Hizentra    (DrugBank: -)

4 diseases
告示番号疾患名(ページ内リンク)臨床試験数
14慢性炎症性脱髄性多発神経炎/多巣性運動ニューロパチー20
50皮膚筋炎/多発性筋炎5
51全身性強皮症4
65原発性免疫不全症候群8

14. 慢性炎症性脱髄性多発神経炎/多巣性運動ニューロパチー [臨床試験数:145,薬物数:139(DrugBank:23),標的遺伝子数:12,標的パスウェイ数:21
Searched query = "Chronic inflammatory demyelinating polyneuropathy", "Chronic inflammatory demyelinating poly (radiculo) neuropathy", "Multifocal motor neuropathy", "CIDP"
The queries were searched in Public_title, Scientific_title, and Condition. Export date: 03/15/2021. Trials are sorted by Date_enrollment from most recent to oldest in the table.
20 / 145 trials found
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1EUCTR2018-003592-34-DK02/08/201914/03/2019Subcutaneous versus intravenous administration of immunoglobulin in newly diagnosed patients with chronic inflammatory neuropathySubcutaneous immunoglobulin in de-novo CIDP(Randomized, parallel study of subcutaneous versus intravenous immunoglobulin in treatment-naïve patients with chronic inflammatory demyelinating polyneuropathy) - SIDEC Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)
MedDRA version: 21.1Level: PTClassification code 10064135Term: Polyneuropathy chronicSystem Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: Hizentra
Product Name: Hizentra
INN or Proposed INN: Human Immunoglobulin G
Other descriptive name: HUMAN IMMUNOGLOBULIN G
Trade Name: Privigen
Product Name: Privigen
INN or Proposed INN: Human Immunoglobulin G
Other descriptive name: HUMAN IMMUNOGLOBULIN G
Aarhus University HospitalNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
60Phase 4Denmark
2EUCTR2017-002024-24-DK08/09/201719/06/2017Systematic reduction in dosage of subcutanoeus immunoglobulin in patients with chronic inflammatory neuropathyRandomized, cohort study of standardized reduction of subcutaneous immunoglobulin treatment in patients with chronic inflammatory demyelinating polyneuropathy Chronic inflammatory demyelinating polyneuroapthy
MedDRA version: 20.0Level: LLTClassification code 10077384Term: Chronic inflammatory demyelinating polyneuropathySystem Organ Class: 100000014567;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: Gammanorm
Product Name: Gammanorm
INN or Proposed INN: Immunoglobulin
Other descriptive name: HUMAN IMMUNOGLOBULIN G
Trade Name: Hizentra
Product Name: Hizentra
INN or Proposed INN: Immunoglobulin
Other descriptive name: HUMAN IMMUNOGLOBULIN G
Trade Name: Subcuvia
Product Name: Subcuvia
INN or Proposed INN: Immunoglobulin
Other descriptive name: HUMAN IMMUNOGLOBULIN G
Aarhus Unversity HospitalNULLNot RecruitingFemale: yes
Male: yes
60Phase 4Denmark
3EUCTR2011-003448-28-PL07/07/201506/05/2015Chronic inflammatory demyelinating polyneuropathy (CIDP) and treatment with subcutaneous immunoglobulin (IgPro20)Randomized, multicenter, double-blind, placebo-controlled, parallel-group phase III study to investigate the efficacy, safety, and tolerability of 2 different doses of IgPro20 (subcutaneous immunoglobulin) for the treatment of chronic inflammatory demyelinating polyneuropathy (CIDP) – the PATH study - PATH Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)
MedDRA version: 19.0Level: PTClassification code 10061811Term: Demyelinating polyneuropathySystem Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: Hizentra®
Product Name: Hizentra®
Product Code: IgPro20
INN or Proposed INN: Human normal immunoglobulin (SCIg)
CSL Behring GmbHNULLNot RecruitingFemale: yes
Male: yes
350Phase 3United States;Estonia;Finland;Spain;Lithuania;Austria;Israel;United Kingdom;Italy;France;Czech Republic;Canada;Poland;Belgium;Australia;Netherlands;Germany;Japan
