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


臨床試験数 : 500 薬物数 : 614 - (DrugBank : 119) / 標的遺伝子数 : 92 - 標的パスウェイ数 : 217

  
46 trials found
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1NCT04346108
(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
2EUCTR2015-003290-15-HU
(EUCTR)
01/09/201712/05/2017A Multi-Centre, Open-Label, Single Arm Trial to Evaluate Efficacy, Pharmacokinetics, and Safety and Tolerability of IGSC 20% in Subjects with Primary ImmunodeficiencyA Multi-Centre, Open-Label, Single Arm Trial to Evaluate Efficacy, Pharmacokinetics, and Safety and Tolerability of IGSC 20% in Subjects with Primary Immunodeficiency - GTI1503 Primary Immunodeficiency (PI) diseases
MedDRA version: 20.0;Level: PT;Classification code 10061598;Term: Immunodeficiency;System Organ Class: 10021428 - Immune system disorders
MedDRA version: 20.0;Level: LLT;Classification code 10045792;Term: Unspecified disorder of immune mechanism;Classification code 10064859;Term: Primary immunodeficiency syndrome;System Organ Class: 10010331 - Congenital, familial and genetic disorders ;Therapeutic area: Body processes [G] - Immune system processes [G12]
Product Name: Immune Globulin Subcutaneous (Human), 20% Caprylate/Chromatography Purified (IGSC 20%)
Product Code: IGSC 20%
INN or Proposed INN: Immune Globulin Subcutaneous (Human), 20%, Caprylate/Chromatography Purified
Grifols Therapeutics Inc.NULLNot 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): noFrance;Czech Republic;Hungary;Poland;Spain;Australia;Germany;United Kingdom;Sweden
3NCT03033745
(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
4EUCTR2015-003290-15-DE
(EUCTR)
12/07/201616/03/2016A Multi-Centre, Open-Label, Single Arm Trial to Evaluate Efficacy, Pharmacokinetics, and Safety and Tolerability of IGSC 20% in Subjects with Primary ImmunodeficiencyA Multi-Centre, Open-Label, Single Arm Trial to Evaluate Efficacy, Pharmacokinetics, and Safety and Tolerability of IGSC 20% in Subjects with Primary Immunodeficiency - GTI1503 Primary Immunodeficiency (PI) diseases
MedDRA version: 20.0;Level: PT;Classification code 10061598;Term: Immunodeficiency;System Organ Class: 10021428 - Immune system disorders
MedDRA version: 20.0;Level: LLT;Classification code 10045792;Term: Unspecified disorder of immune mechanism;Classification code 10064859;Term: Primary immunodeficiency syndrome;System Organ Class: 10010331 - Congenital, familial and genetic disorders ;Therapeutic area: Body processes [G] - Immune system processes [G12]
Product Name: Immune Globulin Subcutaneous (Human), 20% Caprylate/Chromatography Purified (IGSC 20%)
Product Code: IGSC 20%
INN or Proposed INN: Immune Globulin Subcutaneous (Human), 20%, Caprylate/Chromatography Purified
Grifols Therapeutics Inc.NULLNot 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): noFrance;Hungary;Czech Republic;Poland;Spain;Australia;Germany;United Kingdom;Sweden
5EUCTR2015-003290-15-FR
(EUCTR)
29/06/201628/09/2018A Multi-Centre, Open-Label, Single Arm Trial to Evaluate Efficacy, Pharmacokinetics, and Safety and Tolerability of IGSC 20% in Subjects with Primary ImmunodeficiencyA Multi-Centre, Open-Label, Single Arm Trial to Evaluate Efficacy, Pharmacokinetics, and Safety and Tolerability of IGSC 20% in Subjects with Primary Immunodeficiency - GTI1503 Primary Immunodeficiency (PI) diseases
MedDRA version: 20.0;Level: PT;Classification code 10061598;Term: Immunodeficiency;System Organ Class: 10021428 - Immune system disorders
MedDRA version: 20.1;Level: LLT;Classification code 10045792;Term: Unspecified disorder of immune mechanism;System Organ Class: 10021428 - Immune system disorders
