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.

Search in Page e.g. "Phase 3", "Not recruiting", "Japan"
45 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
3EUCTR2013-005558-31-DE10/08/201608/07/2016Exstension of the international study on efficacy and safety of I10E in CIDP patientsInternational, multicentre, efficacy and safety study of I10E in themaintenance treatment of patients with Chronic InflammatoryDemyelinating Polyradiculoneuropathy: Extension of PRISM studyI10E-1302 - PRISM 2 Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP)
MedDRA version: 19.0Level: PTClassification code 10057645Term: Chronic inflammatory demyelinating polyradiculoneuropathySystem Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: IQYMUNE
Product Name: Human normal 10% immunoglobulin for intravenous administrationn
Product Code: I10
INN or Proposed INN: HUMAN NORMAL IMMUNOGLOBULIN (IV)
Other descriptive name: HUMAN NORMAL IMMUNOGLOBULIN (IV)
LFB BIOTECHNOLOGIESNULLNot RecruitingFemale: yes
Male: yes
30Phase 3France;Poland;Spain;Turkey;Tunisia;Germany;Italy;United Kingdom
4EUCTR2013-005557-73-DE10/08/201608/07/2016An international study on efficacy and safety of I10E in CIDP patientsAn international, multicentre, efficacy and safety study of I10E ininitial and maintenance treatment of patients with ChronicInflammatory Demyelinating Polyradiculoneuropathy - PRISM Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP)
MedDRA version: 19.0Level: PTClassification code 10057645Term: Chronic inflammatory demyelinating polyradiculoneuropathySystem Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: IQYMUNE
Product Name: human normal immunoglobulin for intravenous administration
Product Code: I10
INN or Proposed INN: HUMAN NORMAL IMMUNOGLOBULIN (IV)
Other descriptive name: HUMAN NORMAL IMMUNOGLOBULIN (IV)
LFB BIOTECHNOLOGIESNULLNot RecruitingFemale: yes
Male: yes
42Phase 3France;Poland;Spain;Turkey;Tunisia;Germany;Italy;United Kingdom
5EUCTR2015-000828-28-NL26/07/201630/11/2015Immunoglobulins given under the skin to treat patients with multifocal motor neuropathy (MMN). To increase the amount of immunoglobulins, an enzyme is added that will temporarily create more space under the skin. This space is filled with immunoglobulins. By this way less infusions should be needed.Titlle: Subcutaneous immunoglobulins with rHuPH20 in multifocal motor neuropathy (MMN) It is an interventional cross-over study where the use of the combination of subcutaneous immunoglobulins together with the enzyme hyaluronidase (rHuPH20) is compared with the current gold standard intravenous immunoglobulins (IVIg). Non-inferiority and tolerability are studied in 20 MMN patients. The reason to add rHuPH20 is to increase volumes per infusion and in this way contribute to reduced frequency of infusions. - Hymne Non-inferiority and safety/tolerance of Hyqvia compared to IVIg in 20 MMN patients with at least one conduction block on EMG and stable on IVIg.;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]Trade Name: Hyqvia
Product Name: Hyqvia
UMC UtrechtNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
Phase 3Netherlands
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
6EUCTR2015-003453-18-DK25/11/201523/09/2015Study of the effect and safety of a new immunoglobulin preparation (HyQvia) for subcutaneous usage in patients with Multifocal Motor NeuropathyA Randomized, Single-blinded, Cross-over Study investigating the Non-inferiority of Efficacy and Safety of HyQvia in comparison with Conventional Subcutaneous Ig Therapy in Multifocal Motor Neuropathy Multifocal Motor Neuropathy (MMN)
MedDRA version: 18.1Level: PTClassification code 10064135Term: Polyneuropathy chronicSystem Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: HyQvia
Product Name: HyQvia
INN or Proposed INN: Human normal immunoglobulin
Other descriptive name: HUMAN NORMAL IMMUNOGLOBULIN
Trade Name: Subcuvia
Product Name: Subcuvia