4EUCTR2011-003448-28-EE11/06/201514/05/2015Chronic inflammatory demyelinating polyneuropathy (CIDP) and treatment with subcutaneous immunoglobulin (IgPro20)Randomized, multicenter, double-blind, placebo-controlled, parallel-group phase III study to investigate the efficacy, safety, and tolerability of 2 different doses of IgPro20 (subcutaneous immunoglobulin) for the treatment of chronic inflammatory demyelinating polyneuropathy (CIDP) – the PATH study - PATH Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)
MedDRA version: 18.1Level: PTClassification code 10061811Term: Demyelinating polyneuropathySystem Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: Hizentra®
Product Name: Hizentra®
Product Code: IgPro20
INN or Proposed INN: Human normal immunoglobulin (SCIg)
CSL Behring GmbHNULLNot RecruitingFemale: yes
Male: yes
350Phase 3United States;Estonia;Finland;Spain;Lithuania;Austria;Israel;Italy;United Kingdom;Czech Republic;European Union;Canada;Poland;Belgium;Australia;Germany;Netherlands;Japan
5EUCTR2011-003448-28-LT09/06/201521/04/2015Chronic inflammatory demyelinating polyneuropathy (CIDP) and treatment with subcutaneous immunoglobulin (IgPro20)Randomized, multicenter, double-blind, placebo-controlled, parallel-group phase III study to investigate the efficacy, safety, and tolerability of 2 different doses of IgPro20 (subcutaneous immunoglobulin) for the treatment of chronic inflammatory demyelinating polyneuropathy (CIDP) – the PATH study - PATH Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)
MedDRA version: 18.0Level: PTClassification code 10061811Term: Demyelinating polyneuropathySystem Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: Hizentra®
Product Name: Hizentra®
Product Code: IgPro20
INN or Proposed INN: Human normal immunoglobulin (SCIg)
CSL Behring GmbHNULLNot RecruitingFemale: yes
Male: yes
350Phase 3United States;Estonia;Finland;Spain;Lithuania;Austria;Israel;Italy;United Kingdom;Czech Republic;European Union;Canada;Poland;Belgium;Australia;Germany;Netherlands;Japan
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
6EUCTR2013-004157-24-CZ12/03/201524/03/2014Extension study of maintenance treatment with subcutaneous immunoglobulin (IgPro20) for chronic inflammatory demyelinating polyneuropathy (CIDP)Multicenter, open-label extension study to investigate thelong-term safety and efficacy of IgPro20 in maintenancetreatment of chronic inflammatory demyelinatingpolyneuropathy (CIDP) in subjects completing studyIgPro20_3003 Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)
MedDRA version: 18.0Level: PTClassification code 10061811Term: Demyelinating polyneuropathySystem Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: Hizentra®
Product Name: Hizentra®
Product Code: IgPro20
INN or Proposed INN: Human normal immunoglobulin (SCIg)
Other descriptive name: Hizentra®
CSL Behring GmbHNULLNot RecruitingFemale: yes
Male: yes
80Phase 3United States;Czech Republic;European Union;Canada;Finland;Spain;Australia;Netherlands;Germany;Italy;Japan
7EUCTR2013-004157-24-NL02/12/201420/03/2014Extension study of maintenance treatment with subcutaneous immunoglobulin (IgPro20) for chronic inflammatory demyelinating polyneuropathy (CIDP)Multicenter, open-label extension study to investigate thelong-term safety and efficacy of IgPro20 in maintenancetreatment of chronic inflammatory demyelinatingpolyneuropathy (CIDP) in subjects completing studyIgPro20_3003 Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)
MedDRA version: 18.1Level: PTClassification code 10061811Term: Demyelinating polyneuropathySystem Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: Hizentra®
Product Name: Hizentra®
Product Code: IgPro20
INN or Proposed INN: Human normal immunoglobulin (SCIg)
Other descriptive name: Hizentra®
CSL Behring GmbHNULLNot RecruitingFemale: yes
Male: yes
80Phase 3United States;Czech Republic;European Union;Canada;Finland;Spain;Australia;Germany;Netherlands;Italy;Japan