MedDRA version: 20.0;Classification code 10064859;Term: Primary immunodeficiency syndrome;System Organ Class: 10010331 - Congenital, familial and genetic disorders ;Therapeutic area: Body processes [G] - Immune system processes [G12]
Product Name: Immune Globulin Subcutaneous (Human), 20% Caprylate/Chromatography Purified (IGSC 20%)
Product Code: IGSC 20%
INN or Proposed INN: Immune Globulin Subcutaneous (Human), 20%, Caprylate/Chromatography Purified
Grifols Therapeutics Inc.NULLNot 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): noFrance;Hungary;Czech Republic;Poland;Spain;Germany;United Kingdom
6EUCTR2015-003290-15-CZ
(EUCTR)
22/06/201601/02/2016A Multi-Centre, Open-Label, Single Arm Trial to Evaluate Efficacy, Pharmacokinetics, and Safety and Tolerability of IGSC 20% in Subjects with Primary ImmunodeficiencyA Multi-Centre, Open-Label, Single Arm Trial to Evaluate Efficacy, Pharmacokinetics, and Safety and Tolerability of IGSC 20% in Subjects with Primary Immunodeficiency - GTI1503 Primary Immunodeficiency (PI) diseases
MedDRA version: 20.0;Level: PT;Classification code 10061598;Term: Immunodeficiency;System Organ Class: 10021428 - Immune system disorders
MedDRA version: 20.1;Level: LLT;Classification code 10045792;Term: Unspecified disorder of immune mechanism;System Organ Class: 10021428 - Immune system disorders
MedDRA version: 20.0;Classification code 10064859;Term: Primary immunodeficiency syndrome;System Organ Class: 10010331 - Congenital, familial and genetic disorders ;Therapeutic area: Body processes [G] - Immune system processes [G12]
Product Name: Immune Globulin Subcutaneous (Human), 20% Caprylate/Chromatography Purified (IGSC 20%)
Product Code: IGSC 20%
INN or Proposed INN: Immune Globulin Subcutaneous (Human), 20%, Caprylate/Chromatography Purified
Grifols Therapeutics Inc.NULLNot 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): noFrance;Hungary;Czech Republic;Poland;Spain;Germany;United Kingdom
7EUCTR2015-003290-15-GB
(EUCTR)
12/05/201613/01/2016A Multi-Centre, Open-Label, Single Arm Trial to Evaluate Efficacy, Pharmacokinetics, and Safety and Tolerability of IGSC 20% in Subjects with Primary ImmunodeficiencyA Multi-Centre, Open-Label, Single Arm Trial to Evaluate Efficacy, Pharmacokinetics, and Safety and Tolerability of IGSC 20% in Subjects with Primary Immunodeficiency - GTI1503 Primary Immunodeficiency (PI) diseases
MedDRA version: 20.0;Level: PT;Classification code 10061598;Term: Immunodeficiency;System Organ Class: 10021428 - Immune system disorders
MedDRA version: 20.0;Level: LLT;Classification code 10045792;Term: Unspecified disorder of immune mechanism;Classification code 10064859;Term: Primary immunodeficiency syndrome;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Body processes [G] - Immune system processes [G12]
Product Name: Immune Globulin Subcutaneous (Human), 20% Caprylate/Chromatography Purified (IGSC 20%)
Product Code: IGSC 20%
INN or Proposed INN: Immune Globulin Subcutaneous (Human), 20%, Caprylate/Chromatography Purified
Grifols Therapeutics Inc.NULLNot RecruitingFemale: yes
Male: yes
60Phase 3France;Hungary;Czech Republic;Spain;Poland;Australia;Germany;United Kingdom;Sweden
8EUCTR2015-003290-15-ES
(EUCTR)
12/04/201622/02/2016A Multi-Centre, Open-Label, Single Arm Trial to Evaluate Efficacy, Pharmacokinetics, and Safety and Tolerability of IGSC 20% in Subjects with Primary ImmunodeficiencyA Multi-Centre, Open-Label, Single Arm Trial to Evaluate Efficacy, Pharmacokinetics, and Safety and Tolerability of IGSC 20% in Subjects with Primary Immunodeficiency - GTI1503 Primary Immunodeficiency (PI) diseases
MedDRA version: 18.1;Level: PT;Classification code 10061598;Term: Immunodeficiency;System Organ Class: 10021428 - Immune system disorders