INN or Proposed INN: Human normal immunoglobulin
Other descriptive name: HUMAN NORMAL IMMUNOGLOBULIN
RigshospitaletNULLNot RecruitingFemale: yes
Male: yes
20Phase 2Denmark
7EUCTR2013-005558-31-FR23/07/201526/06/2015Extension of the international study on efficacy and safety of I10E in CIDP patientsInternational, multicentre, efficacy and safety study of I10E in themaintenance treatment of patients with Chronic InflammatoryDemyelinating Polyradiculoneuropathy: Extension of PRISM studyI10E-1302 - PRISM 2 Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP)
MedDRA version: 18.0Level: PTClassification code 10057645Term: Chronic inflammatory demyelinating polyradiculoneuropathySystem Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Human normal 10% immunoglobulin for intravenous administrationn
Product Code: I10E
INN or Proposed INN: HUMAN NORMAL IMMUNOGLOBULIN (IV)
Other descriptive name: HUMAN NORMAL IMMUNOGLOBULIN (IV)
LFB BIOTECHNOLOGIESNULLNot RecruitingFemale: yes
Male: yes
30Phase 3France;Morocco;Mexico;Spain;Turkey;Germany;Tunisia;Italy;United Kingdom
8EUCTR2011-003448-28-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
9EUCTR2011-003448-28-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
10EUCTR2011-003448-28-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
11EUCTR2012-001995-12-IT19/05/201513/03/2013A European, randomised, double-blind, active comparator-controlled, cross-over, efficacy and safety study of a new 10% ready-to-use liquid human intravenous immunoglobulin (I10E) versus Kiovig® in patients with Multifocal Motor NeuropathyA European, randomised, double-blind, active comparator-controlled, cross-over, efficacy and safety study of a new 10% ready-to-use liquid human intravenous immunoglobulin (I10E) versus Kiovig® in patients with Multifocal Motor Neuropathy Multifocal motor neuropathy (MMN)
MedDRA version: 15.1Level: PTClassification code 10065579Term: Multifocal motor neuropathySystem Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: KIOVIG
Product Name: KIOVIG
INN or Proposed INN: HUMAN NORMAL IMMUNOGLOBULIN
Other descriptive name: HUMAN NORMAL IMMUNOGLOBULIN (IV)
Product Name: human normal immunoglobulin for intravenous administration
Product Code: I10E
INN or Proposed INN: HUMAN NORMAL IMMUNOGLOBULIN
Other descriptive name: HUMAN NORMAL IMMUNOGLOBULIN (IV)
LFB BIOTECHNOLOGIESNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
20Phase 3France;Spain;United Kingdom;Italy
12EUCTR2013-004157-24-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
13NCT02414490March 201513/3/2015IVIg Treatment-Related Fluctuations in CIDP Patients Using Daily Grip Strength MeasurementsIntravenous Immunoglobulin (IVIg) Treatment-Related Fluctuations in Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) Patients Using Daily Grip Strength Measurements (GRIPPER)Chronic Inflammatory Demyelinating PolyneuropathyDrug: Intravenous ImmunoglobulinUniversity of MinnesotaBriovaRx Infusion Services;CSL BehringCompleted18 Years85 YearsAll30United States
14EUCTR2013-005558-31-ES18/02/201516/12/2014Exstension of the international study on efficacy and safety of I10E in CIDP patientsInternational, multicentre, efficacy and safety study of I10E in themaintenance treatment of patients with Chronic InflammatoryDemyelinating Polyradiculoneuropathy: Extension of PRISM studyI10E-1302 - PRISM 2 Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP)
MedDRA version: 17.1Level: PTClassification code 10057645Term: Chronic inflammatory demyelinating polyradiculoneuropathySystem Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Human normal 10% immunoglobulin for intravenous administrationn
Product Code: I10E
INN or Proposed INN: HUMAN NORMAL IMMUNOGLOBULIN (IV)
Other descriptive name: HUMAN NORMAL IMMUNOGLOBULIN (IV)
LFB BIOTECHNOLOGIESNULLNot RecruitingFemale: yes
Male: yes
30Phase 3France;Morocco;Mexico;Spain;Turkey;Germany;Tunisia;Italy;United Kingdom