8EUCTR2013-004157-24-IT01/10/201421/02/2014Extension study of maintenance treatment with subcutaneous immunoglobulin (IgPro20) for chronic inflammatory demyelinating polyneuropathy (CIDP)Multicenter, open-label extension study to investigate thelong-term safety and efficacy of IgPro20 in maintenancetreatment of chronic inflammatory demyelinatingpolyneuropathy (CIDP) in subjects completing studyIgPro20_3003 Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)
MedDRA version: 16.1Level: PTClassification code 10061811Term: Demyelinating polyneuropathySystem Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: Hizentra®
Product Name: Hizentra®
Product Code: IgPro20
INN or Proposed INN: Human normal immunoglobulin (SCIg)
Other descriptive name: Hizentra®
CSL Behring GmbHNULLNot RecruitingFemale: yes
Male: yes
70Phase 3United States;Czech Republic;European Union;Canada;Finland;Spain;Australia;Israel;Netherlands;Germany;Japan;Italy
9EUCTR2013-004157-24-DE05/06/201425/02/2014Extension study of maintenance treatment with subcutaneous immunoglobulin (IgPro20) for chronic inflammatory demyelinating polyneuropathy (CIDP)Multicenter, open-label extension study to investigate thelong-term safety and efficacy of IgPro20 in maintenancetreatment of chronic inflammatory demyelinatingpolyneuropathy (CIDP) in subjects completing studyIgPro20_3003 Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)
MedDRA version: 19.0Level: PTClassification code 10061811Term: Demyelinating polyneuropathySystem Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: Hizentra®
Product Name: Hizentra®
Product Code: IgPro20
INN or Proposed INN: Human normal immunoglobulin (SCIg)
Other descriptive name: Hizentra®
CSL Behring GmbHNULLNot RecruitingFemale: yes
Male: yes
80Phase 3United States;Czech Republic;European Union;Canada;Finland;Spain;Australia;Netherlands;Germany;Italy;Japan
10EUCTR2013-004157-24-ES23/04/201427/02/2014Extension study of maintenance treatment with subcutaneous immunoglobulin (IgPro20) for chronic inflammatory demyelinating polyneuropathy (CIDP)Multicenter, open-label extension study to investigate thelong-term safety and efficacy of IgPro20 in maintenancetreatment of chronic inflammatory demyelinatingpolyneuropathy (CIDP) in subjects completing studyIgPro20_3003 Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)
MedDRA version: 16.1Level: PTClassification code 10061811Term: Demyelinating polyneuropathySystem Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: Hizentra®
Product Name: Hizentra®
Product Code: IgPro20
INN or Proposed INN: Human normal immunoglobulin (SCIg)
Other descriptive name: Hizentra®
CSL Behring GmbHNULLNot RecruitingFemale: yes
Male: yes
70Phase 3United States;Czech Republic;European Union;Canada;Finland;Spain;Australia;Israel;Netherlands;Germany;Italy;Japan
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
11EUCTR2013-004157-24-FI04/04/201419/03/2014Extension study of maintenance treatment with subcutaneous immunoglobulin (IgPro20) for chronic inflammatory demyelinating polyneuropathy (CIDP)Multicenter, open-label extension study to investigate thelong-term safety and efficacy of IgPro20 in maintenancetreatment of chronic inflammatory demyelinatingpolyneuropathy (CIDP) in subjects completing studyIgPro20_3003 Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)
MedDRA version: 17.1Level: PTClassification code 10061811Term: Demyelinating polyneuropathySystem Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: Hizentra®
Product Name: Hizentra®
Product Code: IgPro20
INN or Proposed INN: Human normal immunoglobulin (SCIg)
Other descriptive name: Hizentra®
CSL Behring GmbHNULLNot RecruitingFemale: yes
Male: yes
40Phase 3United States;Czech Republic;European Union;Canada;Finland;Spain;Australia;Netherlands;Germany;Italy;Japan