MedDRA version: 18.1;Level: LLT;Classification code 10045792;Term: Unspecified disorder of immune mechanism;Classification code 10064859;Term: Primary immunodeficiency syndrome;System Organ Class: 10010331 - Congenital, familial and genetic disorders ;Therapeutic area: Body processes [G] - Immune system processes [G12]
Product Name: Immune Globulin Subcutaneous (Human), 20% Caprylate/Chromatography Purified (IGSC 20%)
Product Code: IGSC 20%
INN or Proposed INN: Immune Globulin Subcutaneous (Human), 20%, Caprylate/Chromatography Purified
Grifols Therapeutics Inc.NULLNot 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): noFrance;Hungary;Czech Republic;Poland;Spain;Germany;United Kingdom
9NCT01218438
(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
10EUCTR2010-019459-23-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
11NCT01461018
(ClinicalTrials.gov)
October 201124/10/2011Multicenter Study of Long-Term Clinical Outcomes of Subcutaneous Immune Globulin IgPro20 in Subjects With Primary Immunodeficiency (Japan Study)A Multicenter Study of Long-Term Clinical Outcomes of Immune Globulin Subcutaneous (Human) (SCIG) IgPro20 in Subjects With Primary ImmunodeficiencyPrimary Immune DeficiencyBiological: Immune globulin subcutaneous (Human)CSL BehringNULLCompletedN/A75 YearsBoth22Phase 3Japan
12EUCTR2010-019459-23-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
13NCT01412385
(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
14NCT01458171
(ClinicalTrials.gov)
April 201112/10/2011Follow-up Study of Subcutaneous Immune Globulin in Patients Requiring IgG Replacement Therapy (Japan Study)A Multicenter Follow-up Study of Long-term Safety, Tolerability, and Efficacy of Immune Globulin Subcutaneous (Human) IgPro20 in Subjects With Primary ImmunodeficiencyPrimary Immune Deficiency DisorderBiological: Immune globulin subcutaneous (Human)CSL BehringNULLCompletedN/A75 YearsAll23Phase 3Japan
15EUCTR2010-019459-23-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
16EUCTR2010-019459-23-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
17EUCTR2010-019459-23-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
18EUCTR2010-019459-23-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
19EUCTR2010-019459-23-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
20NCT01199705
(ClinicalTrials.gov)
September 20108/9/2010Study of Subcutaneous Immune Globulin in Patients Requiring IgG Replacement Therapy (Japan Study)A Multicenter Study of Efficacy, Safety, Tolerability, and Pharmacokinetics of Immune Globulin Subcutaneous (Human) IgPro20 in Subjects With Primary ImmunodeficiencyPrimary Immune DeficiencyBiological: Immune Globulin Subcutaneous (Human) (SCIG)CSL BehringNULLCompletedN/A75 YearsAll25Phase 3Japan
21EUCTR2008-000830-30-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
22EUCTR2008-000830-30-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
23EUCTR2008-000830-30-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
24NCT00751621
(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
25EUCTR2008-000830-30-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
26NCT00719680
(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
27EUCTR2006-006522-25-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
28EUCTR2006-006745-13-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
29EUCTR2006-006522-25-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
30NCT00542997
(ClinicalTrials.gov)
September 200711/10/2007Study of Subcutaneous Immune Globulin in Patients Requiring IgG Replacement TherapyA Multicentre Study of the Efficacy, Tolerability, Safety, and Pharmacokinetics of Immune Globulin Subcutaneous (Human) IgPro20 in Subjects With Primary ImmunodeficiencyCommon Variable Immunodeficiency;X-linked Agammaglobulinemia;Autosomal Recessive AgammaglobulinemiaBiological: Human Normal Immunoglobulin for Subcutaneous Administration (IGSC)CSL BehringNULLCompleted2 Years65 YearsAll51Phase 3France;Germany;Italy;Poland;Romania;Spain;Sweden;Switzerland;United Kingdom
