65. 原発性免疫不全症候群 [臨床試験数:413,薬物数:581(DrugBank:97),標的遺伝子数:68,標的パスウェイ数:202

Searched query = "Primary immunodeficiency", "X-SCID", "Reticular dysgenesis", "Adenosine deaminase deficiency", "Omenn syndrome", "Purine nucleoside phosphorylase deficiency", "CD8 deficiency", "ZAP-70 deficiency", "MHC class I deficiency", "MHC class II deficiency", "Combined immunodeficiency", "Wiskott-Aldrich syndrome", "Telangiectasia ataxia", "Nijmegen breakage syndrome", "Bloom syndrome", "Immunodeficiency, centromere region instability, facial anomalies syndrome", "ICF syndrome", "PMS2 deficiency", "Radiosensitivity, immunodeficiency, dysmorphic features, and learning difficulties syndrome", "RIDDLE syndrome", "Schimke syndrome", "Netherton syndrome", "Thymic hypoplasia", "DiGeorge syndrome", "22q11.2 deletion syndrome", "Hyper-IgE syndrome", "Hepatic venoocclusive immunodeficiency", "Immunodeficiency with central hepatic vein atresia", "Dyskeratosis congenita", "X-linked agammaglobulinaemia", "Common variable immunodeficiency", "Hyper-IgM syndrome", "Isolated IgG subclass deficiency", "Selective IgA deficiency", "Specific antibody production deficiency", "Infant transient hypogammaglobulinemia", "Chédiak-Higashi syndrome", "Chediak-Higashi syndrome", "X-linked lymphoproliferative syndrome", "SAP deficiency", "SH2D1A/SLAM-associated protein deficiency", "XIAP deficiency", "X-linked inhibitor of apoptosis deficiency", "Autoimmune lymphoproliferative syndrome", "ALPS", "Familial hemophagocytic syndrome", "Perforin deficiency", "Munc13-4 deficiency", "Syntaxin 11 deficiency", "Munc18-2 deficiency", "Autoimmune polyendocrinopathy-candidiasis-ectodermal dystrophy", "APECED", "Immune dysregulation, polyendocrinopathy, enteropathy, X-linked syndrome", "IPEX syndrome", "CD25 deficiency", "ITCH deficiency", "Primary phagocytic dysfunction", "Severe congenital neutropenia", "Cyclic neutropenia", "Hermanskyi-Pudlak syndrome type 2", "Hermanskyi-Pudlak syndrome 2", "Griscelli syndrome type 2", "Griscelli syndrome 2", "p14 deficiency", "Warts, hypogammaglobulinemia, infections, myelokathexis syndrome", "WHIM syndrome", "Glycogen storage disease type Ib", "Leukocyte adhesion deficiency", "Shwachman-Diamond syndrome", "Chronic granulomatous disease", "Myeloperoxidase deficiency", "Mendelian susceptibility to mycobacterial disease", "MSMD", "Anhidrotic ectodermal dysplasia with immunodeficiency", "EDA-ID", "Interleukin-1 receptor-associated kinase-4 deficiency", "IRAK4 deficiency", "IMyD88 deficiency", "Chronic mucocutaneous candidiasis", "Epidermodysplasia verruciformis", "Herpes simplex encephalitis", "Caspase recruitment domain family member 9 deficiency", "CARD9 deficiency", "Trypanosomiasis", "Congenital complement deficiency", "C1q deficiency", "CC1r deficiency", "CC1s deficiency", "CC2 deficiency", "CC3 deficiency", "CC4 deficiency", "CC5 deficiency", "CC6 deficiency", "CC7 deficiency", "CC8 deficiency", "CC9 deficiency", "Factor D deficiency", "Properdin deficiency", "Factor I deficiency", "Factor H deficiency", "MASP1 deficiency", "3MC syndrome", "Mannose-binding protein-associated serine protease 2 deficiency", "MASP2 deficiency", "FCN3", "Hereditary angioedema type 1", "Hereditary angioedema type I", "C1 inhibitor deficiency type 1", "C1 inhibitor deficiency type I", "Hereditary angioedema type 2", "Hereditary angioedema type II", "C1 inhibitor deficiency type 2", "C1 inhibitor deficiency type II", "Hereditary angioedema type 3", "Hereditary angioedema type III", "C1 inhibitor deficiency type 3", "C1 inhibitor deficiency type III"
The queries were searched in Public_title, Scientific_title, and Condition. Export date: 03/15/2021. Trials are sorted by Date_enrollment from most recent to oldest in the table.

Search in Page e.g. "Phase 3", "Not recruiting", "Japan"
26 trials found
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1NCT03033745
(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
2NCT01461018
(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
3NCT01458171
(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
4NCT01199705
(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
5EUCTR2008-000830-30-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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
6EUCTR2008-000830-30-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]
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
7EUCTR2008-000830-30-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 AGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
36United Kingdom;Germany;France;Spain;Sweden
8EUCTR2008-000830-30-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
9EUCTR2006-006745-13-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 BehringNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
43United Kingdom;Germany;France;Spain;Italy;Poland;Sweden
10NCT00751621
(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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
11EUCTR2008-000830-30-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
12NCT00719680
(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
13EUCTR2006-006745-13-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
14NCT00542997
(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
15EUCTR2006-006745-13-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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
16EUCTR2006-006745-13-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 AGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
36United Kingdom;Germany;France;Spain;Italy;Poland;Sweden
17EUCTR2006-006745-13-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
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
18EUCTR2006-006745-13-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
19EUCTR2006-006745-13-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 AGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
36United Kingdom;Germany;France;Spain;Italy;Poland;Sweden
20NCT00419341
(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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
21EUCTR2016-003799-33-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
22EUCTR2014-003607-30-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
23EUCTR2014-003609-14-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
24EUCTR2014-003409-13-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
25EUCTR2014-003605-15-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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
26EUCTR2014-003608-61-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