12EUCTR2013-001428-20-DK06/06/201306/06/2013Study of the effect of subcutaneous administration of immunoglobulin in patients with newly diagnosed chronic inflammatory demyelinating polyradiculoneuropathyRandomized, single-blind crossover study of subcutaneous immunoglobulin in newly diagnosed patients with chronic inflammatory demyelinating polyradiculoneuropathy Chronic inflammatory demyelinating polyradiculoneuropathy (CIDP)
MedDRA version: 16.0Level: PTClassification code 10064135Term: Polyneuropathy chronicSystem Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: Hizentra
Product Name: Hizentra
INN or Proposed INN: Human normal immunoglobulin
Other descriptive name: HUMAN NORMAL IMMUNOGLOBULIN
Trade Name: Privigen
Product Name: Privigen
INN or Proposed INN: Human normal immunoglobulin
Other descriptive name: HUMAN NORMAL IMMUNOGLOBULIN
Aarhus University HospitalNULLNot RecruitingFemale: yes
Male: yes
Phase 2Denmark
13EUCTR2011-003448-28-BE27/09/201202/04/2012Chronic inflammatory demyelinating polyneuropathy (CIDP) and treatment with subcutaneous immunoglobulin (IgPro20)Randomized, multicenter, double-blind, placebo-controlled, parallel-group phase III study to investigate the efficacy, safety, and tolerability of 2 different doses of IgPro20 (subcutaneous immunoglobulin) for the treatment of chronic inflammatory demyelinating polyneuropathy (CIDP) – the PATH study - PATH Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)
MedDRA version: 18.1Level: PTClassification code 10061811Term: Demyelinating polyneuropathySystem Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: Hizentra®
Product Name: Hizentra®
Product Code: IgPro20
INN or Proposed INN: Human normal immunoglobulin (SCIg)
CSL Behring GmbHNULLNot RecruitingFemale: yes
Male: yes
350Phase 3United States;Estonia;Finland;Spain;Lithuania;Austria;Israel;Italy;United Kingdom;Czech Republic;European Union;Canada;Poland;Belgium;Australia;Germany;Netherlands;Japan
14EUCTR2011-003448-28-IT23/08/201229/03/2012Chronic inflammatory demyelinating polyneuropathy (CIDP) and treatment with subcutaneous immunoglobulin (IgPro20)Randomized, multicenter, double-blind, placebo-controlled, parallelgroup phase III study to investigate the efficacy, safety, and tolerability of 2 different doses of IgPro20 (subcutaneous immunoglobulin) for the treatment of chronic inflammatory demyelinating polyneuropathy (CIDP) – the PATH study - PATH Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)
MedDRA version: 14.1Level: PTClassification code 10061811Term: Demyelinating polyneuropathySystem Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: Hizentra®
INN or Proposed INN: HUMAN NORMAL IMMUNOGLOBULIN
CSL BEHRING GMBHNULLNot RecruitingFemale: yes
Male: yes
250Phase 3United States;Estonia;Finland;Spain;Lithuania;Austria;United Kingdom;Italy;Switzerland;Czech Republic;Canada;Argentina;Poland;Belgium;Australia;Germany;Netherlands;Korea, Republic of
15EUCTR2011-003448-28-AT18/05/201216/03/2012Chronic inflammatory demyelinating polyneuropathy (CIDP) and treatment with subcutaneous immunoglobulin (IgPro20)Randomized, multicenter, double-blind, placebo-controlled, parallel-group phase III study to investigate the efficacy, safety, and tolerability of 2 different doses of IgPro20 (subcutaneous immunoglobulin) for the treatment of chronic inflammatory demyelinating polyneuropathy (CIDP) – the PATH study - PATH Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)
MedDRA version: 14.1Level: PTClassification code 10061811Term: Demyelinating polyneuropathySystem Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: Hizentra®
Product Name: Hizentra®
Product Code: IgPro20
INN or Proposed INN: Human normal immunoglobulin (SCIg)
CSL Behring GmbHNULLNot RecruitingFemale: yes
Male: yes