15NCT02372149February 201512/2/2015IVIg for Demyelination in Diabetes MellitusTreatment With Gamunex 10% Intravenous Immunoglobulin (IVIg) for Patients With Demyelination and Diabetes Mellitus: A Blinded, Placebo-Controlled Crossover Pilot StudyPeripheral Neuropathy;Diabetes Mellitus;Chronic Inflammatory Demyelinating PolyneuropathyDrug: 10% intravenous immunoglobulin (IVIg);Drug: 0.9% sodium chlorideUniversity of TorontoUniversity Health Network, TorontoRecruiting18 YearsN/ABoth25Phase 4Canada
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
16EUCTR2013-005557-73-ES03/12/201427/08/2014An international study on efficacy and safety of I10E in CIDP patientsAn international, multicentre, efficacy and safety study of I10E ininitial and maintenance treatment of patients with ChronicInflammatory Demyelinating Polyradiculoneuropathy - PRISM Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP)
MedDRA version: 17.0Level: PTClassification code 10057645Term: Chronic inflammatory demyelinating polyradiculoneuropathySystem Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: human normal immunoglobulin for intravenous administration
Product Code: I10E
INN or Proposed INN: HUMAN NORMAL IMMUNOGLOBULIN (IV)
Other descriptive name: HUMAN NORMAL IMMUNOGLOBULIN (IV)
LFB BIOTECHNOLOGIESNULLNot RecruitingFemale: yes
Male: yes
42Phase 3France;Morocco;Mexico;Spain;Turkey;Germany;Tunisia;Italy;United Kingdom
17EUCTR2013-004157-24-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
18EUCTR2013-004157-24-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
19EUCTR2013-005557-73-IT30/09/201427/08/2014An international study on efficacy and safety of I10E in CIDP patientsAn international, multicentre, efficacy and safety study of I10E ininitial and maintenance treatment of patients with ChronicInflammatory Demyelinating Polyradiculoneuropathy - PRISM Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP)
MedDRA version: 17.0Level: PTClassification code 10057645Term: Chronic inflammatory demyelinating polyradiculoneuropathySystem Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: human normal immunoglobulin for intravenous administration
Product Code: I10E
INN or Proposed INN: HUMAN NORMAL IMMUNOGLOBULIN (IV)
Other descriptive name: HUMAN NORMAL IMMUNOGLOBULIN (IV)
LFB BIOTECHNOLOGIESNULLNot RecruitingFemale: yes
Male: yes
42Phase 3France;Morocco;Mexico;Spain;Turkey;Germany;Tunisia;United Kingdom;Italy
20EUCTR2013-005557-73-FR24/09/201426/06/2015An international study on efficacy and safety of I10E in CIDP patientsAn international, multicentre, efficacy and safety study of I10E ininitial and maintenance treatment of patients with ChronicInflammatory Demyelinating Polyradiculoneuropathy - PRISM Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP)
MedDRA version: 18.0Level: PTClassification code 10057645Term: Chronic inflammatory demyelinating polyradiculoneuropathySystem Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: human normal immunoglobulin for intravenous administration
Product Code: I10E
INN or Proposed INN: HUMAN NORMAL IMMUNOGLOBULIN (IV)
Other descriptive name: HUMAN NORMAL IMMUNOGLOBULIN (IV)
LFB BIOTECHNOLOGIESNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
42France;Morocco;Mexico;Spain;Turkey;Tunisia;Italy;United Kingdom
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
21JPRN-JapicCTI-14247204/8/201413/03/2014Phase 3 study of GGS in multifocal motor neuropathy (MMN)Open-label, uncontrolled, before-and-after study of GGS in multifocal motor neuropathy (MMN) (Phase 3 study) Multifocal motor neuropathy (MMN)Intervention name : Freeze-Dried Sulfonated Human Normal Immunoglobulin (GGS)
INN of the intervention : -
Dosage And administration of the intervention : Intravenous drip infusion
Control intervention name : -
INN of the control intervention : -
Dosage And administration of the control intervention : -
Teijin Pharma LimitedNULLcomplete2074BOTH5Phase 3Japan
22EUCTR2013-004157-24-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
