety and Efficacy Study of a 10% Intravenous Immune Globulin Solution in Subjects With Primary Immunodeficiency DisordersA Clinical Investigation to Assess the Safety and Efficacy of Immune Globulin Intravenous (Human), 10% in Subjects With Primary Immunodeficiency DisordersPrimary Immunodeficiency Diseases (PID);Immune Thrombocytopenic Purpura (ITP);Kawasaki SyndromeBiological: Immune Globulin Intravenous (Human), 10%Baxalta now part of ShireNULLCompleted24 MonthsN/AAll61Phase 3United States
101NCT00161993
(ClinicalTrials.gov)
June 13, 20028/9/2005Safety, Pharmacokinetic and Efficacy Study of a 10% Triple Virally Reduced Intravenous Immune Globulin Solution in Patients With Primary Immunodeficiency (Hypo- or Agammaglobulinemia)Prospective Open-Label Study of Pharmacokinetics, Efficacy and Safety of Immune Globulin Intravenous (Human), 10% TVR Solution in Patients With Hypo- or AgammaglobulinemiaPrimary Immunodeficiency Diseases (PID);Agammaglobulinemia;HypogammaglobulinemiaDrug: Immune Globulin Intravenous (Human), 10% TVR (Triple Virally Reduced) Solution;Drug: Gammagard S/D (Solvent/Detergent)Baxalta now part of ShireNULLCompleted18 YearsN/AAll24Phase 2Finland;Sweden
102EUCTR2011-005679-18-Outside-EU/EEA
(EUCTR)
07/12/2011A research study to determine if Gammaplex®, is safe, tolerable, and effective when given to children and adolescents who have Primary Immunodeficiency Diseases (PID)A Phase IV, Multicenter, Open-Label Study to Evaluate the Efficacy, Safety and Pharmacokinetics of Gammaplex in Primary Immunodeficiency Diseases (PID) in Children and Adolescents - n/a Primary immunodeficiency diseases
MedDRA version: 14.0;Level: SOC;Classification code 10005329;Term: Blood and lymphatic system disorders;System Organ Class: 10005329 - Blood and lymphatic system disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Trade Name: Gammaplex
Product Name: Gammaplex
Product Code: n/a
INN or Proposed INN: HUMAN NORMAL IMMUNOGLOBULIN
Other descriptive name: HUMAN NORMAL IMMUNOGLOBULIN
Bio Products Laboratory LimitedNULLNAFemale: yes
Male: yes
25Phase 4Chile;United States
103EUCTR2016-003799-33-Outside-EU/EEA
(EUCTR)
30/01/2017Safety and tolerability of higher infusion parameters of IgPro20 (Hizentra) in subjects with primary immunodeficiency (PID)An open-label multicenter study to evaluate the safety and tolerability of higher infusion parameters of immune globulin subcutaneous (human), 20% liquid (Hizentra®) in subjects with primary immunodeficiency Primary immunodeficiency
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: Hizentra
Product Name: Hizentra; human normal immunoglobulin (subcutaneous)
Product Code: IgPro20
INN or Proposed INN: Human normal immunoglobulin
Other descriptive name: HUMAN NORMAL IMMUNOGLOBULIN
CSL Behring LLCNULLNAFemale: yes
Male: yes
51Phase 4United States;Canada
104EUCTR2014-003607-30-Outside-EU/EEA
(EUCTR)
26/02/2015Study of Subcutaneous Immunoglobulin in Patients With PID Requiring IgG Replacement TherapyA Phase III Open-Label, Prospective, Multicenter Study of the Efficacy, Tolerability, Safety, and Pharmacokinetics of Immune Globulin Subcutaneous (Human), IgPro20 in Subjects With Primary Immunodeficiency (PID) Primary Immune Deficiency
MedDRA version: 17.1;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: Hizentra®
Product Name: IgPro20
Product Code: IgPro20
INN or Proposed INN: Human Normal Immunoglobulin
Other descriptive name: HUMAN NORMAL IMMUNOGLOBULIN
CSL Behring AGNULLNAFemale: yes
Male: yes
49Phase 3United States
105EUCTR2016-003438-26-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
106EUCTR2014-003772-23-Outside-EU/EEA
(EUCTR)
14/04/2015Safety and Efficacy of Intravenous Immunoglobulin IgPro10 in Patients With Primary Immunodeficiencies (PID)A Multicenter Extension Study on the Safety and Efficacy of IgPro10 in Patients With Primary Immunodeficiency (PID) Primary Immune Deficiency (Common Variable Immunodeficiency and X-linked agammaglobulinemia)
MedDRA version: 17.1;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: Privigen®
Product Name: Privigen®
INN or Proposed INN: Human Normal Immunoglobulin G (IgG > 98% purity)
Other descriptive name: HUMAN NORMAL IMMUNOGLOBULIN
CSL Behring AGNULLNAFemale: yes
Male: yes
55United States
107EUCTR2010-023483-41-Outside-EU/EEA
(EUCTR)
11/04/2014A multinational study with I10E (Human Immunoglobulin) to demonstrate the efficacy and the safety of the product in patients suffering from deficiency in their immune systemA MULTICENTER STUDY ON THE EFFICACY, SAFETY AND PHARMACOKINETICS OF I10E IN PATIENTS WITH PRIMARY IMMUNODEFICIENCY (PID) a primary immunodeficiency as defined by the ESID and validated by a reference centre :• X-linked agammaglobulinemia (XLA)• Common variable immunodeficiency (CVID)
MedDRA version: 16.1;Level: LLT;Classification code 10010112;Term: Common variable immunodeficiency;System Organ Class: 100000004870
MedDRA version: 16.1;Level: HLT;Classification code 10036700;Term: Primary immunodeficiency syndromes;Classification code 10001471;Term: Agammaglobulinemia;System Organ Class: 100000004870;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: HUMAN NORMAL IMMUNOGLOBULIN FOR
Product Code: I10E
INN or Proposed INN: HUMAN NORMAL IMMUNOGLOBULIN FOR INTRAVENOUS USE
LFB BIOTECHNOLOGIESNULLNAFemale: yes
Male: yes
60Poland;Serbia;Czech Republic;France;Hungary;Lithuania;Ukraine
108EUCTR2014-003605-15-Outside-EU/EEA
(EUCTR)
26/02/2015Extension Study of Subcutaneous Immunoglobulin Human in Patients With Primary Immunodeficiency (PID)A Multicenter Extension Study of the Efficacy, Tolerability, and Safety of Immune Globulin Subcutaneous (Human) IgPro20 in Subjects With Primary Immunodeficiency (PID) Primary Immune Deficiency (PID)
MedDRA version: 17.1;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: Hizentra®
INN or Proposed INN: Human Normal Immunoglobulin
Other descriptive name: HUMAN NORMAL IMMUNOGLOBULIN
CSL Behring AGNULLNAFemale: yes
Male: yes
21United States