250Phase 3United States;Finland;Spain;Austria;Israel;Italy;Switzerland;United Kingdom;France;Hungary;Czech Republic;Canada;Argentina;Belgium;Australia;Netherlands;Germany;Korea, Republic of
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
16EUCTR2011-003448-28-NL11/05/201214/03/2012Chronic inflammatory demyelinating polyneuropathy (CIDP) and treatment with subcutaneous immunoglobulin (IgPro20)Randomized, multicenter, double-blind, placebo-controlled, parallel-group phase III study to investigate the efficacy, safety, and tolerability of 2 different doses of IgPro20 (subcutaneous immunoglobulin) for the treatment of chronic inflammatory demyelinating polyneuropathy (CIDP) – the PATH study - PATH Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)
MedDRA version: 17.1Level: PTClassification code 10061811Term: Demyelinating polyneuropathySystem Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: Hizentra®
Product Name: Hizentra®
Product Code: IgPro20
INN or Proposed INN: Human normal immunoglobulin (SCIg)
CSL Behring GmbHNULLNot RecruitingFemale: yes
Male: yes
350Phase 3United States;Estonia;Finland;Spain;Lithuania;Austria;Israel;Italy;United Kingdom;Czech Republic;European Union;Canada;Poland;Belgium;Australia;Netherlands;Germany;Japan
17EUCTR2011-003448-28-CZ09/05/201223/02/2012Chronic inflammatory demyelinating polyneuropathy (CIDP) and treatment with subcutaneous immunoglobulin (IgPro20)Randomized, multicenter, double-blind, placebo-controlled, parallel-group phase III study to investigate the efficacy, safety, and tolerability of 2 different doses of IgPro20 (subcutaneous immunoglobulin) for the treatment of chronic inflammatory demyelinating polyneuropathy (CIDP) – the PATH study - PATH Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)
MedDRA version: 18.1Level: PTClassification code 10061811Term: Demyelinating polyneuropathySystem Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: Hizentra®
Product Name: Hizentra®
Product Code: IgPro20
INN or Proposed INN: Human normal immunoglobulin (SCIg)
CSL Behring GmbHNULLNot RecruitingFemale: yes
Male: yes
350Phase 3United States;Estonia;Finland;Spain;Lithuania;Austria;Israel;Italy;United Kingdom;Czech Republic;European Union;Canada;Poland;Belgium;Australia;Germany;Netherlands;Japan
18EUCTR2011-003448-28-ES24/04/201229/02/2012Chronic inflammatory demyelinating polyneuropathy (CIDP) and treatment with subcutaneous immunoglobulin (IgPro20)Randomized, multicenter, double-blind, placebo-controlled, parallel-group phase III study to investigate the efficacy, safety, and tolerability of 2 different doses of IgPro20 (subcutaneous immunoglobulin) for the treatment of chronic inflammatory demyelinating polyneuropathy (CIDP)-the PATH study - PATH Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)
MedDRA version: 14.1Level: PTClassification code 10061811Term: Demyelinating polyneuropathySystem Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: Hizentra®
Product Name: Hizentra®
Product Code: IgPro20
INN or Proposed INN: Human normal immunoglobulin (SCIg)
CSL Behring GmbHNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
250Phase 3Hungary;Germany;Switzerland;Netherlands;France;Italy;Austria;Australia;Finland;United Kingdom;Czech Republic;Canada;Argentina;Belgium;Korea, Republic of;Spain;United States
19EUCTR2011-003448-28-DE20/04/201231/01/2012Chronic inflammatory demyelinating polyneuropathy (CIDP) and treatment with subcutaneous immunoglobulin (IgPro20)Randomized, multicenter, double-blind, placebo-controlled, parallel-group phase III study to investigate the efficacy, safety, and tolerability of 2 different doses of IgPro20 (subcutaneous immunoglobulin) for the treatment of chronic inflammatory demyelinating polyneuropathy (CIDP) – the PATH study - PATH Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)