23EUCTR2013-004157-24-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
24EUCTR2013-004157-24-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
25JPRN-JapicCTI-14247110/3/201413/03/2014Phase 3 study of GGS in chronic inflammatory demyelinating polyneuropathy (CIDP)Open-label, uncontrolled, before-and-after study of GGS in chronic inflammatory demyelinating polyneuropathy (CIDP) (Phase 3 study) Chronic inflammatory demyelinating polyneuropathy(CIDP)Intervention name : Freeze-Dried Sulfonated Human Normal Immunoglobulin (GGS)
INN of the intervention : -
Dosage And administration of the intervention : Intravenous drip infusion
Control intervention name : -
INN of the control intervention : -
Dosage And administration of the control intervention : -
Teijin Pharma LimitedNULLcomplete2074BOTH30Phase 3Japan
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
26EUCTR2013-004988-32-NL22/01/201420/01/2014Pharmacokinetics of IVIg treatment in patients with CIDPRotterdam Observational Study in CIDP of Pharmacokinetics of Intravenous ?-globulin - ROCKY-1 Chronic Inflammatory Demyelinating Polyneuropathy;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]Trade Name: Kiovig
Product Name: Kiovig
Erasmus MCNULLNot RecruitingFemale: yes
Male: yes
Phase 4Netherlands
27NCT01951924December 201320/9/2013LIME Study (LFB IVIg MMN Efficacy Study)A European, Randomised, Double-blind, Active Comparator Controlled, Cross-over, Efficacy and Safety Study of a New 10% Ready To-use Liquid Human Intravenous Immunoglobulin (I10E) Versus Kiovig® in Patients With Multifocal Motor NeuropathyMotor Neuron DiseaseDrug: Biological : I10E (Human normal Immunoglobulin for intravenous administration 100mg/mL);Drug: Biological: Kiovig® (Human normal Immunoglobulin for intravenous administration 100mg/mL)Laboratoire français de Fractionnement et de BiotechnologiesTFS Trial Form SupportCompleted18 Years80 YearsBoth23Phase 3France;Italy;Spain;United Kingdom
28EUCTR2012-001995-12-ES12/07/201312/07/2013A European, randomised, double-blind, active comparator-controlled, cross-over, efficacy and safety study of a new 10% ready-to-use liquid human intravenous immunoglobulin (I10E) versus Kiovig® in patients with Multifocal Motor NeuropathyA European, randomised, double-blind, active comparator-controlled, cross-over, efficacy and safety study of a new 10% ready-to-use liquid human intravenous immunoglobulin (I10E) versus Kiovig® in patients with Multifocal Motor Neuropathy Multifocal motor neuropathy (MMN)
MedDRA version: 16.0Level: PTClassification code 10065579Term: Multifocal motor neuropathySystem Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: KIOVIG
Product Name: KIOVIG
INN or Proposed INN: HUMAN NORMAL IMMUNOGLOBULIN
Other descriptive name: HUMAN NORMAL IMMUNOGLOBULIN (IV)
Product Name: human normal immunoglobulin for intravenous administration
Product Code: I10E
INN or Proposed INN: HUMAN NORMAL IMMUNOGLOBULIN
Other descriptive name: HUMAN NORMAL IMMUNOGLOBULIN (IV)
LFB BIOTECHNOLOGIESNULLNot RecruitingFemale: yes
Male: yes
20Phase 3France;Spain;United Kingdom
29EUCTR2012-001995-12-FR03/07/201304/04/2014A European, randomised, double-blind, active comparator-controlled, cross-over, efficacy and safety study of a new 10% ready-to-use liquid human intravenous immunoglobulin (I10E) versus Kiovig® in patients with Multifocal Motor NeuropathyA European, randomised, double-blind, active comparator-controlled, cross-over, efficacy and safety study of a new 10% ready-to-use liquid human intravenous immunoglobulin (I10E) versus Kiovig® in patients with Multifocal Motor Neuropathy Multifocal motor neuropathy (MMN)
MedDRA version: 16.1Level: PTClassification code 10065579Term: Multifocal motor neuropathySystem Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: KIOVIG
Product Name: KIOVIG
INN or Proposed INN: HUMAN NORMAL IMMUNOGLOBULIN
Other descriptive name: HUMAN NORMAL IMMUNOGLOBULIN (IV)