31EUCTR2006-006745-13-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
32EUCTR2006-006745-13-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
33EUCTR2006-006745-13-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
34EUCTR2006-006745-13-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
35EUCTR2006-006745-13-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
36EUCTR2006-006522-25-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
37EUCTR2006-006522-25-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
38EUCTR2006-006522-25-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
39NCT00419341
(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
40EUCTR2014-003605-15-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
41EUCTR2014-003409-13-Outside-EU/EEA
(EUCTR)
05/01/2015Multicenter Study of Long-Term Clinical Outcomes of Subcutaneous Immune Globulin IgPro20 in Subjects with Primary Immunodeficiency (Japan Study)A Multicenter Study of Long-Term Clinical Outcomes of Immune Globulin Subcutaneous (Human) (SCIG) IgPro20 in Subjects with Primary Immunodeficiency Primary Immune Deficiency;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 BehringNULLNAFemale: yes
Male: yes
22Japan
42EUCTR2014-003609-14-Outside-EU/EEA
(EUCTR)
05/01/2015Follow-up Study of Subcutaneous Immune Globulin in Patients Requiring IgG Replacement Therapy (Japan Study)A Multicenter Follow-up Study of Long-term Safety, Tolerability, and Efficacy of Immune Globulin Subcutaneous (Human) IgPro20 in Subjects With Primary Immunodeficiency Primary Immune Deficiency;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 BehringNULLNAFemale: yes
Male: yes
23Japan
43EUCTR2015-003290-15-PL
(EUCTR)
15/12/2016A Multi-Centre, Open-Label, Single Arm Trial to Evaluate Efficacy, Pharmacokinetics, and Safety and Tolerability of IGSC 20% in Subjects with Primary ImmunodeficiencyA Multi-Centre, Open-Label, Single Arm Trial to Evaluate Efficacy, Pharmacokinetics, and Safety and Tolerability of IGSC 20% in Subjects with Primary Immunodeficiency - GTI1503 Primary Immunodeficiency (PI) diseases
MedDRA version: 20.1;Level: LLT;Classification code 10045792;Term: Unspecified disorder of immune mechanism;System Organ Class: 10021428 - Immune system disorders
MedDRA version: 20.0;Level: PT;Classification code 10061598;Term: Immunodeficiency;Classification code 10064859;Term: Primary immunodeficiency syndrome;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Body processes [G] - Immune system processes [G12]
Product Name: Immune Globulin Subcutaneous (Human), 20% Caprylate/Chromatography Purified (IGSC 20%)
Product Code: IGSC 20%
INN or Proposed INN: Immune Globulin Subcutaneous (Human), 20%, Caprylate/Chromatography Purified
Grifols Therapeutics Inc.NULLNot RecruitingFemale: yes
Male: yes
60Phase 3France;Hungary;Czech Republic;Spain;Poland;Germany;United Kingdom
44EUCTR2014-003607-30-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
45EUCTR2016-003799-33-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
46EUCTR2014-003608-61-Outside-EU/EEA
(EUCTR)
05/01/2015Study of Subcutaneous Immune Globulin in Patients Requiring IgG Replacement Therapy (Japan Study)A Multicenter Study of Efficacy, Safety, Tolerability, and Pharmacokinetics of Immune Globulin Subcutaneous (Human) IgPro20 in Subjects With Primary Immunodeficiency Primary Immune Deficiency;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 BehringNULLNAFemale: yes
Male: yes
25Japan