MedDRA version: 19.0Level: PTClassification code 10061811Term: Demyelinating polyneuropathySystem Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: Hizentra®
Product Name: Hizentra®
Product Code: IgPro20
INN or Proposed INN: Human normal immunoglobulin (SCIg)
CSL Behring GmbHNULLNot RecruitingFemale: yes
Male: yes
350Phase 3United States;Estonia;Finland;Spain;Lithuania;Austria;Israel;United Kingdom;Italy;France;Czech Republic;Canada;Poland;Belgium;Australia;Netherlands;Germany;Japan
20EUCTR2011-003448-28-FI05/04/201205/03/2012Chronic inflammatory demyelinating polyneuropathy (CIDP) and treatment with subcutaneous immunoglobulin (IgPro20)Randomized, multicenter, double-blind, placebo-controlled, parallel-group phase III study to investigate the efficacy, safety, and tolerability of 2 different doses of IgPro20 (subcutaneous immunoglobulin) for the treatment of chronic inflammatory demyelinating polyneuropathy (CIDP) – the PATH study - PATH Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)
MedDRA version: 18.1Level: PTClassification code 10061811Term: Demyelinating polyneuropathySystem Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: Hizentra®
Product Name: Hizentra®
Product Code: IgPro20
INN or Proposed INN: Human normal immunoglobulin (SCIg)
CSL Behring GmbHNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
350Phase 3Japan;United States;Estonia;Finland;Spain;Lithuania;Austria;Israel;Italy;United Kingdom;Czech Republic;European Union;Canada;Poland;Belgium;Australia;Germany;Netherlands

50. 皮膚筋炎/多発性筋炎 [臨床試験数:157,薬物数:207(DrugBank:76),標的遺伝子数:47,標的パスウェイ数:142
Searched query = "Dermatomyositis", "Polymyositis"
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.
5 / 157 trials found
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1EUCTR2018-003171-35-DE20/01/202018/09/2019A study to evaluate the efficacy, safety, and pharmacokinetics of IgPro20 in adults with dermatomyositis (DM)A Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of IgPro20 (Subcutaneous Immunoglobulin, Hizentra®) in Adults with Dermatomyositis (DM) – The RECLAIIM Study Dermatomyositis
MedDRA version: 20.0Level: LLTClassification code 10001403Term: Adult dermatomyositisSystem Organ Class: 100000004858;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]
Trade Name: Hizentra
Product Name: human immunoglobulin G
Product Code: IgPro20
INN or Proposed INN: human immunoglobulin G
Other descriptive name: Hizentra
CSL Behring LLCNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
126Phase 3United States;Spain;Ukraine;Russian Federation;Switzerland;United Kingdom;France;European Union;Mexico;Argentina;Australia;Germany;Japan
2EUCTR2018-003171-35-ES14/11/201929/11/2019A study to evaluate the efficacy, safety, and pharmacokinetics of IgPro20 in adults with dermatomyositis (DM)A Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of IgPro20 (Subcutaneous Immunoglobulin, Hizentra®) in Adults with Dermatomyositis (DM) Dermatomyositis
MedDRA version: 20.0 Level: LLT Classification code 10001403 Term: Adult dermatomyositis System Organ Class: 100000004858 ;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]
CSL Behring LLCNULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
126 Human pharmacology (Phase 1): no Therapeut1c exploratory (Phase 2): no Therapeut1c conf1rmatory - (Phase 3): yes Therapeut1c use (Phase 4): noUnited States;Spain;Ukraine;Russian Federation;Switzerland;United Kingdom;France;European Union;Mexico;Canada;Argentina;Australia;Germany;Japan
3NCT04044690October 21, 20191/8/2019A Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of IgPro20 in Adults With Dermatomyositis (DM)A Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of IgPro20 (Subcutaneous Immunoglobulin, Hizentra®) in Adults With Dermatomyositis (DM) - The RECLAIIM StudyDermatomyositisDrug: human immunoglobulin G;Drug: PlaceboCSL BehringNULLRecruiting18 YearsN/AAll126Phase 3United States;Germany;Italy;Japan;Russian Federation;Switzerland;Ukraine