Product Name: human normal immunoglobulin for intravenous administration
Product Code: I10E
INN or Proposed INN: HUMAN NORMAL IMMUNOGLOBULIN
Other descriptive name: HUMAN NORMAL IMMUNOGLOBULIN (IV)
LFB BIOTECHNOLOGIESNULLNot RecruitingFemale: yes
Male: yes
20Phase 3France;Spain;United Kingdom
30EUCTR2013-001428-20-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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
31EUCTR2011-003448-28-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
32EUCTR2011-003448-28-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
33EUCTR2011-003448-28-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
34EUCTR2011-003448-28-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
35EUCTR2011-003448-28-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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
36EUCTR2011-003448-28-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
37EUCTR2011-003448-28-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
38EUCTR2011-003448-28-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
39EUCTR2009-017672-24-FI30/11/201010/09/2010This research study will investigate whether the investigational medicine IgPro10 is efficient and safe for patients with chronic inflammatory demyelinating polyneuropathy (CIDP).A single-arm study to demonstrate the efficacy and safety of Privigen in the treatment of subjects with chronic inflammatory demyelinating polyneuropathy (CIDP) Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)
MedDRA version: 14.0Level: PTClassification code 10061811Term: Demyelinating polyneuropathySystem Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Trade Name: Privigen®
INN or Proposed INN: Human normal immunoglobulin G (IgG > 98% purity)
Other descriptive name: HUMAN NORMAL IMMUNOGLOBULIN (IV)
CSL Behring GmbHNULLNot RecruitingFemale: yes
Male: yes
30Finland
40EUCTR2009-017672-24-BE13/09/201007/07/2010A single-arm study to demonstrate the efficacy and safety of Privigen in the treatment of subjects with chronic inflammatory demyelinating polyneuropathy (CIDP)A single-arm study to demonstrate the efficacy and safety of Privigen in the treatment of subjects with chronic inflammatory demyelinating polyneuropathy (CIDP) Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)
MedDRA version: 13.1Level: PTClassification code 10061811Term: Demyelinating polyneuropathySystem Organ Class: 10029205 - Nervous system disorders
Trade Name: Privigen®
INN or Proposed INN: Human normal immunoglobulin G (IgG > 98% purity)
Other descriptive name: HUMAN NORMAL IMMUNOGLOBULIN (IV)
CSL Behring GmbHNULLNot RecruitingFemale: yes
Male: yes
30Phase 3Finland;Belgium
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
41EUCTR2009-013841-27-DK17/12/200927/10/2009A Randomized, Double-Blind, Placebo Controlled, Cross-over Study of the Effectiveness of Immune Globulin Intravenous (Human), 10% (IGIV, 10%) for the Treatment of Multofocl Motor Neuropathy - IGIV, 10% MMN TrialA Randomized, Double-Blind, Placebo Controlled, Cross-over Study of the Effectiveness of Immune Globulin Intravenous (Human), 10% (IGIV, 10%) for the Treatment of Multofocl Motor Neuropathy - IGIV, 10% MMN Trial Multifocal motor neuropathy
MedDRA version: 12.0Level: LLTClassification code 10065579Term: Multifocal motor neuropathy
Trade Name: KIOVIG 100 mg/ml solution for infusion
Product Name: IGIV, 10%
Other descriptive name: HUMAN NORMAL IMMUNOGLOBULIN (IV)
Baxter Innovations GmbHNULLNot RecruitingFemale: yes
Male: yes
40Denmark
42EUCTR2007-000710-37-GB10/04/200815/02/2008A multicentre study of subcutaneous immunoglobulin in patients with Multifocal Motor Neuropathy (MMN)A multicentre study of subcutaneous immunoglobulin in patients with Multifocal Motor Neuropathy (MMN) Patients with multifocal motor neuropathy, who are treated successful with IVIG and had a stable IVIG treatment schedule for at least 12 weeks prior to screening.