4EUCTR2018-003171-35-FR24/09/201911/09/2019A study to evaluate the efficacy, safety, and pharmacokinetics of IgPro20 in adults with dermatomyositis (DM)A Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of IgPro20 (Subcutaneous Immunoglobulin, Hizentra®) in Adults with Dermatomyositis (DM) Dermatomyositis
MedDRA version: 20.0 Level: LLT Classification code 10001403 Term: Adult dermatomyositis System Organ Class: 100000004858 ;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]
CSL Behring LLCNULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
126 Human pharmacology (Phase 1): no Therapeut1c exploratory (Phase 2): no Therapeut1c conf1rmatory - (Phase 3): yes Therapeut1c use (Phase 4): noUnited States;France;Mexico;European Union;Canada;Argentina;Ukraine;Australia;Russian Federation;Japan;United Kingdom;Switzerland
5NCT02271165November 201415/10/2014Subcutaneous Immunoglobulin (Hizentra) in Patients With Dermatomyositis: A Proof of Concept StudyDermatomyositisDrug: Immunoglobulin (Hizentra)Thomas Jefferson UniversityNULLTerminated18 YearsN/AAll2Early Phase 1United States

51. 全身性強皮症 [臨床試験数:466,薬物数:536(DrugBank:142),標的遺伝子数:110,標的パスウェイ数:210
Searched query = "Scleroderma", "Systemic sclerosis", "SSc", "dcSSc", "lcSSc"
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.
4 / 466 trials found
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
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PhaseCountries
1NCT04137224September 19, 201921/10/2019Safety and Pharmacokinetics of IgPro20 and IgPro10 in Adults With Systemic Sclerosis (SSc)A Multicenter, Randomized, Open-label, Crossover, Phase 2 Study to Evaluate the Safety and Pharmacokinetics of IgPro20 (Subcutaneous Immunoglobulin, Hizentra®) and IgPro10 (Intravenous Immunoglobulin, Privigen®) in Adults With Systemic Sclerosis (SSc)Diffuse Cutaneous Systemic SclerosisBiological: IgPro20;Biological: IgPro10CSL BehringNULLRecruiting18 YearsN/AAll26Phase 2Australia;France;Germany;Italy;Poland;United Kingdom
2EUCTR2018-003149-41-DE16/07/201920/03/2019Safety and Pharmacokinetics of IgPro20 and IgPro10 in Adults with Systemic Sclerosis (SSc).A Multicenter, Randomized, Open-label, Crossover, Phase 2 Study to Evaluate the Safety and Pharmacokinetics of IgPro20 (subcutaneous immunoglobulin, Hizentra®) and IgPro10 (intravenous immunoglobulin, Privigen®) in Adults with Systemic Sclerosis (SSc). - n/a Safety and Pharmacokinetics in subjects with diffuse cutaneous systemic sclerosis
MedDRA version: 21.0Level: LLTClassification code 10012977Term: Diffuse systemic sclerosisSystem Organ Class: 100000004859;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Trade Name: Hizentra
Product Name: Human normal immunoglobulin for subcutaneous administration
Product Code: IgPro20
INN or Proposed INN: Human normal immunoglobulin
Other descriptive name: HUMAN NORMAL IMMUNOGLOBULIN
Trade Name: Privigen
Product Name: Human normal immunoglobulin for intravenous administration
Product Code: IgPro10
INN or Proposed INN: Human normal immunoglobulin
Other descriptive name: HUMAN NORMAL IMMUNOGLOBULIN
CSL Behring GmbHNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
26Phase 2France;Poland;Australia;Germany;United Kingdom;Italy
3EUCTR2018-003149-41-FR24/05/201927/03/2019Safety and Pharmacokinetics of IgPro20 and IgPro10 in Adults with Systemic Sclerosis (SSc).A Multicenter, Randomized, Open-label, Crossover, Phase 2 Study to Evaluate the Safety and Pharmacokinetics of IgPro20 (subcutaneous immunoglobulin, Hizentra®) and IgPro10 (intravenous immunoglobulin, Privigen®) in Adults with Systemic Sclerosis (SSc). - n/a Safety and Pharmacokinetics in subjects with diffuse cutaneous systemic sclerosis
MedDRA version: 20.0 Level: LLT Classification code 10012977 Term: Diffuse systemic sclerosis System Organ Class: 100000004859 ;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
CSL Behring GmbHNULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
26 Human pharmacology (Phase 1): no Therapeut1c exploratory (Phase 2): yes Therapeut1c conf1rmatory - (Phase 3): no Therapeut1c use (Phase 4): noFrance;Poland;Australia;Germany;Italy;United Kingdom
4EUCTR2018-003149-41-GB15/05/201930/07/2019Safety and Pharmacokinetics of IgPro20 and IgPro10 in Adults with Systemic Sclerosis (SSc).A Multicenter, Randomized, Open-label, Crossover, Phase 2 Study to Evaluate the Safety and Pharmacokinetics of IgPro20 (subcutaneous immunoglobulin, Hizentra®) and IgPro10 (intravenous immunoglobulin, Privigen®) in Adults with Systemic Sclerosis (SSc). - n/a Safety and Pharmacokinetics in subjects with diffuse cutaneous systemic sclerosis
MedDRA version: 21.0Level: LLTClassification code 10012977Term: Diffuse systemic sclerosisSystem Organ Class: 100000004859;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Trade Name: Hizentra
Product Name: Human normal immunoglobulin for subcutaneous administration
Product Code: IgPro20
INN or Proposed INN: Human normal immunoglobulin
Other descriptive name: HUMAN NORMAL IMMUNOGLOBULIN
Trade Name: Privigen
Product Name: Human normal immunoglobulin for intravenous administration
Product Code: IgPro10
INN or Proposed INN: Human normal immunoglobulin
Other descriptive name: HUMAN NORMAL IMMUNOGLOBULIN
CSL Behring GmbHNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
26Phase 2France;Poland;Australia;Germany;Italy;United Kingdom

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.
8 / 413 trials found
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1NCT03033745February 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
2NCT01354587October 201018/3/2011Evaluation of Efficacy and Tolerability of Hizentra®Evaluation of Efficacy and Tolerability of Hizentra® in Subjects Transitioning From Vivaglobin® (16% SCIG Product) to Hizentra® (20% SCIG Product)Primary Immunodeficiency DisordersDrug: HizentraUniversity of South FloridaNULLRecruiting1 Year75 YearsBoth50N/AUnited States
3EUCTR2016-003799-33-Outside-EU/EEA30/01/2017Safety 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: 19.1Level: PTClassification code 10064859Term: Primary immunodeficiency syndromeSystem Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Trade Name: 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
4EUCTR2014-003607-30-Outside-EU/EEA26/02/2015Study 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: 17.1Level: PTClassification code 10064859Term: Primary immunodeficiency syndromeSystem Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Trade Name: 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
5EUCTR2014-003409-13-Outside-EU/EEA05/01/2015Multicenter 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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
6EUCTR2014-003609-14-Outside-EU/EEA05/01/2015Follow-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
7EUCTR2014-003605-15-Outside-EU/EEA26/02/2015Extension 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: 17.1Level: PTClassification code 10064859Term: Primary immunodeficiency syndromeSystem Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Trade Name: Hizentra®
INN or Proposed INN: Human Normal Immunoglobulin
Other descriptive name: HUMAN NORMAL IMMUNOGLOBULIN
CSL Behring AGNULLNAFemale: yes
Male: yes
21United States
8EUCTR2014-003608-61-Outside-EU/EEA05/01/2015Study 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