MedDRA version: 9.1 Level: LLT Classification code 10065579 Term: Multifocal motor neuropathy
CSL Behring AGNULLNot Recruiting Female: yes
Male: yes
10 Human pharmacology (Phase 1): no Therapeut1c exploratory (Phase 2): yes Therapeut1c conf1rmatory - (Phase 3): no Therapeut1c use (Phase 4): noGermany;Italy;United Kingdom
43EUCTR2007-000710-37-DE10/12/200710/09/2007A multicentre study of subcutaneous immunoglobulin in patients with Multifocal Motor Neuropathy (MMN)A multicentre study of subcutaneous immunoglobulin in patients with Multifocal Motor Neuropathy (MMN) Patients with multifocal motor neuropathy, who are treated successful with IVIG and had a stable IVIG treatment schedule for at least 12 weeks prior to screening.
MedDRA version: 9.1Level: LLTClassification code 10065579Term: Multifocal motor neuropathy
Trade Name: Vivaglobin
Product Name: Vivaglobin
Other descriptive name: IMMUNOGLOBULIN G
CSL Behring AGNULLNot RecruitingFemale: yes
Male: yes
10United Kingdom;Germany;Italy
44EUCTR2005-001136-76-IT09/07/200707/09/2007Double blind Randomized Controlled trial of prolonged treatment of chronic inflammatory demyelinating polyradiculoneuropathy (CIDP)with high dose intravenous immunoglobulins (IVIg) or intravenous metilprednisolone (IVMP). A phase III study. - IVIg CIDPDouble blind Randomized Controlled trial of prolonged treatment of chronic inflammatory demyelinating polyradiculoneuropathy (CIDP)with high dose intravenous immunoglobulins (IVIg) or intravenous metilprednisolone (IVMP). A phase III study. - IVIg CIDP Chronic inflammatory demyelinating polyradiculoneuropathy (CIDP)
MedDRA version: 14.1Level: PTClassification code 10057645Term: Chronic inflammatory demyelinating polyradiculoneuropathySystem Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: IGVENA*FL 200ML 10G+SET
INN or Proposed INN: Immunoglobulins, normal human, for intravascular adm.
KEDRIONNULLNot RecruitingFemale: yes
Male: yes
Phase 3Italy
45NCT01349270June 20045/5/2011Randomized Open-label Trial to Compare Efficacy and Tolerance of Corticosteroids and IVIgMulticentre Randomized Open-label Trial to Compare Efficacy and Tolerance of Corticosteroids and IVIg in Patients With Chronic Inflammatory Demyelinating Polyneuropathy on a One Year Follow upDemyelinating PolyneuropathyDrug: Immunoglobulin perfusion;Drug: PrednisoneCentre Hospitalier Universitaire de Saint EtienneLaboratoire français de Fractionnement et de BiotechnologiesCompleted18 Years80 YearsBoth40Phase 3France